Effect of Postbiotic Product on Colonic Barriers in IBS

IBS - Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05475314
• Other study ID #: referm-barrier
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: July 2022
• Source: Nordisk Rebalance A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• IBS - Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• ReFerm(R)
Enemas of approx 250 mL twice daily

Locations

Country	Name	City	State
Sweden	Linköping University Hospital, Linköping, Sweden	Linköping

Sponsors (3)

Lead Sponsor	Collaborator
Nordisk Rebalance A/S	Linkoeping University, University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intestinal permeability	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	14 days
Secondary	Symptom change	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.	14 days