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Evaluation of Changes in Bowel Movement Frequency Following the Consumption of PHGG in Adults with Constipation | Clinical Trials | Clareo Health

COMPLETEDNA

Evaluation of Changes in Bowel Movement Frequency Following the Consumption of PHGG in Adults with Constipation

Evaluation of Changes in Bowel Movement Frequency Following the Consumption of Partially Hydrolyzed Guar Gum (PHGG) in Adults with Constipation

NCT04587635•Société des Produits Nestlé (SPN)

View on ClinicalTrials.gov

Summary

Evaluation of Changes in Bowel Movement Frequency Following the Consumption of Partially Hydrolyzed Guar Gum (PHGG) in Adults with Constipation

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Men or women aged 18-75, inclusive.
•2. Self-reported symptoms of constipation for a minimum of 3 months.
•3. Constipation symptoms according to the adapted Rome IV Diagnostic Questionnaire for Adults for Functional Constipation (Appendix 2) administered at screening.
•4. Cleveland Clinic constipation score (CCCS) of 8-20.
•5. Low-moderate fiber intake (≤18g) determined by the semi-quantitative food intake screener known as the Block Fiber Screener completed by site personnel.
•6. Ability to understand the participant information sheet and instructions, and able to provide informed consent.
•7. 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

•1. Pregnant women or breastfeeding.
•2. Ongoing other diagnosed gastrointestinal disease or complication (Crohn's disease, Ulcerative Colitis, Coeliac disease, chronic diarrhoea).
•3. Any clinically relevant abnormalities in the screening visit physical examination or 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.
•4. Prior abdominal surgery (including gastric bypass or laparoscopic banding), except cholecystectomy and appendectomy.
•5. Neurologic diseases such as multiple sclerosis, stroke, spinal cord injury, Hirschsprung disease.
•6. Chronic usage of any medication that in the opinion of the investigator would impact gut motility two weeks prior to the initial administration of study product or up to a minimum of 5 times the half-life of the medication if it has a long half-life.
•7. 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.
•8. Participants with co-morbid illnesses such as cardiovascular, endocrine, renal or other chronic disease likely to affect gut motility or limit normal functions (e.g. reduced mobility or increased fragility).
•9. Ongoing alcohol, drug, or medication abuse (anamnesis only).
•10. Self-reported symptoms of pelvic organ prolapse, such as feeling of pressure or fullness in the pelvic area, intra vaginal discomfort, painful intercourse and urinary problems.
+6 more criteria

Locations (1)

Atlantia Food Clinical Trial

Cork, Ireland

Key Dates

Start Date

September 16, 2020

Primary Completion Date

November 5, 2021

Completion Date

November 5, 2021

Last Updated

October 21, 2024

Enrollment

130

ACTUAL participants

Conditions

Constipation - Functional

Interventions

PHGG

DIETARY_SUPPLEMENT

Placebo

DIETARY_SUPPLEMENT

Chronic Ingestion of Fructooligosaccharide and Psyllium on Intestinal Transit in Women With Functional Constipation: A Randomized Crossover Trial

NCT07202481

Constipation - Functional

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RECRUITINGNA

Effects of Lactulose on Gut Microbiota and Metabolism in Diabetic Constipated Patients

NCT07065942

Diabetes MellitusConstipation - Functional

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 21, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of Changes in Bowel Movement Frequency Following the Consumption of PHGG in Adults with Constipation

Inclusion Criteria

Exclusion Criteria

Chronic Ingestion of Fructooligosaccharide and Psyllium on Intestinal Transit in Women With Functional Constipation: A Randomized Crossover Trial

Effects of Lactulose on Gut Microbiota and Metabolism in Diabetic Constipated Patients

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