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

NCT05714410 | Completed

• 1 other identifier: 22.08.CLI
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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)

Conditions

Constipation - Functional

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (3)

• Change in frequency of Complete Spontaneous Bowel Movements

  6 weeks

• Change in stool consistency

  6 weeks

• Change in constipation related symptoms

  6 weeks

Study Arms (2)

PHGG fiber

ACTIVE COMPARATOR

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

Dietary Supplement: PHGG

Placebo Maltodextrin

PLACEBO COMPARATOR

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

Dietary Supplement: PHGG

Interventions

PHGG DIETARY_SUPPLEMENT

PHGG

PHGG fiber; Placebo Maltodextrin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Atlantia Food Clinical Trials

Cork, T23 R50R, Ireland

Location

Study Officials

• Martin Muckley, FRCPI

  Altantia Food Clinical Trial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 6, 2023
• Study Start: January 25, 2023
• Primary Completion: January 19, 2024
• Study Completion: January 19, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)