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Effects of Synbiotics on FC and Other Contributing Factors

Primary Purpose

Functional Constipation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Synbiotic
Placebo
Sponsored by
Universiti Putra Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Constipation focused on measuring Prevalence, functional constipation, Rome III criteria, Bristol Stool Form Scale, defecation frequency, PAC-SYM, PAC-QOL, randomised controlled trial (RCT), synbiotic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Malaysian of either gender;
  • 18 to 65 years old;
  • Body mass index (BMI) 16.0 to 29.9 kg/m2;
  • Positively diagnosed with functional constipation with Rome III-defined constipation module by the gastroenterologist

Exclusion Criteria:

  • Vulnerable groups of pregnant and breastfeeding women;
  • Physically or mentally handicapped individuals;
  • Diagnosed with organic constipation (constipation associated with any neoplastic diseases, neuropathy or mechanical obstruction);
  • Diagnosed with cardiovascular diseases, diabetes mellitus, cancer, neurological disease or other serious illnesses or severe medical complications;
  • Faced alarm features indicative of colorectal cancer, metabolic disease and a history of gastrointestinal surgery.

To avoid the likelihood of co-intervention bias, the following respondents were excluded:

  • On gastrointestinal medications;
  • Consumed probiotics or synbiotic products more than once a week in two weeks preceding screening or during intervention period;
  • Regularly used laxatives (more than once per week), used anticholinergics, anti-diarrheals, antibiotics or laxative in two weeks preceding screening or at any point during intervention.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Synbiotic

    Placebo

    Arm Description

    The product contained three clinically studied active ingredients namely inulin-oligofructose (prebiotic; derived from chicory root), at least 6 billion (B) colony forming unit (CFU) of Lactobacillus plantarum LP01 (probiotic) and 4 B CFU of Bifidobacterium lactis BB12 (probiotic) per sachet.

    Placebo contains only maltodextrin without any active ingredients, equally same in physical form, freeze-dried white powder with characteristic odor and water soluble as the synbiotic supplement.

    Outcomes

    Primary Outcome Measures

    Defecation frequency
    Defecation frequency was measured through participants' self reported defecation frequency in a week.
    Stool types - Bristol Stool Form (BSF) Scale
    BSF scale was used to characterise human stools to seven classifications using seven pictorial presentation of stool types.Type 1 stool shows the very slow transit time with longest time spent in the colon whereas Type 7 indicates the least time spent in the colon and has fast bowel transit time. Meanwhile, Type 4 is the most ideal stool type optimal colonic transit time.
    Constipation symptoms - Patients Assessment of Constipation Symptoms (PAC-SYM)
    PAC-SYM consists of a total of 12 questions includes abdominal symptoms, rectal symptoms, and stool symptoms. It comprised with a 5-point Likert scale ranging from 0 (Absent) to 4 (Very severe). The values of subscales and total scores for PAC-SYM were then computed as average item response within the scales and for the global score. Lower score obtained indicates less symptom severity.

    Secondary Outcome Measures

    Quality of life - Patients Assessment of Constipation Quality of Life (PAC-QOL)
    Quality of life was measured using Patients Assessment of Constipation Quality of Life (PAC-QOL). PAC-QOL consists of a total of 28 questions which was grouped into four domains include physical discomfort, psychological discomfort, worries and concerns, and satisfaction. It comprised with a 5-point Likert scale ranging from 0 (Not at all/None of the time) to 4 (Extremel/All of the time).The values of subscales and total scores for PAC-QOL scores were then computed as average item response within the scales and for the global score. Lower score point indicates a better quality of life of the respective participant.
    Psychological factor - Depression, Anxiety, and Stress scale (DASS)
    Psychological factor was measured using Depression, Anxiety, and Stress scale (DASS). DASS was used to self-report the severity of depression, anxiety and stress level. The questionnaire based on 4-point Likert scale, ranging from 0 (Did not apply to me at all) to 3 (Applied to me very much, or most of the time). The scores of depression, anxiety, and stress were summated for the relevant items followed by categorised to the severity of the condition. Lower score point indicates a less severity of the respective participant.

