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

Glycom

Status and phase: Completed; Phase 2

Conditions: Irritable Bowel Syndrome (IBS)

Treatments: Dietary Supplement: Dextropur; Dietary Supplement: HMO2; Dietary Supplement: HMO1

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02875847

NATRIBS

Dnr: 548-16 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

HMO1

Active Comparator group

Description:

Daily bolus of HMO1

Treatment:

Dietary Supplement: HMO1

HMO2

Active Comparator group

Description:

Daily bolus of HMO2

Treatment:

Dietary Supplement: HMO2

Dextropur

Placebo Comparator group

Description:

Daily bolus of dextropur

Treatment:

Dietary Supplement: Dextropur