NCT06889779

Study Evaluating the Efficacy of Different Mixes of HMO-2FL + Humiome® Post LB on IBS Gastrointestinal Symptoms

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 402 (estimated)
• Sponsor: dsm-firmenich Switzerland AG · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• IBS (Irritable Bowel Syndrome)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	MIX 1	Humiome® Post LB postbiotic 300 mg , Human Milk Oligosaccharides 2'-Ofucosyllactose 300 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
DIETARY_SUPPLEMENT	Placebo	Microcrystalline cellulose 1 capsule per day Orally

Timeline

• Start date: 2025-03-27
• Primary completion: 2026-05-30
• Completion: 2026-07-30
• First posted: 2025-03-21
• Last updated: 2026-03-11

Locations

12 sites across 1 country: India