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

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)

Study Overview

• Status: Recruiting
• Conditions: IBS (Irritable Bowel Syndrome)
• Intervention / Treatment: Dietary supplement: MIX 1; Dietary supplement: MIX 2; Dietary supplement: Placebo

Detailed Description

This study is a randomized, placebo-controlled, double-blind clinical trial designed to assess the efficacy of two distinct formulations combining Human Milk Oligosaccharide 2'-O-fucosyllactose (HMO-2FL) with Humiome® Post LB postbiotic (postbiotic-LB) in alleviating gastrointestinal symptoms in individuals with Irritable Bowel Syndrome (IBS). Participants will be randomly assigned to receive either of the two active formulations or a placebo, ensuring unbiased comparisons. We aim to evaluate changes in gastrointestinal symptoms, including abdominal pain, bloating, and bowel movement patterns, using validated symptom scoring tools. We will assess the quality of life, gut health biomarkers, and safety profiles. The study employs a double-blind design, where neither participants nor investigators will know the treatment assignments, maintaining the study's integrity. By comparing the effects of different HMO-2FL and postbiotic-LB combinations, this trial aims to provide evidence-based insights into novel dietary supplement options for IBS management, contributing to the growing field of gut health and microbiome-targeted solutions.

• Study Type: Interventional
• Enrollment (Estimated): 402
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Sanjay Vaze, MBBS; Phone Number: +918655670964; Email: sanjay.v@vediclifesciences.com
• Study Contact Backup: Name: Asha More, BAMS; Email: asha.m@vediclifesciences.com

Study Locations

• India
  • Karnataka
    • Vijayapura, Karnataka, India, 586103
      • Recruiting
      • Shri. B. M. PatilMedical College,Hospital andResearch Centre
      • Contact: Dr. Vijay Alakshmi, MBBS MD; Phone Number: +918792793848; Email: dr.viju21@yahoo.in
  • Maharashtra
    • Dombivali, Maharashtra, India, 421201
      • Recruiting
      • Shivam Hospital
      • Contact: Dr KushaL Bangar, MBBS MD; Phone Number: +919545664884; Email: dr.kushal.bangar83@gmail.com
    • Kolhāpur, Maharashtra, India, 416012
      • Recruiting
      • Aster Aadhar Hospital
      • Contact: Dr Amol Kulkarni, MBBS, DNB; Phone Number: +919130463328; Email: kamul102468@gmail.com
    • Navi Mumbai, Maharashtra, India, 400706
      • Recruiting
      • D Y Patil
      • Contact: Dr.Deepak Ahire, MBBS, DNB; Phone Number: diakahire33@g +910909908113; Email: dipakahire33@gmail.com
    • Pune, Maharashtra, India, 411041
      • Recruiting
      • Silver Birch
      • Contact: Dr Amar Raykantiwar, MBBS, DNB; Phone Number: +918451941050; Email: dr.amarray26@gmail.com
    • Pune, Maharashtra, India, 412201
      • Recruiting
      • Vishwaraj hospital
      • Contact: Dr Kiran Shinde, MBBS MD; Phone Number: +919986003257; Email: dr.kiranshinde@gmail.com
    • Pune, Maharashtra, India, 411002
      • Recruiting
      • Dhanwantari Hospital
      • Contact: Dr. Bharat Jain, MBBS, DNB; Phone Number: +918087448919; Email: dr_bharatjain@rediffmail.com
    • Thane, Maharashtra, India, 400706
      • Recruiting
      • D Y Patil Hospital, Medical college and research centre
      • Contact: Dr. Dipak Ahire, MBBS, DNB; Phone Number: +919099081133; Email: dipakahire33@gmail.com
  • National Capital Territory of Delhi
    • New Delhi, National Capital Territory of Delhi, India, 110058
      • Recruiting
      • Dr. Naresh Bansal's Gastro & Liver Clinic
      • Contact: Dr. Naresh Kumar Bansal, MBBS; Phone Number: +91987091962; Email: dr.nikhilprabhu@gmail.com
  • Rajasthan
    • Jaipur, Rajasthan, India, 302017
      • Recruiting
      • Jaipur National University Institute of Medical Sciences and Research Centre
      • Contact: Dr Pankaj Jadon, MBBS MD; Phone Number: +919799902222; Email: Drpankaj.medicine@jnujaipur.ac.in
  • Ravindrapuri Varanasi
    • New Colony, Ravindrapuri Varanasi, India, 221005
      • Recruiting
      • Samvedna Hospital
      • Contact: Dr. Hemant Kumar Gupta, MBBS, MD; Phone Number: +919310246832; Email: Hemantkrg26@gmail.com
  • Telangana
    • Hyderabad, Telangana, India, 500004
      • Recruiting
      • Gleneagles Global Hospitals
      • Contact: Dr.Sameer Kumar, MBBS DNB; Phone Number: +918860031692; Email: sameerzidane@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

• Written and signed informed consent (will be obtained before any study-related Assessments).
• Male or female aged ≥18 - 70 years at the time of consent.

