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Completed

NCT Number: NCT05475314

Effect of Postbiotic Product on Colonic Barriers in IBS

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linköping University Hospital, Linköping, Sweden

Linköping, 58185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ReFerm(R)

Dietary Supplement

Enemas of approx 250 mL twice daily

Other names: Profermin(R)

Primary outcomes

  1. 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

  1. Symptom change

    Time frame: 14 days

    Symptom change using the following questionnaires systems.

    IBS severity scoring system for symptom change (significant if > 50 points) before and after treatment.

    Gastrointestinal Symptom Rating Scale-IBS and Visceral sensitivity index. Data analyzed by cluster or as a total score for all items with statistically significant change.

    Hospital Anxiety and Depression Scale. Cut-off values are indicated as ≥8 for subclinical (suspicious) anxiety or depression and ≥11 as definite cases on both the HADS-D and HADS-A, respectively.

    Short Health Scale. Data analyzed by cluster or as a total score for all items with statistically significant change.

Sponsors and collaborators

Lead sponsor

Nordisk Rebalance A/S

Industry

Collaborators

  • Linkoeping University
  • University Hospital, Linkoeping

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 26, 2022
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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