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Effects of HMOs on Faecal Microbiota, Gastrointestinal Symptoms, Mucosal Immunity and Barrier Function in IBS Patients

NCT02875847 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-09-24

No results posted yet for this study

Summary

The study is a randomised, placebo-controlled, double-blind parallel study in IBS patients. A total of 60 adult patients diagnosed with IBS-C, -D or -A/M according to Rome IV criteria will be included. The participants will be randomized into one of three groups consuming either HMO (two groups) or placebo (one group).

The primary objective of the study is to establish the effect of HMOs on the faecal microbiota in IBS patients. Secondary objectives are to assess the effect on gastrointestinal symptoms, mucosal immunity, gut barrier function, quality of life, and anxiety and depression.

Conditions

  • Irritable Bowel Syndrome (IBS)

Interventions

DIETARY_SUPPLEMENT

HMO1

DIETARY_SUPPLEMENT

HMO2

DIETARY_SUPPLEMENT

Dextropur

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Glycom A/S

    lead INDUSTRY

Principal Investigators

  • Magnus Simrén, MD, PhD · Department of Internal Medicine

  • Hans Törnblom, MD, PhD · Department of Internal Medicine

  • Lena Öhman, PhD · Department of Internal Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02875847 on ClinicalTrials.gov