Clinical trial NCT06889779: Study Evaluating the Efficacy of Different Mixes of HMO-2FL + Humiome® Post LB on IBS Gastrointestinal Symptoms
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: IBS (Irritable Bowel Syndrome)
Keywords: Dietary supplement IBS
Lead sponsor: DSM Nutritional Products, Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-21
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment A randomized, placebo-controlled, double-blind
Primary purpose: TREATMENT

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)

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.

Eligibility criteria: * 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.

Primary outcomes:
measure: 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
timeFrame: Day 0 & Day 42
Secondary outcomes:
measure: 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
timeFrame: Day 0, Day 21
measure: 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
timeFrame: Day 0, Day 21 and Day 42
measure: 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
timeFrame: Day 0, Day 21 and Day 42
measure: 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)
timeFrame: Time Frame: Day 0, Day 21 and Day 42
measure: 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
timeFrame: day 0, day 21, and day 42
measure: 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
timeFrame: day 0, day 21, and day 42
measure: 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.
timeFrame: day 0, day 21 and day 42
measure: 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
timeFrame: Daily from start of the study to Week 6
measure: 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.
timeFrame: Daily from start of the study to Week 6
measure: 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.
timeFrame: Daily from start of the study to Week 6
measure: 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
timeFrame: Day 0 and day 42
measure: 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]
timeFrame: Day 0 and day 42
measure: 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]
timeFrame: Day 0 and day 42
Other outcomes:
measure: 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
timeFrame: day 0 and day 42
measure: 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
timeFrame: day 0 and day 42
measure: 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
timeFrame: day 0 and day 42
measure: 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
timeFrame: day 0 and day 42
Locations:
city: Bijapur
country: India
facility: Shri. B. M. PatilMedical College,Hospital andResearch Centre
state: Karanataka
city: Belgaum
country: India
facility: BHS Lakeview Hospital Belgaum
state: Karnataka
city: Dombivali
country: India
facility: Shivam Hospital
state: Maharashtra
city: Kalyān
country: India
facility: Jeevan Clinic
state: Maharashtra
city: Kolhapur
country: India
facility: Aster Aadhar Hospital
state: Maharashtra
city: Mumbai
country: India
facility: Haut Diabetes Care
state: Maharashtra
city: Nashik
country: India
facility: Soham Hospital
state: Maharashtra
city: Navi Mumbai
country: India
facility: D Y Patil
state: Maharashtra
city: Pune
country: India
facility: Silver Birch
state: Maharashtra
city: Pune
country: India
facility: Vishwaraj hospital
state: Maharashtra
city: Jaipur,
country: India
facility: Jaipur National University Institute of Medical Sciences and Research Centre
state: Rajasthan
city: Hyderabad
country: India
facility: Gleneagles Global Hospitals
state: Telangana
Study officials:
affiliation: DSM Nutritional Products, Inc.
name: Mehdi Sadaghian, PhD
role: STUDY_DIRECTOR
References: