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)
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
402
Humiome® Post LB postbiotic 300 mg , Human Milk Oligosaccharides 2'-Ofucosyllactose 300 mg 1 capsule per day Orally
Humiome® Post LB postbiotic 100 mg Human Milk Oligosaccharides 2'-O-fucosyllactose 500 mg 1 capsule per day Orally
Microcrystalline cellulose 1 capsule per day Orally
Shri. B. M. PatilMedical College,Hospital andResearch Centre
Vijayapura, Karnataka, India
RECRUITINGShivam Hospital
Dombivali, Maharashtra, India
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.
Time frame: Day 0 & Day 42
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.
Time frame: 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.
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 (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)
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Aster Aadhar Hospital
Kolhāpur, Maharashtra, India
RECRUITINGD Y Patil
Navi Mumbai, Maharashtra, India
RECRUITINGDhanwantari Hospital
Pune, Maharashtra, India
RECRUITINGSilver Birch
Pune, Maharashtra, India
RECRUITINGVishwaraj hospital
Pune, Maharashtra, India
RECRUITINGD Y Patil Hospital, Medical college and research centre
Thane, Maharashtra, India
RECRUITINGDr. Naresh Bansal's Gastro & Liver Clinic
New Delhi, National Capital Territory of Delhi, India
RECRUITINGJaipur National University Institute of Medical Sciences and Research Centre
Jaipur, Rajasthan, India
RECRUITING...and 2 more locations
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 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: 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.
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 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.
Time frame: 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: 1. 50 points change in IBS-SSS total score from baseline. 2. 95 points change in IBS-SSS total score from baseline.
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 (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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Day 0 and day 42