Actively Recruiting
The Effect of Humiome® Post LB on Gut COMFort in healthY Adult Volunteers
Led by dsm-firmenich Switzerland AG · Updated on 2026-03-09
250
Participants Needed
1
Research Sites
41 weeks
Total Duration
On this page
Sponsors
D
dsm-firmenich Switzerland AG
Lead Sponsor
K
KGK Science Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effect of Humiome® Post LB on Gut COMFort in healthY Adult Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give written informed consent
- Self-reported gastrointestinal issues with 10-20 bowel movements per week and a Bristol Stool Scale score of 5-6 for at least 20% of stools in the 2 weeks before baseline
- Self-reported GI symptoms like bloating, mild cramping, and urgency
- Age between 18 and 75 years
- Body mass index (BMI) between 18.5 and 29.9 kg/m2
- Stable body weight (less than 5% change) over the past 3 months
- General good health as determined by the qualified investigator
- Willingness to avoid certain supplements and medications (prebiotic, probiotic, postbiotics, fiber-rich, anti-diarrheal, anti-constipation) until study end
- Willing to maintain current diet, lifestyle, and medication habits during the study
- For females not of child-bearing potential: sterilization or post-menopausal for at least 1 year
- For females of child-bearing potential: negative pregnancy test at baseline and use of approved birth control methods during the study
You will not qualify if you...
- Failure to meet any inclusion criteria
- Pregnant, lactating, or planning pregnancy during the study
- Lactose intolerance or allergy to test product components
- Diagnosed with Irritable Bowel Syndrome (IBS) per Rome IV criteria
- Experienced diarrhea (3 or more bowel movements per day with Bristol Stool Scale 6-7) in 2 weeks before run-in
- Presence of alarm symptoms like weight loss, rectal bleeding, or recent bowel habit changes
- Antibiotic use within 2 months before run-in
- Unstable hypertension (systolic 60 mmHg or diastolic 100 mmHg) unless stable on medication for 3 months
- History or current HIV, hepatitis, endocrine, cardiovascular, pulmonary, or biliary diseases
- Significant gastrointestinal diseases like Crohn's, ulcerative colitis, celiac disease, or colectomy
- Planned major surgery during study
- History of drug or alcohol abuse within 12 months
- Alcohol intake over 2 standard drinks per day
- Major dietary changes in past 3 months
- Currently vegetarian or vegan diet
- Planned holiday altering diet during study
- Planned major lifestyle changes during study
- Regular tobacco or nicotine use in past 6 months
- Chronic cannabinoid use more than twice per week
- Any condition or lifestyle factor that may affect study completion or safety
- Participation in other clinical studies within 30 days before run-in
AI-Screening
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Trial Site Locations
Total: 1 location
1
KGK Science Inc.
London, Ontario, Canada
Actively Recruiting
Research Team
E
Erin Lewis, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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