• Female individuals of childbearing potential (Females who are peri or post-menopausal, i.e., when there has been no or irregular menstruation for a minimum of 12 months prior to screening, are considered not to be of child-bearing potential.), who are not surgically sterilized, must have a negative pregnancy test at screening and be willing to practice one of the following appropriate contraceptive methods until:

  • Sexual abstinence.
  • Oral contraceptives.
  • Trans-dermal patches or depot
  • injection of a progestogen drug (starting at least 4 weeks prior to product administration).
  • Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent.
  • Intrauterine device (IUD), intrauterine system (IUS), subdermal implant, or vaginal ring (placed at least 4 weeks prior to product administration/2 weeks prior screening).
  • Contraceptives must be effective before the randomization visit.
• Individuals with plasma FBG (fasting blood glucose) (less than equal to 125 mg/dl).
• Individuals with Hemoglobin (Hb%) (more than equal to 10 g/dl).
• Individuals with BP (blood pressure) (less than equal to 140/100 mm Hg)
• Individuals with normal haematology as assessed by CBC (complete blood counts)
• Individuals with TSH levels in between 0.4 mIU/L to 5.0 mIU/L
• Individuals with SGOT and SGPT within 2 X the Upper normal limit (ULN) and serum
• Individuals with creatinine within 1.5 X ULN

• Rome-IV diagnostic criteria: Individuals with more than 25% of bowel movements with Bristol stool types 1, 2 or 6,7 and have had recurrent abdominal pain, on average, at least 1 day/week in the last 3 months. And the pain is associated with two or more of the following criteria:

  • Related to defecation
  • Associated with a change in frequency of stool
  • Associated with a change in form or appearance of stool as
  • assessed by Bristol stool types 1,2, 6 or 7.
  • Individuals meeting the above criteria for the last 3 months with
  • symptom onset at least 6 months before diagnosis
• Individuals with Abdominal pain severity (more than equal to 6 on a 11-point scale) at screening and during placebo run-in period.
• Individuals with IBS-SSS of at least 175 points at screening.
• Individuals who are mentally stable as assessed by Perceived Stress Scale (PSS) less than equal to 26 (Low to Moderate stress).
• Individuals who understand the nature and purpose of the study including the potential risks and side effects.
• Individuals who are willing to complete all study procedures including study-related questionnaires and comply with study requirements.
• Individuals who are capable of filling the app-based digital form/diary.

Exclusion Criteria:

