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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

402 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-27

Study Completion Date

2026-03-15

Brief Summary

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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)

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Detailed Description

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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

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IBS (Irritable Bowel Syndrome)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment A randomized, placebo-controlled, double-blind

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MIX 1

Humiome® Post LB postbiotic 300 mg , Human Milk Oligosaccharides 2'-O-fucosyllactose 300 mg 1 capsule per day orally

Group Type ACTIVE_COMPARATOR