Effect of Postbiotic Product on Colonic Barriers in IBS

Nordisk Rebalance

Status: Completed

Conditions: IBS - Irritable Bowel Syndrome

Treatments: Dietary Supplement: ReFerm(R)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05475314

referm-barrier

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

ReFerm(R); fermented oat gruel

Experimental group

Description:

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

Treatment:

Dietary Supplement: ReFerm(R)

Thick-it(R); thickened water

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: ReFerm(R)