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

NCT02875847 | Completed Phase 2

• 2 other identifiers: NATRIBSDnr: 548-16
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• Change from baseline in intestinal bifidobacteria abundance

  Baseline and after 4 weeks of intake

Secondary Outcomes (13)

• Change from baseline of faecal microbiota profile

  Baseline and after 4 weeks of intake, and after 4 weeks of wash-out

• Change from baseline of IBS symptoms as measured via the total score on the IBS Symptoms Severity Scale (IBS-SSS) and the proportion of responders in all patients and subgroup of patients

  Baseline and after 4 weeks of intake, and after 4 weeks of wash-out

• Change from baseline of intensity of abdominal pain and number of days of abdominal pain as measured on the 11 point Numeric Rating Scale (NRS-11) in all patients and subgroups of patients

  Baseline and after 4 weeks of intake, and after 4 weeks of wash-out

• Change from baseline of bowel habits as measured via the IBS-SSS, the Bristol Stool Form Scale (BSFS) and a bowel movement diary in all patients and subgroup of patients

  Baseline and after 4 weeks of intake, and after 4 weeks of wash-out

• Change from baseline of abdominal distention as measured via the IBS-SSS in all patients and subgroups of patients

  Baseline and after 4 weeks of intake, and after 4 weeks of wash-out

Study Arms (3)

HMO1

ACTIVE COMPARATOR

Daily bolus of HMO1

Dietary Supplement: HMO1

HMO2

ACTIVE COMPARATOR

Daily bolus of HMO2

Dietary Supplement: HMO2

Dextropur

PLACEBO COMPARATOR

Daily bolus of dextropur

Dietary Supplement: Dextropur

Interventions

HMO1 DIETARY_SUPPLEMENT

HMO1

HMO2 DIETARY_SUPPLEMENT

HMO2

Dextropur DIETARY_SUPPLEMENT

Dextropur

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent
• Age between 18 and 75 years at visit 2
• Fulfills definition of IBS-D, IBS-C or IBS-A/M according to Rome IV criteria
• Have a global IBS-SSS score of \>174 during the 2 weeks run-in period
• Read, speak and understand Swedish
• Ability and willingness to understand and comply with the study procedures

You may not qualify if:

• Participation in a clinical intervention trial one month prior to screening visit and throughout the study.
• 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
• Other severe disease(s) such as malignancy, diabetes, severe coronary disease, kidney disease or neurological disease, as judged by the investigator.
• Severe psychiatric disease and/or psychological disturbance, as judged by the investigator.
• 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.
• 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.
• 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.
• Diagnosed with and treated for IBS for more than 10 years
• Pregnant or lactating or wish to become pregnant during the period of the study.
• Lack of suitability for participation in the study for any reason as judged by the investigator.

Sponsors & Collaborators

• Glycom A/S: lead
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

SU Sahlgrenska, Department of Internal Medicine

Gothenburg, SE-413 35, Sweden

Location

Related Publications (1)

• 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.

  PMID: 32536023 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Magnus Simrén, MD, PhD

  Department of Internal Medicine

  PRINCIPAL INVESTIGATOR

• Hans Törnblom, MD, PhD

  Department of Internal Medicine

  PRINCIPAL INVESTIGATOR

• Lena Öhman, PhD

  Department of Internal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 23, 2016
• Study Start: September 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 24, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)