Effect of Postbiotic Product on Colonic Barriers in IBS

NCT05475314 | Completed

• 1 other identifier: referm-barrier
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

IBS - Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Symptom change

  14 days

Study Arms (2)

ReFerm(R); fermented oat gruel

EXPERIMENTAL

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

Dietary Supplement: ReFerm(R)

Thick-it(R); thickened water

PLACEBO COMPARATOR

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

Dietary Supplement: ReFerm(R)

Interventions

ReFerm(R) DIETARY_SUPPLEMENT

Enemas of approx 250 mL twice daily

Also known as: Profermin(R)

ReFerm(R); fermented oat gruel; Thick-it(R); thickened water

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nordisk Rebalance A/S: lead
• University Hospital, Linkoeping: collaborator
• Linkoeping University: collaborator

Study Sites (1)

Linköping University Hospital, Linköping, Sweden

Linköping, 58185, Sweden

Location

Related Publications (2)

• 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.

  PMID: 39026547 DERIVED

• 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.

  PMID: 36570171 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Susanna Walter, MD

  University Hospital, Linköping, Sweden

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The appearance including colour and thickness of the two products are similar
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 26, 2022
• Study Start: December 1, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2022
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)