The Effect of Humiome® Post LB on Gut COMFort in healthY Adult Volunteers (NCT06937814) | Clinical Trial Compass
RecruitingNot Applicable
The Effect of Humiome® Post LB on Gut COMFort in healthY Adult Volunteers
Canada250 participantsStarted 2025-06-16
Plain-language summary
The goal of this double-blind, randomized placebo-controlled study is to evaluate the effect of an 8-week supplementation of Humiome ® Post LB (170 mg) on bowel movements in healthy adult volunteers compared to Placebo adjusted on baseline. The main question\[s\] it aims to answer \[is/are\]:
Does Humiome ® Post LB improve bowel movements with self-reported GI issues?
Participants will be provided Humiome ® Post LB (170 mg) for 8 weeks and asked to complete a study diary, questionnaires, and stool samples.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Be able to give written informed consent.
✓. Self-reported gastrointestinal issues defined as 10-20 bowel movements per week and a score of 5-6 for ≥20% of stools based on the BSS in the 2 weeks prior to baseline, as assessed by the Qualified Investigator (QI).
✓. Self-reported GI issues such as bloating, mild cramping, and urgency, as assessed by the QI.
✓. Be between 18 and 75 years of age, inclusive.
✓. Have a BMI of between 18.5 - 29.9 kg/m2, inclusive.
✓. Self-reported stable body weight (\<5% change) over the past 3 months.
✓. Be in general good health, as determined by the QI.
✓. Willing to avoid consuming prebiotic, probiotic, postbiotics, fiber-rich and dietary supplements, anti-diarrheal and anti-constipation medication until the end of the study (see Section 5.6).
Exclusion criteria
✕. Failure to meet any one of the inclusion criteria.
✕. Females who are pregnant, lactating or wish to become pregnant during the study.
✕. Are lactose intolerant or have any other hypersensitivity/allergy to any of the components of the test product.
✕. Meeting Irritable Bowel Syndrome (IBS) diagnostic criteria as defined by Rome IV criteria, i.e. having recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria:
What they're measuring
1
To evaluate the effect of Humiome ® Post LB (170 mg) supplementation on bowel movements in healthy adult volunteers compared to Placebo
✕. Associated with a change in frequency of stool.
✕. Associated with a change in form (appearance) of stool. Criteria need to be fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
✕. Have suffered from diarrhea (defined as ≥3 bowel movements per day and 6-7 on BSS) at any time two weeks prior to run-in, as assessed by the QI.