• 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.
• Individuals with diarrhoea of any other origin.
• Individuals currently or in future planning to fast for more than 24 hours.
• Individuals with an active eating disorder.
• Individuals who have used an over-the-counter or prescription laxative medication or any other herbal agents affecting GI motility within 2 weeks prior to screening.
• Individuals who have used pre/pro/post/synbiotic, Human Milk Oligosaccharides (HMOs), or fiber supplements (or probiotic/fiber enriched foods) or FODMAP diet or an antibiotic within 4 weeks prior to screening.
• Individuals who have used IBS specific treatments within 4 weeks prior to screening.
• Individuals who currently consume greater than 2 standard alcoholic drinks per day from past 3 months. ((One unit of alcohol is equal to 45 ml of hard liquor, 150 ml of wine or a pint of beer)
• Smokers (in any number and any format)
• Individuals with an allergy or sensitivity to the probiotic products.
• Individuals who are cognitively impaired and/or who are unable to give an informed consent.
• Individuals who have abnormal laboratory results or any other medical or psychological condition which, in the opinion of the qualified investigator, may adversely affect the Individuals' ability to complete the study or its measures or which may pose significant risk to the individual.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MIX 1; Humiome® Post LB postbiotic 300 mg , Human Milk Oligosaccharides 2'-O-fucosyllactose 300 mg 1 capsule per day orally	Dietary supplement: MIX 1; Humiome® Post LB postbiotic 300 mg , Human Milk Oligosaccharides 2'-Ofucosyllactose 300 mg 1 capsule per day Orally
Active Comparator: MIX 2; Humiome® Post LB postbiotic 100 mg Human Milk Oligosaccharides 2'-O-fucosyllactose 500 mg 1 capsule per day orally	Dietary supplement: MIX 2; Humiome® Post LB postbiotic 100 mg Human Milk Oligosaccharides 2'-O-fucosyllactose 500 mg 1 capsule per day Orally
Placebo Comparator: Placebo; Microcrystalline 1 capsule per day orally	Dietary supplement: Placebo; Microcrystalline cellulose 1 capsule per day Orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 21. The change in the average IBS severity score will be calculated and compared to the placebo group.	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	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 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	Decrease in Abdominal pain severity as assessed by APS-NRS (Abdominal pain severity - Numeric rating scale)	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)	In gastroenterology, stool consistency is commonly measured using the Bristol Stool Form Scale (BSFS), which categorizes stool into seven types, from type 1 (hard lumps) to type 7 (watery diarrhea). It is a simple, cost-effective tool used as a marker for intestinal transit time and bowel function. In this study, stool consistency will be assessed using the BSFS.	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	The quality of life will be assessed using the IBS-QOL scale. The participants will be asked to score based on their symptoms in the last month at day 0, day 21, and day 42.	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 decreased Abdominal bloating as assessed by Gastrointestinal Quality of Life	The Gastrointestinal Quality of Life Index (GIQLI) is a validated 36-item tool for assessing health-related quality of life across five domains: core symptoms (10 items), physical (6 items), psychological (6 items), social (2 items), and disease-specific (8 items). Each item uses a 0-4 Likert scale, with higher scores indicating better quality of life. Total scores range from 0 to 144, where higher scores reflect improved quality of life.	day 0, day 21, and day 42
To assess the efficacy on Increased percentage of responders to the treatment based on improvement on primary objective. The IBS-SSS is responsive to treatment; therefore, it has been used as a valid tool for performing responder analysis in IBS studies.	The number of responders will be calculated separately for the two definitions given below in the present study: 50 points change in IBS-SSS total score from baseline.; 95 points change in IBS-SSS total score from baseline.	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 daily number of stool sample	Will be assessed by Reduced Daily number of stools (stool frequency, assessed per IBS sub-type	Daily from start of the study to Week 6
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 Absolute difference in rescue medication consumption in active and placebo groups.	Reduced Absolute difference in rescue medication consumption	Daily from start of the study to Week 6
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 Subjective global assessment of IP tolerability by participants.	Will be measured by subjective global assessment of IP tolerability by participants	Daily from start of the study to Week 6
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-related mental stress relief	Will be measured by Perceived stress scale (PSS)	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 on Gut Permeability assessment (Lactulose to Mannitol ratio test) [to be conducted in 30 participants in each arm]	Will be measured by measuring the decrease in Lactulose Mannitol ratio (30 Participants per arm)	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 Stool pH & redox [to be conducted in 30 participants in each arm]	Improved Stool pH (5.5 to 7.0) & decreased redox potential of stool [to be conducted in those participants who are undergoing LMR in each arm	Day 0 and day 42

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Improved Microbiome composition (i.e., increased in beneficial bifidobacteria) (on a selection of samples) will be analyzed using full shotgun sequencing (Illumina Hiseq 150 x2). This will be done on selection of samples	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	Improved microbiome diversity (alpha and beta) will be analyzed (on a selection of samples) using full shotgun sequencing (Illumina Hiseq 150 x2) This will be done on selection of samples	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	Other fecal metabolites will be analysed for improvement (on a selection of samples) by an untargeted metabolomics approach using (semi-polar LC-MS/MS method. This will be done on selection of samples	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 Changes in organic acids in fecal samples compared to baseline, each other and placebo	Improvement in fecal organic acids (acetate, propionate, butyrate, valerate, lactate) as analyzed (on a selection of samples) by a targeted quantitative SCFA method (GC-MS). This will be done on selection of samples	day 0 and day 42

Collaborators and Investigators

• Sponsor: dsm-firmenich Switzerland AG
• Investigators: Study Director: Mehdi Sadaghian, PhD, dsm-firmenich Switzerland AG

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: February 20, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 21, 2025

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Dietary supplement IBS
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome
• Other Study ID Numbers: 2023-08-14-DORP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No