Back to resultsDose-ranging Efficacy of Polydextrose Supplement on Colonic Transit Time and Symptoms in Adults With Functional Constipation
Primary Purpose
Functional Constipation
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Litesse powder containing 12 g polydextrose
Litesse powder containing 8 g polydextrose
Litesse powder containing 4 g polydextrose
Placebo
Sponsored by
About this trial
This is an interventional other trial for Functional Constipation focused on measuring Constipation, Polydextrose, Dietary Fiber, PAC-QoL, Colonic Transit Time, PAC-SYM
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 70 years.
- Body mass index between 18.5 and 29.9 kg/m2 (encompasses normal weight and overweight).
If female, subject is not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation).
OR
Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:
Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System), Intrauterine devices, Double barrier method, Vasectomy of partner (shown successful as per appropriate follow-up), Tubal ligation, and Non-heterosexual lifestyle (same sex partner).
Meets the Rome III criteria for functional constipation as follows: (Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis):
Must meet 2 or more of the following criteria:
Straining during at least 25% of defecations, Lumpy or hard stools in at least 25% of defecations, Sensation of incomplete evacuation for at least 25% of defecations, Sensation of anorectal obstruction/blockage for at least 25% of defecations, Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor)
Fewer than three defecations per week
Loose stools are rarely present without the use of laxatives
Insufficient criteria for irritable bowel syndrome
- Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects.
- Consent to the study and willing to comply with study product and methods.
- Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.
Exclusion Criteria:
- Major gastrointestinal complication (e.g. Crohn's disease, colitis, celiac disease)
- Prior abdominal surgery that in the opinion of the investigator may present a risk for the subject or confound study results.
- Clinically significant underlying systemic illness that may preclude the participant's ability to complete the trial or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness).
- Daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 2 weeks of screening and throughout the trial other than the provided study products.
- Laxative use within 48 hours of screening (rescue medication allowed for intolerable symptoms during study).
- Regular use of any drug or dietary supplement known to cause constipation (e.g. iron, opioids, sucralfate, misoprostol, 5-HT#-antagonists, antacids with magnesium, calcium or aluminum, antidiarrheal medication, anticholinergic agents, calcium supplements, calcium channel blockers, tricyclic antidepressants or NSAIDs), within 1 month before screening.
- Anticipated major dietary or exercise changes during the study.
- Systemic steroid use, within 1 month before screening.
- Eating disorder.
- Contraindication to dairy products (e.g., intolerance to lactose or any substance in the study product).
- History of alcohol, drug, or medication abuse.
- Pregnant or lactating female, or pregnancy planned during study period.
- Participation in another study with any investigational product within 60 days of screening.
- Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study.
- Subject under administrative or legal supervision.
- Subject who would receive more than 4500 Euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study.
Sites / Locations
- KGK Synergize Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Litesse powder containing 12 g polydextrose
Litesse powder containing 8 g polydextrose
Litesse powder containing 4 g polydextrose
Placebo
Arm Description
12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks
8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks
4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks
Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks
Outcomes
Primary Outcome Measures
Change in Colonic Transit Time From Baseline to Day 15
Assessed using abdominal x-ray. Subjects will take 24 radiopaque markers for 6 consecutive days (144 radiopaque markers in total) immediately preceding the x-ray dates.
Secondary Outcome Measures
Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15
Assessed using the PAC-SYM questionnaire (overall score, abdominal symptoms score, rectal symptoms score, and stool symptoms score).
The PAC-SYM was developed as a brief, easily administered tool to assess symptom frequency and severity of chronic constipation. The authors used a definition for constipation was based on the Rome II criteria. This 12-item self-report measure is divided into the 3 symptom subscales of: abdominal, rectal and stool subscales.
All items (sub-scores and the total score) are scored on a five-point Likert scale ranging from 0 (absence of symptom) to 4 (very severe) where lower scores are better. Scores for the total number of non-missing items within the subscale or total score are summed and divided by the total number of non-missing items for that subscale or total score.
Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15
Assessed using the PAC-QoL questionnaire (Overall Score, Worries and Concerns Score, Physical Discomfort Score, Psychosocial Discomfort Score, and Satisfaction Score)
The Patient Assessment of Constipation (PAC) was developed to address the need for a disease-specific patient-reported outcomes measure. It includes components from complementary symptom and quality of life questionnaires.
The PAC-QOL contains 28 items grouped into 4 subscales covering: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items).
A 5-point Likert response scale, ranging from 0 (not at all / none of the time) to 4 (extremely / all of the time), where lower scores are better. Scores are computed as the average non-missing item response within the subscale where each score is given equal weight; the global score is calculated as the mean of the 28-items.
Change in Bowel Function Index From Baseline to Day 15
Assessed using the Bowel Function Index questionnaire (total score, ease of defecation, feeling of incomplete bowel evacuation, and personal judgement of constipation).
Each of the three questions used a numerical analog scale (0 = easy/no difficulty/not at all, 100 = very strong/very difficult) for grading purposes. The three questions were calculated as single scores as well as by a total score defined as the average of the three questions.
Change in Adequate Relief of Constipation Symptoms From Baseline to Day 15
Assessed using single question dichotomous tool.
Adequate relief quantified the difference in the number of participants experiencing relief from constipation between participants supplemented with Litesse and those supplemented with a placebo at baseline and day 14. The units of analysis for the relief questionnaire were the number of participants who reported relief from constipation.
Change in Stool Frequency From Baseline to Day 15
Participants will record the number of defecations per day in a daily diary
Change in Stool Consistency From Baseline to Day 15
Stool consistency will be rated each day in a diary by using the Bristol Stool Scale Form.
Bristol Stool Scale:
The BSS is a categorical scale ranging from 1 to 7 that interprets the consistency of a single bowel movement; a single score is recorded and used for analysis. Lower scores are associated with hard and lumpy consistencies while higher scores are associated with soft or liquid consistencies. Generally, an optimal BSS scores ranges from 3 to 5.
Change in the Degree of Straining During Defecation From Baseline to Day 15
Degree of straining for each bowel movement will be recorded in a daily diary using a 5-point scale.
The degree of straining is a rating scale ranging from 1 (not at al) to 5 (an extreme amount) that interprets the degree to which an individual must strain during a unique defecation; a single core is recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of straining (1-5) where a lower score represented less straining.
Change in the Sensation of Complete Bowel Emptying From Baseline to Day 15
Sensation of complete bowel emptying for each bowel movement will be recorded in a daily diary on a dichotomous "yes" or "no" scale.
The change in the sensation was defined as the change from baseline to week 2 in the percentage of complete bowel movements (CBMs) between participants supplemented with Litesse and those supplemented with a placebo. It assessed whether the participant felt as though their bowel movement was complete. The units of analysis for the sensation of complete bowel emptying was the weekly percentage of complete bowel movements, for each participant at run-in (week -1), week 1 and week 2.
Change in the Severity of Abdominal Discomfort From Baseline to Day 15
Severity of abdominal discomfort will be recorded each day in a daily diary on a 5-point scale.
The severity of abdominal discomfort was calculated from a rating scale ranging from 1 (not at all) to 5 very severe); a single score was recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of discomfort where a lower score represented less straining.
Change in the Bloating Severity From Baseline to Day 15
Severity of bloating will be recorded each day in a daily diary on a 5-point scale.
The severity of abdominal bloating was calculated from a rating scale ranging from 1 (not at all) to 5 very severe); a single score was recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of bloating where a lower score represented less straining.
Overall Product Satisfaction
Participants will be asked to rate their overall satisfaction with the study product's ability to relieve their constipation symptoms on a 5-point ordinal scale.
The overall product satisfaction questionnaire consists of a single question that provides insight regarding the participants satisfaction on the product's ability to relieve constipation symptoms. The score that the participant indicates is considered the total score and no sub-scores are calculated. It is a rating scale that ranges from 1 (not at all satisfied) to 5 (very satisfied) where a higher score at the end-of-study indicates an improvement.
