CTRI/2025/03/082463
Recruiting
Not Applicable
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)
DSM Firmenich Switzerland Ltd19 sites in 1 country330 target enrollmentStarted: March 29, 2025Last updated:
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- DSM Firmenich Switzerland Ltd
- Enrollment
- 330
- Locations
- 19
- Primary Endpoint
- 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 in individuals with IBS
Overview
Brief Summary
The present study is a randomized, double-blind, placebo-controlled, parallel group three arm study. The intervention duration for all the study participants is 6 weeks
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Written informed consent will be obtained before any study-related assessments 2.Male or female aged less than or equal to 18 to 70 years at the time of consent 3.Female individuals of childbearing potential (Females who are peri or post-menopausal ,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 the last visit i.Sexual abstinence ii.Oral contraceptives.
- •iii.Trans-dermal patches or depot injection of a progestogen drug (starting at least 4 weeks prior to product administration).
- •iv.Double barrier method: condom or occlusive cap plus spermicidal agent.
- •Intrauterine device intrauterine system 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 4.Individuals with Plasma FBG (fasting blood glucose) (less than equal to 125 mg/dl).
- •5.Individuals with haemoglobin Hb (more than equal to 10 g/dl).
- •6.Individuals with BP (blood pressure) (less than equal to 140/100 mm Hg) 7.Individuals with normal haematology as assessed by CBC (complete blood counts) 8.Individuals with TSH levels in between 0.4 mIU/L and 5.0 mIU/L 9.SGOT and SGPT within 2 X the Upper normal limit (ULN) and serum creatinine within 1.5 X ULN 10.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.
- •The pain is associated with two or more of the following criteria: a.Related to defecation b.Associated with a change in frequency of stool c.Associated with a change in form or appearance of stool as assessed by Bristol stool type 1,2, 6 or 7 11.Abdominal pain severity (more than equal to 6 on a 11-point scale) at screening and during placebo run-in period.
- •12.Individuals with IBS-SSS score of at least 175 points at screening.
- •13.Individuals who are mentally stable as assessed by Perceived stress Scale (PSS) less than equal to 26 (Low to Moderate stress) 14.Individuals who understand the nature and purpose of the study including the potential risks and side effects.
Exclusion Criteria
- •1.Individuals with IBS-M.
- •2.Treatment with an investigational drug within 30 days/5 half-lives of the drug (whichever longest) prior to screening visit.
- •3.Individuals with organic disease like infectious diseases, inflammatory diseases, metabolic disorders, neurological diseases, autoimmune disorders, cancer 4.Individuals with a history of surgical resection of the stomach, small intestine or large intestine.
- •5.Individuals with a history of or complications from inflammatory bowel disease , colitis and enteritis.
- •6.Individuals with a history of any diet-based intolerance (gluten or lactose intolerance).
- •7.Individuals with a history of drug or alcohol abuse within the past 6 months.
- •8.Individuals with severe depression or an anxiety disorder, which could potentially affect the efficacy evaluation (as determined by the qualified investigator).
- •9.Individuals with uncontrolled hypertension or on antihypertensive medications 10.Individuals with serious cardiovascular diseases, respiratory diseases, renal diseases, hepatic diseases, gastrointestinal diseases (excluding IBS), blood diseases or neurological or psychiatric diseases.
- •11.Individuals who are pregnant, breastfeeding or planning on becoming pregnant throughout the course of the study.
- •12.Individuals with Type I or Type II diabetes mellitus.
Outcomes
Primary Outcomes
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 in individuals with IBS
Time Frame: Day 0, and Day 42
Secondary Outcomes
- To assess the efficacy 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 in individuals with IBS(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 the following parameters compared to baseline, each other and placebo in individuals with IBS(1.Abdominal pain severity (11-point scale))
- 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 the following parameters compared to baseline, each other and placebo in individuals with IBS(1.Daily number of stools (stool frequency).)
- 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 the following parameters compared to baseline, each other and placebo in individuals with IBS(1.IBS-related mental stress relief as assessed by the Perceived Stress Scale (PSS))
- 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 the following parameters compared to baseline, each other and placebo in individuals with IBS(1.Change in gut microbiome composition at genus and/ or species level.)
Investigators
Dr Sanjay Vaze
Vedic Lifesciences Pvt Ltd
Study Sites (19)
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