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Clinical Trials/NCT05475314
NCT05475314CompletedNot Applicable

A Postbiotic Fermented Oat Gruel May Have a Beneficial Effect on the Colonic Mucosal Barrier in Patients With Irritable Bowel Syndrome

Nordisk Rebalance A/S2 sites in 1 country30 target enrollmentStarted: December 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
2
Primary Endpoint
Intestinal permeability

Study Overview

Brief Summary

Impaired intestinal permeability and microbial dysbiosis are important pathophysiological mechanisms underlying irritable bowel syndrome (IBS). ReFerm®, also called Profermin®, is a postbiotic product of oat gruel fermented with Lactobacillus plantarum 299v. In this experimental study, we investigated whether ReFerm® has a beneficial effect on the intestinal epithelial barrier function in patients with IBS.

Detailed Description

A single-blinded, randomised experimental study was conducted. Potential participants were screened based on the inclusion and exclusion criteria during telephone interviews. As the patients were their own controls, self-reported allergy was not an exclusion criterion as long as both interventions were carried out during unchanged allergic exposure.

Patients were then randomly allocated to one of two study arms: Referm® or thickened water (Thick-it ®, commercially available; Kent Precision Foods Group, Inc., Muscatine, IA, USA) as placebo. The patients underwent sigmoidoscopy with biopsies obtained from the distal colon at baseline and after 14 days of intervention with ReFerm® or placebo enema twice a day. The enema was administered rectally, in the left side position, and retained for as long as possible (at least 10 min) both in the left-sided and supine body position to activate retrograde peristalsis. To assess clinical improvement of symptoms, questionnaires were completed twice: before and after the intervention. During the 14 days of the intervention, the patients completed daily questionnaires. To improve compliance with the study intervention, the patients were given a check-up call by a principal investigator (OBe) twice per week during the intervention period.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Double (Participant, Care Provider)

Masking Description

The appearance including colour and thickness of the two products are similar

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Confirmed IBS-D or IBS-M according to Rome IV criteria
  • Moderate to severe IBS according to IBS-SSS score (≥175p)
  • Age 18-70 years
  • Fluency in written and spoken Swedish language

Exclusion Criteria

  • Organic gastrointestinal disease
  • Previous major gastrointestinal operation (apart from appendectomy and cholecystectomy)
  • Psychiatric disease (bipolar disease, schizophrenia)
  • NSAID intake less than 2 weeks prior to endoscopy
  • Self-reported pregnancy

Outcomes

Primary Outcomes

Intestinal permeability

Time Frame: 14 days

Basic Science. Mucosal permeability change (transcellular (amount of HRP (fmol/mL) and paracellular (amount of FITC (pM)), before and after treatment using an Ussing chamber with mounted patient biopsies

Secondary Outcomes

  • Symptom change(14 days)

Investigators

Sponsor
Nordisk Rebalance A/S
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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