Full Information
NCT ID
NCT02314936
First Posted
December 8, 2014
Last Updated
April 10, 2018
Sponsor
KGK Science Inc.
Collaborators
DuPont Nutrition and Health
1. Study Identification
Unique Protocol Identification Number
NCT02314936
Brief Title
Dose-ranging Efficacy of Polydextrose Supplement on Colonic Transit Time and Symptoms in Adults With Functional Constipation
Official Title
Dose-ranging Efficacy of Supplementation With Polydextrose, a Dietary Fibre, on Colonic Transit Time and Gastrointestinal Symptoms in Adults With Functional Constipation: A Double-blind, Randomized, Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KGK Science Inc.
Collaborators
DuPont Nutrition and Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will investigate the effectiveness of Polydextrose, a dietary fiber, at decreasing Colonic Transit Time and the gastrointestinal symptoms of Functional Constipation. One quarter of the subjects will receive 12 g of Polydextrose daily, one quarter will receive 8 g of Polydextrose daily, one quarter will receive 4 g of Polydextrose daily and one quarter will receive a placebo daily.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Constipation
Keywords
Constipation, Polydextrose, Dietary Fiber, PAC-QoL, Colonic Transit Time, PAC-SYM
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Litesse powder containing 12 g polydextrose
Arm Type
Experimental
Arm Description
12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks
Arm Title
Litesse powder containing 8 g polydextrose
Arm Type
Experimental
Arm Description
8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks
Arm Title
Litesse powder containing 4 g polydextrose
Arm Type
Experimental
Arm Description
4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Litesse powder containing 12 g polydextrose
Other Intervention Name(s)
Litesse powder
Intervention Description
12 g polydextrose
Intervention Type
Dietary Supplement
Intervention Name(s)
Litesse powder containing 8 g polydextrose
Other Intervention Name(s)
Litesse powder
Intervention Description
8 g polydextrose, 4 g maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
Litesse powder containing 4 g polydextrose
Other Intervention Name(s)
Litesse powder
Intervention Description
4 g polydextrose, 8 g maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
12 g Maltodextrin
Primary Outcome Measure Information:
Title
Change in Colonic Transit Time From Baseline to Day 15
Description
Assessed using abdominal x-ray. Subjects will take 24 radiopaque markers for 6 consecutive days (144 radiopaque markers in total) immediately preceding the x-ray dates.
Time Frame
Baseline and Day 15
Secondary Outcome Measure Information:
Title
Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15
Description
Assessed using the PAC-SYM questionnaire (overall score, abdominal symptoms score, rectal symptoms score, and stool symptoms score).
The PAC-SYM was developed as a brief, easily administered tool to assess symptom frequency and severity of chronic constipation. The authors used a definition for constipation was based on the Rome II criteria. This 12-item self-report measure is divided into the 3 symptom subscales of: abdominal, rectal and stool subscales.
All items (sub-scores and the total score) are scored on a five-point Likert scale ranging from 0 (absence of symptom) to 4 (very severe) where lower scores are better. Scores for the total number of non-missing items within the subscale or total score are summed and divided by the total number of non-missing items for that subscale or total score.
Time Frame
Baseline and Day 15
Title
Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15
Description
Assessed using the PAC-QoL questionnaire (Overall Score, Worries and Concerns Score, Physical Discomfort Score, Psychosocial Discomfort Score, and Satisfaction Score)
The Patient Assessment of Constipation (PAC) was developed to address the need for a disease-specific patient-reported outcomes measure. It includes components from complementary symptom and quality of life questionnaires.
The PAC-QOL contains 28 items grouped into 4 subscales covering: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items).
A 5-point Likert response scale, ranging from 0 (not at all / none of the time) to 4 (extremely / all of the time), where lower scores are better. Scores are computed as the average non-missing item response within the subscale where each score is given equal weight; the global score is calculated as the mean of the 28-items.
Time Frame
Baseline and Day 15
Title
Change in Bowel Function Index From Baseline to Day 15
Description
Assessed using the Bowel Function Index questionnaire (total score, ease of defecation, feeling of incomplete bowel evacuation, and personal judgement of constipation).
