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

NCT ID: NCT02875847

Last Updated: 2018-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-07-31

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HMO1

Daily bolus of HMO1

Group Type: ACTIVE_COMPARATOR

HMO1

Intervention Type: DIETARY_SUPPLEMENT

HMO2

Daily bolus of HMO2

Group Type: ACTIVE_COMPARATOR

HMO2

Intervention Type: DIETARY_SUPPLEMENT

Dextropur

Daily bolus of dextropur

Group Type: PLACEBO_COMPARATOR

Dextropur

Intervention Type: DIETARY_SUPPLEMENT

Interventions

HMO1

Intervention Type: DIETARY_SUPPLEMENT

HMO2

Intervention Type: DIETARY_SUPPLEMENT

Dextropur

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Signed written informed consent

2. Age between 18 and 75 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

• lactose intolerance
• coeliac disease

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

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

5. 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.

6. 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.

7. 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.

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

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahlgrenska University Hospital

OTHER

Sponsor Role: collaborator

Glycom A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Magnus Simrén, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine

Hans Törnblom, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine

Lena Öhman, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine

Locations

SU Sahlgrenska, Department of Internal Medicine

Gothenburg, , Sweden

Countries

Sweden

References

Iribarren C, Tornblom H, Aziz I, Magnusson MK, Sundin J, Vigsnaes LK, Amundsen ID, McConnell B, Seitzberg D, Ohman L, Simren M. Human milk oligosaccharide supplementation in irritable bowel syndrome patients: A parallel, randomized, double-blind, placebo-controlled study. Neurogastroenterol Motil. 2020 Oct;32(10):e13920. doi: 10.1111/nmo.13920. Epub 2020 Jun 14.

Reference Type: DERIVED

PMID: 32536023 (View on PubMed)

Other Identifiers

Dnr: 548-16

Identifier Type: OTHER

Identifier Source: secondary_id

NATRIBS

Identifier Type: -

Identifier Source: org_study_id