Study Evaluating the Efficacy of Different Mixes of HMO-2FL + Humiome® Post LB on IBS Gastrointestinal Symptoms
DORPHI
A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of Two Different Mixes of HMO-2FL + Humiome® Post LB Postbiotic (Postbiotic-LB) on Gastrointestinal Symptoms in Irritable Bowel Syndrome (IBS) Subjects
1 other identifier
interventional
402
1 country
12
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2025
CompletedFirst Posted
Study publicly available on registry
March 21, 2025
CompletedStudy Start
First participant enrolled
March 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2026
March 11, 2026
March 1, 2026
1.2 years
February 20, 2025
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB) on IBS symptoms as assessed by IBS Symptom Severity Scale (IBS-SSS), when compared to placebo
The IBS Severity Scoring System (IBS-SSS) will be used to assess symptom severity. Participants will rate their symptoms over the last 10 days on day 0 and day 42. The change in the average IBS severity score will be calculated and compared to the placebo group.
Day 0 & Day 42
Secondary Outcomes (13)
To assess the efficacy of daily consumption of two different mixes of HMO 2'-O-fucosyllactose + Humiome® Post LB postbiotic on IBS symptoms as assessed by IBS Symptom Severity Scale , when compared to placebo in individuals
Day 0, Day 21
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on IBS symptoms as assessed by IBS-SSS, when compared to baseline in individuals with IBS
Day 0, Day 21 and Day 42
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on Abdominal Pain severity compared to baseline, each other and placebo in individuals with
Day 0, Day 21 and Day 42
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose + Humiome® Post LB postbiotic on participant by Stool consistency (Bristol Stool Form Scale types 3, 4 & 5)
Time Frame: Day 0, Day 21 and Day 42
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose + Humiome® Post LB postbiotic on participant by Quality of Life score as assessed by IBS- QoL questionnaire
day 0, day 21, and day 42
- +8 more secondary outcomes
Other Outcomes (4)
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on gut microbiome composition compared to baseline, each other and placebo
day 0 and day 42
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on microbiome diversity compared to baseline, each other and placebo
day 0 and day 42
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on fecal metabolomics profile compared to baseline, each other and placebo
day 0 and day 42
- +1 more other outcomes
Study Arms (3)
MIX 1
ACTIVE COMPARATORHumiome® Post LB postbiotic 300 mg , Human Milk Oligosaccharides 2'-O-fucosyllactose 300 mg 1 capsule per day orally
MIX 2
ACTIVE COMPARATORHumiome® Post LB postbiotic 100 mg Human Milk Oligosaccharides 2'-O-fucosyllactose 500 mg 1 capsule per day orally
Placebo
PLACEBO COMPARATORMicrocrystalline 1 capsule per day orally
Interventions
Eligibility Criteria
You may not qualify if:
- Individuals with IBS-M.
- Treatment with an investigational drug within 30 days/5 half-lives of the drug (whichever longest) prior to screening visit.
- Individuals with organic disease like infectious diseases, inflammatory diseases, metabolic disorders, neurological diseases, autoimmune disorders, cancer etc. (to be ruled out by physician based on prior history and physical examination).
- Individuals with a history of surgical resection of the stomach, small intestine or large intestine.
- Individuals with a history of or complications from inflammatory bowel disease (Crohn's disease or ulcerative colitis), colitis and enteritis.
- Individuals with a history of any diet-based intolerance (gluten or lactose intolerance).
- Individuals with a history of drug or alcohol abuse within the past 6 months.
- Individuals with severe depression or an anxiety disorder, which could potentially affect the efficacy evaluation (as determined by the qualified investigator).
- Individuals with uncontrolled hypertension or on antihypertensive medications.
- Individuals with serious cardiovascular diseases, respiratory diseases, renal diseases, hepatic diseases, gastrointestinal diseases (excluding IBS), blood diseases or neurological or psychiatric diseases.
- Individuals who are pregnant, breastfeeding or planning on becoming pregnant throughout the course of the study.
- Individuals with Type I or Type II diabetes mellitus.
- Individuals with a history of or current diagnosis of any cancer diagnosed less than 5 years prior to screening. Individuals with cancer in full remission more than 5 years after diagnosis are acceptable.
- Individuals who are immuno-compromised (HIV positive, on antirejection medication, rheumatoid arthritis and other autoimmune disorders).
- Individuals with a history of abdominal surgery.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Shri. B. M. PatilMedical College,Hospital andResearch Centre
Vijayapura, Karnataka, 586103, India
Shivam Hospital
Dombivali, Maharashtra, 421201, India
Aster Aadhar Hospital
Kolhāpur, Maharashtra, 416012, India
D Y Patil
Navi Mumbai, Maharashtra, 400706, India
Dhanwantari Hospital
Pune, Maharashtra, 411002, India
Silver Birch
Pune, Maharashtra, 411041, India
Vishwaraj hospital
Pune, Maharashtra, 412201, India
D Y Patil Hospital, Medical college and research centre
Thane, Maharashtra, 400706, India
Dr. Naresh Bansal's Gastro & Liver Clinic
New Delhi, National Capital Territory of Delhi, 110058, India
Jaipur National University Institute of Medical Sciences and Research Centre
Jaipur, Rajasthan, 302017, India
Samvedna Hospital
New Colony, Ravindrapuri Varanasi, 221005, India
Gleneagles Global Hospitals
Hyderabad, Telangana, 500004, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mehdi Sadaghian, PhD
dsm-firmenich Switzerland AG
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2025
First Posted
March 21, 2025
Study Start
March 27, 2025
Primary Completion (Estimated)
May 30, 2026
Study Completion (Estimated)
July 30, 2026
Last Updated
March 11, 2026
Record last verified: 2026-03