Each of the three questions used a numerical analog scale (0 = easy/no difficulty/not at all, 100 = very strong/very difficult) for grading purposes. The three questions were calculated as single scores as well as by a total score defined as the average of the three questions.
Time Frame
Baseline and Day 15
Title
Change in Adequate Relief of Constipation Symptoms From Baseline to Day 15
Description
Assessed using single question dichotomous tool.
Adequate relief quantified the difference in the number of participants experiencing relief from constipation between participants supplemented with Litesse and those supplemented with a placebo at baseline and day 14. The units of analysis for the relief questionnaire were the number of participants who reported relief from constipation.
Time Frame
Baseline and Day 15
Title
Change in Stool Frequency From Baseline to Day 15
Description
Participants will record the number of defecations per day in a daily diary
Time Frame
14 day run-in and Week 2 of the 14-day supplementation period
Title
Change in Stool Consistency From Baseline to Day 15
Description
Stool consistency will be rated each day in a diary by using the Bristol Stool Scale Form.
Bristol Stool Scale:
The BSS is a categorical scale ranging from 1 to 7 that interprets the consistency of a single bowel movement; a single score is recorded and used for analysis. Lower scores are associated with hard and lumpy consistencies while higher scores are associated with soft or liquid consistencies. Generally, an optimal BSS scores ranges from 3 to 5.
Time Frame
14 day run-in and Week 2 of the 14-day supplementation period
Title
Change in the Degree of Straining During Defecation From Baseline to Day 15
Description
Degree of straining for each bowel movement will be recorded in a daily diary using a 5-point scale.
The degree of straining is a rating scale ranging from 1 (not at al) to 5 (an extreme amount) that interprets the degree to which an individual must strain during a unique defecation; a single core is recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of straining (1-5) where a lower score represented less straining.
Time Frame
14 day run-in and Week 2 of the 14-day supplementation period
Title
Change in the Sensation of Complete Bowel Emptying From Baseline to Day 15
Description
Sensation of complete bowel emptying for each bowel movement will be recorded in a daily diary on a dichotomous "yes" or "no" scale.
The change in the sensation was defined as the change from baseline to week 2 in the percentage of complete bowel movements (CBMs) between participants supplemented with Litesse and those supplemented with a placebo. It assessed whether the participant felt as though their bowel movement was complete. The units of analysis for the sensation of complete bowel emptying was the weekly percentage of complete bowel movements, for each participant at run-in (week -1), week 1 and week 2.
Time Frame
14 day run-in and Week 2 of the 14-day supplementation period
Title
Change in the Severity of Abdominal Discomfort From Baseline to Day 15
Description
Severity of abdominal discomfort will be recorded each day in a daily diary on a 5-point scale.
The severity of abdominal discomfort was calculated from a rating scale ranging from 1 (not at all) to 5 very severe); a single score was recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of discomfort where a lower score represented less straining.
Time Frame
14 day run-in and Week 2 of the 14-day supplementation period
Title
Change in the Bloating Severity From Baseline to Day 15
Description
Severity of bloating will be recorded each day in a daily diary on a 5-point scale.
The severity of abdominal bloating was calculated from a rating scale ranging from 1 (not at all) to 5 very severe); a single score was recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of bloating where a lower score represented less straining.
Time Frame
14 day run-in and Week 2 of the 14-day supplementation period
Title
Overall Product Satisfaction
Description
Participants will be asked to rate their overall satisfaction with the study product's ability to relieve their constipation symptoms on a 5-point ordinal scale.
The overall product satisfaction questionnaire consists of a single question that provides insight regarding the participants satisfaction on the product's ability to relieve constipation symptoms. The score that the participant indicates is considered the total score and no sub-scores are calculated. It is a rating scale that ranges from 1 (not at all satisfied) to 5 (very satisfied) where a higher score at the end-of-study indicates an improvement.