    Full Information

    First Posted
    October 16, 2018
    Last Updated
    November 5, 2020
    Sponsor
    Universiti Putra Malaysia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04620317
    Brief Title
    Effects of Synbiotics on FC and Other Contributing Factors
    Official Title
    Effects of Synbiotics on Functional Constipation and Other Contributing Factors Among Constipated Individuals in Serdang, Selangor, Malaysia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (Actual)
    Primary Completion Date
    April 2016 (Actual)
    Study Completion Date
    January 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universiti Putra Malaysia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Prevalence of functional constipation (FC) was first determined with 15.2% reported. Next, a 16-week randomised, double-blind, placebo-controlled study conducted to assess the improvement in functional constipation among the respective individuals by using synbiotic supplement. Throughout the intervention, it was reported that significant improvements for defecation frequency, Bristol Stool Form (BSF) scale, and Patients Assessment of Constipation Symptoms (PAC-SYM) scores were reported within synbiotic group (p < 0.001). However, no significant different was reported when compared both groups as placebo group was found to have significant within-group difference too. Placebo effect was suspected in this study.
    Detailed Description
    Digestive system disease is the top ten principal causes of morbidity and mortality among Malaysians whereby functional constipation (FC) is the commonest functional gastrointestinal disorders (FGIDs) reported. Although numerous treatments are available, but over-the-counter drugs which have low product safety and possible toxicity were always given as the treatment option. Synbiotic have been well-studied to improve digestive health includes constipation. Thus, the objectives of this study were to determine the prevalence of FC and to evaluate the effects of synbiotic supplement on improving FC symptoms and contributing factors among constipated individuals in Serdang, Selangor. This study comprised of two parts which were screening and intervention part. The prevalence of functional constipation was relatively high in the study community. Synbiotic supplement was effective in the improvement of functional constipation symptoms, quality of life, and psychological factors. However, the positive improvement in placebo group indicated the existence of placebo effects which led to the improvement in quality of life and changes in psychological factors. Therefore, the current findings are useful information for future intervention in improving functional constipation symptoms.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Functional Constipation
    Keywords
    Prevalence, functional constipation, Rome III criteria, Bristol Stool Form Scale, defecation frequency, PAC-SYM, PAC-QOL, randomised controlled trial (RCT), synbiotic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    85 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Synbiotic
    Arm Type
    Active Comparator
    Arm Description
    The product contained three clinically studied active ingredients namely inulin-oligofructose (prebiotic; derived from chicory root), at least 6 billion (B) colony forming unit (CFU) of Lactobacillus plantarum LP01 (probiotic) and 4 B CFU of Bifidobacterium lactis BB12 (probiotic) per sachet.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo contains only maltodextrin without any active ingredients, equally same in physical form, freeze-dried white powder with characteristic odor and water soluble as the synbiotic supplement.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Synbiotic
    Intervention Description
    10 billion (B) colony forming unit (CFU) of Lactobacillus plantarum LP01, Bifidobacterium lactis BB12, and inulin oligofructose
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Non-active ingredients - Maltodextrins
    Primary Outcome Measure Information:
    Title
    Defecation frequency
    Description
    Defecation frequency was measured through participants' self reported defecation frequency in a week.
    Time Frame
    16 weeks
    Title
    Stool types - Bristol Stool Form (BSF) Scale
    Description
    BSF scale was used to characterise human stools to seven classifications using seven pictorial presentation of stool types.Type 1 stool shows the very slow transit time with longest time spent in the colon whereas Type 7 indicates the least time spent in the colon and has fast bowel transit time. Meanwhile, Type 4 is the most ideal stool type optimal colonic transit time.
    Time Frame
    16 weeks
    Title
    Constipation symptoms - Patients Assessment of Constipation Symptoms (PAC-SYM)
    Description
    PAC-SYM consists of a total of 12 questions includes abdominal symptoms, rectal symptoms, and stool symptoms. It comprised with a 5-point Likert scale ranging from 0 (Absent) to 4 (Very severe). The values of subscales and total scores for PAC-SYM were then computed as average item response within the scales and for the global score. Lower score obtained indicates less symptom severity.
    Time Frame
    16 weeks
    Secondary Outcome Measure Information:
    Title
    Quality of life - Patients Assessment of Constipation Quality of Life (PAC-QOL)
    Description
    Quality of life was measured using Patients Assessment of Constipation Quality of Life (PAC-QOL). PAC-QOL consists of a total of 28 questions which was grouped into four domains include physical discomfort, psychological discomfort, worries and concerns, and satisfaction. It comprised with a 5-point Likert scale ranging from 0 (Not at all/None of the time) to 4 (Extremel/All of the time).The values of subscales and total scores for PAC-QOL scores were then computed as average item response within the scales and for the global score. Lower score point indicates a better quality of life of the respective participant.
    Time Frame
    16 weeks
    Title
    Psychological factor - Depression, Anxiety, and Stress scale (DASS)
    Description
    Psychological factor was measured using Depression, Anxiety, and Stress scale (DASS). DASS was used to self-report the severity of depression, anxiety and stress level. The questionnaire based on 4-point Likert scale, ranging from 0 (Did not apply to me at all) to 3 (Applied to me very much, or most of the time). The scores of depression, anxiety, and stress were summated for the relevant items followed by categorised to the severity of the condition. Lower score point indicates a less severity of the respective participant.
    Time Frame
    16 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Malaysian of either gender; 18 to 65 years old; Body mass index (BMI) 16.0 to 29.9 kg/m2; Positively diagnosed with functional constipation with Rome III-defined constipation module by the gastroenterologist Exclusion Criteria: Vulnerable groups of pregnant and breastfeeding women; Physically or mentally handicapped individuals; Diagnosed with organic constipation (constipation associated with any neoplastic diseases, neuropathy or mechanical obstruction); Diagnosed with cardiovascular diseases, diabetes mellitus, cancer, neurological disease or other serious illnesses or severe medical complications; Faced alarm features indicative of colorectal cancer, metabolic disease and a history of gastrointestinal surgery. To avoid the likelihood of co-intervention bias, the following respondents were excluded: On gastrointestinal medications; Consumed probiotics or synbiotic products more than once a week in two weeks preceding screening or during intervention period; Regularly used laxatives (more than once per week), used anticholinergics, anti-diarrheals, antibiotics or laxative in two weeks preceding screening or at any point during intervention.

    12. IPD Sharing Statement

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    Effects of Synbiotics on FC and Other Contributing Factors

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