Linköping University Hospital, Linköping, Sweden
Linköping, 58185, Sweden
NCT Number: NCT05475314
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Linköping, 58185, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Enemas of approx 250 mL twice daily
Other names: Profermin(R)
Time frame: 14 days
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
Time frame: 14 days
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.
Nordisk Rebalance A/S
Industry
A Postbiotic Fermented Oat Gruel May Have a Beneficial Effect on the Colonic Mucosal Barrier in Patients With Irritable Bowel Syndrome
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