Clinical Trial Details

NCT ID: NCT02875847
Date Last Changed: June 20, 2017

Overview

Research Study Summary

A Phase 2 clinical study for patients with Irritable Bowel Syndrome (IBS)

Research Study Title

The Effects of Human Milk Oligosaccharides on Faecal Microbiota, Gastrointestinal Symptoms, Mucosal Immunity and Barrier Function in Irritable Bowel Syndrome: a Parellell, Double-blind, Randomised, Placebo-controlled Study

Purpose

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.

To Learn more

Recruitment Details

Phase
2
Gender
All
Age
18 to 60 Years
Overall Status
Recruiting
Lead Sponsor
Glycom A/S
Duration
12 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years to 60 Years

Inclusion Criteria:

  1. Signed written informed consent

  2. Age between 18 and 60 years at visit 2

  3. Fulfills definition of IBS-D, IBS-C or IBS-A/M according to Rome IV criteria

  4. Have a global IBS-SSS score of > 174 during the 2 weeks run-in period

  5. Read, speak and understand Swedish

  6. Ability and willingness to understand and comply with the study procedures

Exclusion Criteria:

  1. Participation in a clinical intervention trial one month prior to screening visit and throughout the study.

  2. Any known gastrointestinal disease(s) that may cause symptoms or may interfere with the trial outcome, as judged by the investigator; in particular

  3. lactose intolerance

  4. coeliac disease

  5. Other severe disease(s) such as malignancy, diabetes, severe coronary disease, kidney disease or neurological disease, as judged by the investigator.

  6. Severe psychiatric disease and/or psychological disturbance, as judged by the investigator.

  7. Use of highly dosed probiotic supplements (yoghurt allowed) one month prior to the study and throughout the study. Excluded products are (i) probiotic supplements in the form of capsules, tablets, and powders in sachets, and (ii) probiotic food and drink products which contain high doses of probiotics. The excluded food and drink products are available in the form of yoghurts, drinking yoghurts, shots and drinks under brands such as Proviva, Actimel, Activia, Wellness, and Verum.

  8. Consumption of antibiotic drugs one month prior to screening and throughout the study. Antibiotic use within the last three months prior to screening will be registered.

  9. Consumption on a regular basis of medication that might interfere with symptom evaluation (as judged by the investigator) two weeks prior to screening and throughout the study. Specifically excluded drugs are opioids, NSAIDs on a weekly basis, regular use of laxatives and anti-diarrhoeal drugs, any drugs indicated for IBS symptoms.

  10. Diagnosed with and treated for IBS for more than 10 years

  11. Pregnant or lactating or wish to become pregnant during the period of the study.

  12. Lack of suitability for participation in the study for any reason as judged by the investigator.

Site Locations (1)

Country State City Zip Facility and Contact
Sweden Göteborg SE-413 35 SU Sahlgrenska, Department of Internal Medicine
Magnus Simrén, MD, PhD
magnus.simren@medicine.gu.se

Contact

Emma Elison, PhD

E-mail:

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