Actively Recruiting
Study Evaluating the Efficacy of Different Mixes of HMO-2FL + Humiome® Post LB on IBS Gastrointestinal Symptoms
Led by dsm-firmenich Switzerland AG · Updated on 2026-03-11
402
Participants Needed
12
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A randomized, placebo-controlled, double-blind clinical study to evaluate the efficacy of two different mixes of HMO-2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB) on Gastrointestinal Symptoms in individuals with Irritable Bowel Syndrome (IBS)
CONDITIONS
Official 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 the time of consent
- Females of childbearing potential must have a negative pregnancy test at screening and agree to use effective contraception or sexual abstinence
- Fasting blood glucose less than or equal to 125 mg/dl
- Hemoglobin level at least 10 g/dl
- Blood pressure less than or equal to 140/100 mm Hg
- Normal complete blood counts
- Thyroid stimulating hormone levels between 0.4 and 5.0 mIU/L
- Liver enzymes (SGOT and SGPT) within twice the upper normal limit
- Serum creatinine within 1.5 times the upper normal limit
- Meet Rome-IV criteria for IBS with specific bowel movement patterns and recurrent abdominal pain
- Abdominal pain severity of at least 6 on an 11-point scale at screening and during placebo run-in
- IBS Symptom Severity Scale score of at least 175 points at screening
- Mentally stable with perceived stress scale less than or equal to 26
- Understand study nature, risks, and agree to complete all study procedures
- Able to use an app-based digital diary
You will not qualify if you...
- Diagnosis of IBS-M subtype
- Use of investigational drugs within 30 days or 5 half-lives prior to screening
- Presence of organic diseases such as infections, inflammatory, metabolic, neurological, autoimmune diseases, or cancer
- History of surgical removal of stomach or intestines
- History or complications from inflammatory bowel diseases
- History of gluten or lactose intolerance
- Drug or alcohol abuse within past 6 months
- Severe depression or anxiety disorders affecting study evaluation
- Uncontrolled hypertension or use of antihypertensive medications
- Serious cardiovascular, respiratory, renal, hepatic, gastrointestinal (excluding IBS), blood, neurological or psychiatric diseases
- Pregnancy, breastfeeding, or pregnancy plans during the study
- Type I or II diabetes mellitus
- Cancer diagnosis within past 5 years except fully remitted cases
- Immunocompromised status
- History of abdominal surgery
- Diarrhea from other causes
- Planned fasting over 24 hours
- Active eating disorder
- Use of laxatives or herbal agents affecting gut motility within 2 weeks prior
- Use of pre/pro/post/synbiotics, HMOs, fiber supplements, FODMAP diet, or antibiotics within 4 weeks prior
- Use of IBS-specific treatments within 4 weeks prior
- Consuming more than 2 standard alcoholic drinks daily in past 3 months
- Smoking in any form
- Allergy or sensitivity to probiotic products
- Cognitive impairment or inability to give informed consent
- Abnormal lab results or medical/psychological conditions posing risk or inability to complete the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Actively Recruiting
5
Dhanwantari Hospital
Pune, Maharashtra, India, 411002
Actively Recruiting
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
CONTACT
A
Asha More, BAMS
CONTACT
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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