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Evaluation of Changes in Bowel Movement Frequency Following the Consumption of PHGG Compared to Placebo (TYPHOON-02)

Primary Purpose

Constipation - Functional

Status
Recruiting
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
PHGG
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Constipation - Functional

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Men or women aged 18-75. Adapted Rome IV Criteria of functional constipation* or IBSconstipation** for a minimum of 3 months *1-2 SBM/week and at least 1 of the following at least 30% of the time: Bristol stool scale 1-2 Straining Sense of incomplete evacuation Sense of stool blockage Need of digital maneuvers Subjects with IBS-C: the above constipation criteria + abdominal pain are allowed. Ability to understand the participant information sheet and instructions, and able to provide informed consent. Access to a suitable smartphone device (Android or iOS) with ability to download and complete the study e-Diary daily for the duration of the trial. Exclusion Criteria: Pregnant women or breastfeeding. Organic chronic gastrointestinal disease or complication (such as, but not limited to, Inflammatory Bowel Disease, Microscopic colitis, Eosinophilic gastroenteritis, Radiation-related enterocolitis, Coeliac disease). Subjects with a diagnosed food allergy or hypersensitive to any of the components of the study product. Subjects with chronic diarrhea. Active peptic ulcer. Major gastrointestinal or colonic surgery (such as, gastric bypass or any other obesity or metabolic interventions including endoscopic procedures or devices, any gastro-intestinal or colonic resection); cholecystectomy and appendectomy are allowed. Neurologic or other clinically significant comorbid diseases that may affect gastrointestinal function, such as multiple sclerosis, spinal cord injury or Hirschsprung disease. Illness that may preclude the participant's ability to complete the study or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness, severe cardiovascular disease, chronic renal failure or eating disorders) or any other serious illness resulting in >2 weeks inability to work in the 3 months before the study start. Participants with clinically significant (as per physician judgement) co-morbid illnesses such as cardiovascular, endocrine (e.g. hypothyroidism, diabetes), renal, or other chronicdisease (e.g. reduced mobility or increased fragility). Active alcohol, drug, or medication abuse (as per clinician judgement). Self-reported symptoms suggestive of pelvic organ prolapse as per clinician judgement, such as feeling of pressure or fullness in the pelvic area, intra vaginal discomfort, painful intercourse, and urinary problems. Moderate or severe active local anorectal problems such as recurrent anal fissures, frequent bleeding, large prolapsing hemorrhoids. Any clinically relevant abnormalities detected during the physical examination or any alarm features in the medical history such as sudden unintentional weight loss (>10% in 3 months), frequent rectal bleeding not caused by anal fissures or hemorrhoids, recent change in bowel habit (<3 months), severe abdominal pain and stool positive for occult blood. Regular (i.e. daily or weekly) use of PHGG within 6 months of screening. Participation in another study with any investigational product within 6 months of randomization for drug study and within 2 months of randomization for a nutritional study. Investigator believes that the participant is physically or mentally unfit to participate in the trial. Participants currently of childbearing potential, but not using an effective method of contraception, as determined by the investigator. Any participant who is an employee of the study site or an Atlantia Clinical Trials employee or their close family member or a member of their household.

Sites / Locations

  • Atlantia Food Clinical TrialsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

PHGG fiber

Placebo Maltodextrin

Arm Description

Partially Hydrolyzed Guar Gum (PHGG) in powder formulation, is to be consumed orally adding water or juice. One serving per day.

Maltodextrin in powder formulation is to be consumed orally adding water or juice. One serving per day.

Outcomes

Primary Outcome Measures

Change in Spontaneous Bowel Movements
Change in mean weekly frequency of Spontaneous Bowel Movements (SBM) as measured by the daily bowel diary from baseline to end of treatment period. Frequency will be defined as the mean weekly number of SBM during the 2-week run-in period prior to V0, for baseline, and during the final 2 weeks of the intervention period, for end of treatment.

Secondary Outcome Measures

Change in frequency of Complete Spontaneous Bowel Movements
Change in mean weekly frequency of Complete Spontaneous Bowel Movements (CSBM) as measured by the daily bowel diary, from baseline to the end of treatment period.
Change in stool consistency
Change in stool consistency as measured by the Bristol stool scale, from baseline to end of intervention. The minimum and maximum values are 1 to 7. The extremes scores mean worse outcome. The middle or the scale mean the better outcome.
Change in constipation related symptoms
Change in constipation related symptoms from baseline to end of intervention as measured by the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire. The minimum and maximum values are 1 to 48. The higher score means worse outcome.

