Effect of Postbiotic Product on Colonic Barriers in IBS

Last updated: July 25, 2022
Sponsor: Nordisk Rebalance A/S
Overall Status: Completed

Phase

N/A

Condition

Gastrointestinal Diseases And Disorders

Colic

Lactose Intolerance

Treatment

N/A

Clinical Study ID

NCT05475314
referm-barrier
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

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

Study Design

Total Participants: 30
Study Start date:
December 01, 2020
Estimated Completion Date:
April 30, 2022

Study 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.

Connect with a study center

  • Linköping University Hospital, Linköping, Sweden

    Linköping, 58185
    Sweden

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.