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临床试验/NCT05475314
NCT05475314已完成不适用

A Postbiotic Fermented Oat Gruel May Have a Beneficial Effect on the Colonic Mucosal Barrier in Patients With Irritable Bowel Syndrome

Nordisk Rebalance A/S2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Intestinal permeability

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Care Provider)

盲法说明

The appearance including colour and thickness of the two products are similar

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Intestinal permeability

时间窗: 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

次要结局

  • Symptom change(14 days)

研究者

发起方
Nordisk Rebalance A/S
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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