Full Information

First Posted
January 26, 2023
Last Updated
February 13, 2023
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT05714410
Brief Title
Evaluation of Changes in Bowel Movement Frequency Following the Consumption of PHGG Compared to Placebo
Acronym
TYPHOON-02
Official Title
Evaluation of Changes in Bowel Movement Frequency Following the Consumption of Partially Hydrolyzed Guar Gum (PHGG) in Adults With Constipation as Compared to Placebo (Typhoon 2)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2023 (Actual)
Primary Completion Date
October 23, 2023 (Anticipated)
Study Completion Date
October 23, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

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
Evaluation of Changes in Bowel Movement Frequency Following the Consumption of Partially Hydrolyzed Guar Gum (PHGG) in Adults With Constipation as Compared to Placebo (Typhoon 2)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation - Functional

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PHGG fiber
Arm Type
Active Comparator
Arm Description
Partially Hydrolyzed Guar Gum (PHGG) in powder formulation, is to be consumed orally adding water or juice. One serving per day.
Arm Title
Placebo Maltodextrin
Arm Type
Placebo Comparator
Arm Description
Maltodextrin in powder formulation is to be consumed orally adding water or juice. One serving per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
PHGG
Intervention Description
PHGG
Primary Outcome Measure Information:
Title
Change in Spontaneous Bowel Movements
Description
Change in mean weekly frequency of Spontaneous Bowel Movements (SBM) as measured by the daily bowel diary from baseline to end of treatment period. Frequency will be defined as the mean weekly number of SBM during the 2-week run-in period prior to V0, for baseline, and during the final 2 weeks of the intervention period, for end of treatment.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in frequency of Complete Spontaneous Bowel Movements
Description
Change in mean weekly frequency of Complete Spontaneous Bowel Movements (CSBM) as measured by the daily bowel diary, from baseline to the end of treatment period.
Time Frame
6 weeks
Title
Change in stool consistency
Description
Change in stool consistency as measured by the Bristol stool scale, from baseline to end of intervention. The minimum and maximum values are 1 to 7. The extremes scores mean worse outcome. The middle or the scale mean the better outcome.
Time Frame
6 weeks
Title
Change in constipation related symptoms
Description
Change in constipation related symptoms from baseline to end of intervention as measured by the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire. The minimum and maximum values are 1 to 48. The higher score means worse outcome.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women aged 18-75. Adapted Rome IV Criteria of functional constipation* or IBSconstipation** for a minimum of 3 months *1-2 SBM/week and at least 1 of the following at least 30% of the time: Bristol stool scale 1-2 Straining Sense of incomplete evacuation Sense of stool blockage Need of digital maneuvers Subjects with IBS-C: the above constipation criteria + abdominal pain are allowed. Ability to understand the participant information sheet and instructions, and able to provide informed consent. Access to a suitable smartphone device (Android or iOS) with ability to download and complete the study e-Diary daily for the duration of the trial. Exclusion Criteria: Pregnant women or breastfeeding. Organic chronic gastrointestinal disease or complication (such as, but not limited to, Inflammatory Bowel Disease, Microscopic colitis, Eosinophilic gastroenteritis, Radiation-related enterocolitis, Coeliac disease). Subjects with a diagnosed food allergy or hypersensitive to any of the components of the study product. Subjects with chronic diarrhea. Active peptic ulcer. Major gastrointestinal or colonic surgery (such as, gastric bypass or any other obesity or metabolic interventions including endoscopic procedures or devices, any gastro-intestinal or colonic resection); cholecystectomy and appendectomy are allowed. Neurologic or other clinically significant comorbid diseases that may affect gastrointestinal function, such as multiple sclerosis, spinal cord injury or Hirschsprung disease. Illness that may preclude the participant's ability to complete the study or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness, severe cardiovascular disease, chronic renal failure or eating disorders) or any other serious illness resulting in >2 weeks inability to work in the 3 months before the study start. Participants with clinically significant (as per physician judgement) co-morbid illnesses such as cardiovascular, endocrine (e.g. hypothyroidism, diabetes), renal, or other chronicdisease (e.g. reduced mobility or increased fragility). Active alcohol, drug, or medication abuse (as per clinician judgement). Self-reported symptoms suggestive of pelvic organ prolapse as per clinician judgement, such as feeling of pressure or fullness in the pelvic area, intra vaginal discomfort, painful intercourse, and urinary problems. Moderate or severe active local anorectal problems such as recurrent anal fissures, frequent bleeding, large prolapsing hemorrhoids. Any clinically relevant abnormalities detected during the physical examination or any alarm features in the medical history such as sudden unintentional weight loss (>10% in 3 months), frequent rectal bleeding not caused by anal fissures or hemorrhoids, recent change in bowel habit (<3 months), severe abdominal pain and stool positive for occult blood. Regular (i.e. daily or weekly) use of PHGG within 6 months of screening. Participation in another study with any investigational product within 6 months of randomization for drug study and within 2 months of randomization for a nutritional study. Investigator believes that the participant is physically or mentally unfit to participate in the trial. Participants currently of childbearing potential, but not using an effective method of contraception, as determined by the investigator. Any participant who is an employee of the study site or an Atlantia Clinical Trials employee or their close family member or a member of their household.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeyesh Patel
Phone
+44 (0) 7880 467680
Email
jdpatel@aimmune.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Muckley, FRCPI
Organizational Affiliation
Altantia Food Clinical Trial
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlantia Food Clinical Trials
City
Cork
ZIP/Postal Code
T23 R50R
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atlantia FC Trials

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Changes in Bowel Movement Frequency Following the Consumption of PHGG Compared to Placebo

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