Ignite Creation Date:
2024-05-06 @ 5:54 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05475314
Status:
COMPLETED
Last Update Posted:
2022-07-26
First Post:
2022-07-21
Brief Title:
Effect of Postbiotic Product on Colonic Barriers in IBS
Sponsor:
Nordisk Rebalance AS
Organization:
Nordisk Rebalance AS
Study Overview
Official Title:
A Postbiotic Fermented Oat Gruel May Have a Beneficial Effect on the Colonic Mucosal Barrier in Patients With Irritable Bowel Syndrome
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None