Effect of Postbiotic Product on Colonic Barriers in IBS

NCT ID: NCT05475314

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-04-30

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.

Conditions

IBS - Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

ReFerm(R); fermented oat gruel

ReFerm® is manufactured by the fermentation of an oat gruel with L. plantarum 299v. The product is tested for pH and colony-forming units (CFU) of Enterobacteriaceae, yeasts/moulds, and L. plantarum 299v. The pH must be \< 4.0, the CFU of Enterobacteriaceae and yeasts/moulds must be \< 100/mL, and the CFU for L. plantarum 299v must be \> 10E+08 immediately after completion of fermentation. The energy content of 100 mL ReFerm® is 58 kcal (240 kJ), from 1.6 g protein, 9.8 g carbohydrate, and 0.9 g fat. Each ReFerm® package contained 250 ml

Group Type: EXPERIMENTAL

ReFerm(R)

Intervention Type: DIETARY_SUPPLEMENT

Enemas of approx 250 mL twice daily

Thick-it(R); thickened water

Thick-it ® mildly thick, Kent Precision Foods Group, Inc.; commercially available) was chosen as a placebo to mimic the viscosity. This product contains artesian mineral water and ≤ 2% xanthan gum, calcium chloride, malic acid, potassium benzoate, potassium sorbate (to preserve freshness), sodium hexametaphosphate, and disodium EDTA. The energy content of 237 mL Thick-it ® (one package) was 5 kcal (21 kJ) from 0 g protein, 1 g carbohydrate, and 0 g fat

Group Type: PLACEBO_COMPARATOR

ReFerm(R)

Intervention Type: DIETARY_SUPPLEMENT

Enemas of approx 250 mL twice daily

Interventions

ReFerm(R)

Enemas of approx 250 mL twice daily

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Profermin(R)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Linkoeping

OTHER

Sponsor Role: collaborator

Linkoeping University

OTHER_GOV

Sponsor Role: collaborator

Nordisk Rebalance A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susanna Walter, MD

Role: STUDY_CHAIR

University Hospital, Linköping, Sweden

Locations

Linköping University Hospital, Linköping, Sweden

Linköping, , Sweden

Countries

Sweden

References

Biskou O, Walter S, Israelsen H, Winberg ME, Bednarska O, Keita AV. ReFerm(R): a postbiotic fermented oat gruel composition is reducing mast cell degranulation in the colon of patients with irritable bowel syndrome. Front Med (Lausanne). 2024 Jul 4;11:1408623. doi: 10.3389/fmed.2024.1408623. eCollection 2024.

Reference Type: DERIVED

PMID: 39026547 (View on PubMed)

Bednarska O, Biskou O, Israelsen H, Winberg ME, Walter S, Keita AV. A postbiotic fermented oat gruel may have a beneficial effect on the colonic mucosal barrier in patients with irritable bowel syndrome. Front Nutr. 2022 Dec 8;9:1004084. doi: 10.3389/fnut.2022.1004084. eCollection 2022.

Reference Type: DERIVED

PMID: 36570171 (View on PubMed)

Other Identifiers

referm-barrier

Identifier Type: -

Identifier Source: org_study_id