Clinical trial NCT05475314: Effect of Postbiotic Product on Colonic Barriers in IBS
Official title: A Postbiotic Fermented Oat Gruel May Have a Beneficial Effect on the Colonic Mucosal Barrier in Patients With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IBS - Irritable Bowel Syndrome
Lead sponsor: Nordisk Rebalance A/S
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Linkoeping
name: Linkoeping University
First posted: 2022-07-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were randomly allocated to ReFerm® (18 patients, two men) or placebo (12 patients, three men) arms. There were no significant differences between the groups in terms of age, BMI, or disease severity.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intestinal permeability
timeFrame: 14 days
Secondary outcomes:
measure: Symptom change
timeFrame: 14 days
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University Hospital, Linköping, Sweden
Study officials:
affiliation: University Hospital, Linköping, Sweden
name: Susanna Walter, MD
role: STUDY_CHAIR
References: