The Effect of Two Probiotic Products on the Intestinal Barrier Function in Patients With Irritable Bowel Syndrome

NCT03986476 | Completed

• 1 other identifier: 2018/450
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the effects of supplementation with two different probiotic products (Lactobacillus reuteri strains) on the intestinal barrier function, gut health and stress symptoms in diarrhoea-predominant irritable bowel syndrome (IBS-D) patients.

Conditions

IBS

Outcome Measures

Primary Outcomes (1)

• Change in small intestinal permeability after 6 weeks (urinary lactulose/rhamnose ratio, 0-5h)

  Difference in small intestinal permeability, measured as the urinary lactulose/rhamnose secretion ratio (0-5h), after a 6-week intervention with the probiotic products compared to the placebo product

  6 weeks

Secondary Outcomes (9)

• Change in small intestinal permeability after 3 weeks (urinary lactulose/rhamnose ratio, 0-5h)

  3 weeks

• Change in whole gut permeability after 6 weeks (urinary sucralose/erythritol ratio, 0-24h)

  6 weeks

• Change in whole gut permeability after 3 weeks (urinary sucralose/erythritol excretion ratio, 0-24h)

  3 weeks

• Change in colonic permeability after 6 weeks (urinary sucralose/erythritol ratio, 5-24h)

  6 weeks

• Change in colonic permeability after 3 weeks (urinary sucralose/erythritol ratio, 5-24hrs)

  3 weeks

Other Outcomes (20)

• Change in stool frequency and consistency (daily diary on bowel movement using Bristol Stool Chart)

  3 weeks

• Change in stool frequency and consistency (daily diary on bowel movement using Bristol Stool Chart)

  6 weeks

• Change in gastrointestinal symptoms measured by the IBS-specific gastrointestinal symptom rating scale (GSRS-IBS)

  3 weeks

Study Arms (3)

Lactobacillus reuteri strain 1

EXPERIMENTAL

Probiotic compound

Dietary Supplement: Probiotics

Lactobacillus reuteri strain 2

EXPERIMENTAL

Probiotic compound

Dietary Supplement: Probiotics

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Probiotics DIETARY_SUPPLEMENT

5x10\^8 colony forming units (CFU) of each probiotic strain, two capsules per day over six weeks

Lactobacillus reuteri strain 1; Lactobacillus reuteri strain 2

Placebo OTHER

Similar in shape and taste to intervention capsules but without the probiotic components, two capsules per day over six weeks

Placebo

Eligibility Criteria

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

You may qualify if:

• Signed informed consent
• Fulfilled Rome IV diagnostic criteria for IBS with predominant diarrhoea
• Mild-to-severe IBS symptoms according to the IBS severity scoring system (IBS-SSS; a score of ≥75)
• Age: 18-65 years

You may not qualify if:

• Known organic gastrointestinal disease (e.g. inflammatory bowel disease, IBD)
• Previous abdominal surgery which might influence gastrointestinal function, except appendectomy and cholecystectomy
• History of or present gastrointestinal malignancy or polyposis
• Recently (within the last 6 months) diagnosed gastrointestinal infection
• Current diagnosis of dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
• Chronic neurological/neurodegenerative diseases (e.g. Parkinson's disease, multiple sclerosis)
• Autoimmune disease and/or patients receiving immunosuppressive medications
• Chronic pain syndromes (e.g. fibromyalgia)
• Chronic fatigue syndrome
• Severe endometriosis
• Coeliac disease
• Recently (within the last 3 months) diagnosed lactose intolerance
• Females who are pregnant or breast-feeding
• Regular intake of systemic corticosteroids and anti-inflammatory medication (including non-steroidal anti-inflammatory drugs, NSAIDs) during the last 3 months or incidental use in the last 2 weeks prior to randomisation
• Recent (\< 4 weeks) intake of proton pump inhibitors, PPIs (e.g., omeprazol)

Sponsors & Collaborators

• Örebro University, Sweden: lead

Study Sites (1)

Örebro University

Örebro, Örebro County, 70182, Sweden

Location

Related Publications (1)

• Konig J, Roca Rubio MF, Forsgard RA, Rode J, Axelsson J, Grompone G, Brummer RJ. The effects of a 6-week intervention with Limosilactobacillus reuteri ATCC PTA 6475 alone and in combination with L. reuteri DSM 17938 on gut barrier function, immune markers, and symptoms in patients with IBS-D-An exploratory RCT. PLoS One. 2024 Nov 1;19(11):e0312464. doi: 10.1371/journal.pone.0312464. eCollection 2024.

  PMID: 39485760 DERIVED

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Robert J Brummer, MD, PhD

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 14, 2019
• Study Start: March 26, 2019
• Primary Completion: May 10, 2021
• Study Completion: May 10, 2021
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)