Time Frame
Assessed at Day 15 (end of study)
Other Pre-specified Outcome Measures:
Title
Change in Hemoglobin Levels From Baseline to Day 15
Description
Safety will be evaluated by measuring whole blood hematology (specifically hemoglobin in this outcome).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Hematocrit Levels From Screening to Day 15
Description
Safety will be evaluated by measuring the change in whole blood hematology (specifically hematocrit levels in this outcome).
Time Frame
Screening and Day 15 (end of study)
Title
Change in White Blood Cell Count From Baseline to Day 15
Description
Safety will be evaluated by measuring whole blood hematology (specifically white blood cell count in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Red Blood Cell Count From Baseline to Day 15
Description
Safety will be evaluated by measuring whole blood hematology (specifically red blood cell count in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Mean Corpuscular Volume From Baseline to Day 15
Description
Safety will be evaluated by measuring whole blood hematology (specifically mean corpuscular volume in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Mean Corpuscular Hemoglobin From Baseline to Day 15
Description
Safety will be evaluated by measuring whole blood hematology (specifically mean corpuscular hemoglobin in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Mean Corpuscular Hemoglobin Concentration From Baseline to Day 15
Description
Safety will be evaluated by measuring whole blood hematology (specifically mean corpuscular hemoglobin concentration in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Red Cell Distribution Width From Baseline to Day 15
Description
Safety will be evaluated by measuring whole blood hematology (specifically red cell distribution width in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Platelet Count From Baseline to Day 15
Description
Safety will be evaluated by measuring whole blood hematology (specifically platelet count in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Neutrophil Count From Baseline to Day 15
Description
Safety will be evaluated by measuring whole blood hematology (specifically neutrophil count in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Lymphocyte Count From Baseline to Day 15
Description
Safety will be evaluated by measuring whole blood hematology (specifically lymphocyte count in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Monocyte Count From Baseline to Day 15
Description
Safety will be evaluated by measuring whole blood hematology (specifically monocyte count in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Eosinophil Count From Baseline to Day 15
Description
Safety will be evaluated by measuring whole blood hematology (specifically eosinophil count in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Basophil Count From Baseline to Day 15
Description
Safety will be evaluated by measuring whole blood hematology (specifically basophil count in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Serum Glucose Concentration From Baseline to Day 15
Description
Safety will be evaluated by measuring blood serum variables (specifically glucose concentration in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Creatinine Levels in Blood From Baseline to Day 15
Description
Safety will be evaluated by measuring blood serum variables (specifically creatinine concentration in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Serum Urea Concentration From Baseline to Day 15
Description
Safety will be evaluated by measuring blood serum variables (specifically urea concentration in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Serum Estimated Globular Filtration Rate From Baseline to Day 15
Description
Safety will be evaluated by measuring blood serum variables (specifically estimated glomerular filtration rate in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Serum Sodium Concentration From Baseline to Day 15
Description
Safety will be evaluated by measuring blood serum variables (specifically sodium concentration in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Serum Potassium Concentration From Baseline to Day 15
Description
Safety will be evaluated by measuring blood serum variables (specifically potassium concentration in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Serum Chloride Concentration From Baseline to Day 15
Description
Safety will be evaluated by measuring blood serum variables (specifically chloride concentration in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Serum Calcium Concentration From Baseline to Day 15
Description
Safety will be evaluated by measuring blood serum variables (specifically calcium concentration in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Serum Carbon Dioxide Concentration From Baseline to Day 15
Description
Safety will be evaluated by measuring blood serum variables (specifically carbon dioxide concentration in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Serum Phosphate Concentration From Baseline to Day 15
Description
Safety will be evaluated by measuring blood serum variables (specifically phosphate concentration in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Serum Bilirubin Concentration From Baseline to Day 15
Description
Safety will be evaluated by measuring blood serum variables (specifically bilirubin concentration in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Serum Aspartate Transaminase Concentration From Baseline to Day 15
Description
Safety will be evaluated by measuring blood serum variables (specifically aspartate transaminase concentration in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Serum Alanine Transaminase Concentration From Baseline to Day 15
Description
Safety will be evaluated by measuring blood serum variables (specifically alanine transaminase concentration in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Serum Alkaline Phosphate Concentration From Baseline to Day 15
Description
Safety will be evaluated by measuring blood serum variables (specifically alkaline phosphate concentration in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Serum Gamma-Glutamyltransferase Concentration From Baseline to Day 15
Description
Safety will be evaluated by measuring blood serum variables (specifically gamma-glutamyltransferase concentration in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Serum C-Reactive Protein Concentration From Baseline to Day 15
Description
Safety will be evaluated by measuring blood serum variables (specifically C-reactive protein concentration in this outcome measure).
