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Randomized, Placebo-Controlled, Double-Blind Study of Two Different Mixes of HMO-2FL and Humiome4 Post LB Postbiotic on Gastrointestinal Symptoms in Irritable Bowel Syndrome
Led by dsm-firmenich Switzerland AG · Updated on 2026-03-11
402
Participants Needed
12
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a randomized, placebo-controlled, double-blind clinical trial to evaluate the effects of two different mixes of Human Milk Oligosaccharide 2'-O-fucosyllactose (HMO-2FL) combined with Humiome4 Post LB postbiotic on gastrointestinal symptoms in adults with Irritable Bowel Syndrome (IBS). The study aims to compare these mixes with a placebo to better understand their impact on symptoms like abdominal pain, bloating, and bowel movement changes, using validated symptom scoring tools. Quality of life, gut health markers, and safety will also be assessed. Participants will be randomly assigned to one of three groups: one receiving a combination of 300 mg each of Humiome4 Post LB postbiotic and HMO-2FL, another receiving 100 mg of postbiotic and 500 mg of HMO-2FL, or a placebo group receiving microcrystalline cellulose. Each participant will take one capsule daily by mouth for six weeks, with the study maintaining a double-blind design to prevent bias. During the study, participants will undergo evaluations at the start, midpoint, and end of the six-week period, including symptom severity assessments with the IBS Symptom Severity Scale and quality of life questionnaires. Researchers will monitor abdominal pain, stool consistency, mental stress, gut permeability, stool pH, and use of rescue medication. Participants will also complete daily diaries via an app, and safety will be closely monitored throughout the trial period, which concludes by July 2026.
CONDITIONS
Brief Title
Study Evaluating the Efficacy of Different Mixes of HMO-2FL + Humiome® Post LB on IBS Gastrointestinal Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written and signed informed consent before any study assessments
- Male or female aged 18 to 70 years at consent
- Females of childbearing potential must have a negative pregnancy test and use effective contraception
- Fasting blood glucose less than or equal to 125 mg/dl
- Hemoglobin at least 10 g/dl
- Blood pressure less than or equal to 140/100 mm Hg
- Normal complete blood counts
- Thyroid stimulating hormone between 0.4 and 5.0 mIU/L
- Liver enzymes within twice the upper normal limit
- Creatinine within 1.5 times upper normal limit
- Meet Rome-IV IBS criteria with recurrent abdominal pain and specific stool form changes over the last 3 months
- Abdominal pain severity of 6 or more on an 11-point scale at screening and placebo run-in
- IBS Symptom Severity Scale score of at least 175 at screening
- Mentally stable with Perceived Stress Scale score 26 or less
- Understand study purpose and risks
- Willing to complete all study procedures and questionnaires
- Able to use app-based digital diary
You will not qualify if you...
- Diagnosed with mixed-type IBS (IBS-M)
- Use of investigational drugs within 30 days or 5 half-lives before screening
- Organic diseases like infections, inflammatory, metabolic, neurological, autoimmune disorders, or cancer
- History of surgical removal of stomach or intestines
- History or complications from inflammatory bowel diseases
- Diet-based intolerances such as gluten or lactose intolerance
- Drug or alcohol abuse within past 6 months
- Severe depression or anxiety affecting evaluation
- Uncontrolled hypertension or on antihypertensive meds
- Serious cardiovascular, respiratory, renal, hepatic, gastrointestinal (excluding IBS), blood, neurological, or psychiatric diseases
- Pregnant, breastfeeding, or planning pregnancy during study
- Type I or II diabetes mellitus
- Cancer diagnosis within past 5 years
- Immunocompromised conditions
- History of abdominal surgery
- Diarrhea from other causes
- Planning to fast more than 24 hours
- Active eating disorder
- Use of laxatives, herbal GI motility agents within 2 weeks prior to screening
- Use of probiotics, prebiotics, postbiotics, fiber supplements, FODMAP diet, or antibiotics within 4 weeks prior to screening
- Use of IBS-specific treatments within 4 weeks prior to screening
- Consume more than 2 standard alcoholic drinks daily in past 3 months
- Smokers in any form
- Allergy or sensitivity to probiotic products
- Cognitive impairment or inability to consent
- Abnormal lab results or medical/psychological conditions that may affect study completion or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants take one capsule daily of either one of two mixes containing HMO-2FL and Humiome® Post LB postbiotic or a placebo to assess effects on IBS symptoms.
Visits on Day 0, Day 21, and Day 42 for assessments
Trial Site Locations
Total: 12 locations
1
Shri. B. M. PatilMedical College,Hospital andResearch Centre
Vijayapura, Karnataka, India, 586103
Actively Recruiting
2
Shivam Hospital
Dombivali, Maharashtra, India, 421201
Actively Recruiting
3
Aster Aadhar Hospital
Kolhāpur, Maharashtra, India, 416012
Actively Recruiting
4
D Y Patil
Navi Mumbai, Maharashtra, India, 400706
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5
Dhanwantari Hospital
Pune, Maharashtra, India, 411002
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6
Silver Birch
Pune, Maharashtra, India, 411041
Actively Recruiting
7
Vishwaraj hospital
Pune, Maharashtra, India, 412201
Actively Recruiting
8
D Y Patil Hospital, Medical college and research centre
Thane, Maharashtra, India, 400706
Actively Recruiting
9
Dr. Naresh Bansal's Gastro & Liver Clinic
New Delhi, National Capital Territory of Delhi, India, 110058
Actively Recruiting
10
Jaipur National University Institute of Medical Sciences and Research Centre
Jaipur, Rajasthan, India, 302017
Actively Recruiting
11
Samvedna Hospital
New Colony, Ravindrapuri Varanasi, India, 221005
Actively Recruiting
12
Gleneagles Global Hospitals
Hyderabad, Telangana, India, 500004
Actively Recruiting
Research Team
D
Dr. Sanjay Vaze, MBBS
A
Asha More, BAMS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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