Time Frame
Screening and Day 15 (end of study)
Title
Change in Specific Gravity Urinalysis Parameter From Screening to Day 15
Description
Safety will be evaluated by measuring urine analyses (specifically specific gravity in this outcome measure). The reference range for specific gravity are 1.001 - 1.030 mmol/L, with no alerting or critical values.
Time Frame
Screening and Day 15 (end of study)
Title
Change in pH Urinalysis Parameter From Baseline to Day 15
Description
Safety will be evaluated by measuring urine analyses (specifically urine pH in this outcome measure). Urine pH reference range is between 5.0 - 8.0, with no alerting or critical values.
Time Frame
Screening and Day 15 (end of study)
Title
Number of Subjects With Adverse Events
Description
Adverse events were recorded in a daily diary during the 14-day run-in period and the 14-day treatment period. All types of adverse events as well as the total number of all adverse events reported were used in this outcome measure.
Time Frame
14 days run-in and 14 days treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age between 18 and 70 years.
Body mass index between 18.5 and 29.9 kg/m2 (encompasses normal weight and overweight).
If female, subject is not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation).
OR
Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:
Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System), Intrauterine devices, Double barrier method, Vasectomy of partner (shown successful as per appropriate follow-up), Tubal ligation, and Non-heterosexual lifestyle (same sex partner).
Meets the Rome III criteria for functional constipation as follows: (Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis):
Must meet 2 or more of the following criteria:
Straining during at least 25% of defecations, Lumpy or hard stools in at least 25% of defecations, Sensation of incomplete evacuation for at least 25% of defecations, Sensation of anorectal obstruction/blockage for at least 25% of defecations, Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor)
Fewer than three defecations per week
Loose stools are rarely present without the use of laxatives
Insufficient criteria for irritable bowel syndrome
Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects.
Consent to the study and willing to comply with study product and methods.
Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.
Exclusion Criteria:
Major gastrointestinal complication (e.g. Crohn's disease, colitis, celiac disease)
Prior abdominal surgery that in the opinion of the investigator may present a risk for the subject or confound study results.
Clinically significant underlying systemic illness that may preclude the participant's ability to complete the trial or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness).
Daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 2 weeks of screening and throughout the trial other than the provided study products.
Laxative use within 48 hours of screening (rescue medication allowed for intolerable symptoms during study).
Regular use of any drug or dietary supplement known to cause constipation (e.g. iron, opioids, sucralfate, misoprostol, 5-HT#-antagonists, antacids with magnesium, calcium or aluminum, antidiarrheal medication, anticholinergic agents, calcium supplements, calcium channel blockers, tricyclic antidepressants or NSAIDs), within 1 month before screening.
Anticipated major dietary or exercise changes during the study.
Systemic steroid use, within 1 month before screening.
Eating disorder.
Contraindication to dairy products (e.g., intolerance to lactose or any substance in the study product).
History of alcohol, drug, or medication abuse.
Pregnant or lactating female, or pregnancy planned during study period.
Participation in another study with any investigational product within 60 days of screening.
Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study.
Subject under administrative or legal supervision.
Subject who would receive more than 4500 Euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tetyana Pelipyagina, MD
Organizational Affiliation
KGK Science Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
KGK Synergize Inc.
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5R8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Dose-ranging Efficacy of Polydextrose Supplement on Colonic Transit Time and Symptoms in Adults With Functional Constipation
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