The Effect of Two Probiotic Products on the Intestinal Barrier Function in Patients With Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Change in small intestinal permeability after 6 weeks (urinary lactulose/rhamnose ratio, 0-5h)
研究概览
简要总结
This study will investigate the effects of supplementation with two different probiotic products (Lactobacillus reuteri strains) on the intestinal barrier function, gut health and stress symptoms in diarrhoea-predominant irritable bowel syndrome (IBS-D) patients.
详细描述
After having given their written informed consent, subjects will complete screening procedures to evaluate their eligibility for the study (visit 1). Study participants will undergo two baseline visits (visits 2 and 3, 3 weeks apart) to account for individual variations, and will then be randomly assigned to 6-week intake of one of two Lactobacillus reuteri strains, or placebo in a ratio of 1:1:1 (stratified by sex). Participants will attend a study visit three weeks into the intervention (visit 4) and at the end of the intervention (visit 5, week 6). The intestinal permeability will be assessed using a standardized multi-sugar test at visit 2, visit 3, visit 4, and at end of intervention (visit 5). Blood, saliva and faecal samples will be collected at visit 2-5. In addition, gastrointestinal symptoms will be recorded at those visits (using Gastrointestinal symptom rating scale-IBS, GSRS-IBS; IBS severity scoring system, IBS- SSS). Quality of life using the 5Q-5D-5L and Hospital Anxiety and Depression Scale (HADS) scores will also be recorded at those visits. In addition, at visit 3 and visit 5, the IBS-Quality of life (IBS-QoL) and the Perceived Stress Scale (PSS) will be completed. In a daily diary, participants will record stool frequency and consistency from visit 2 until end-of-study visit 5. Dietary habits of the patients will be assessed via a food frequency questionnaire (FFQ) and a 3-day food diary before the intervention (between visit 2 and 3).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Fulfilled Rome IV diagnostic criteria for IBS with predominant diarrhoea
- •Mild-to-severe IBS symptoms according to the IBS severity scoring system (IBS-SSS; a score of ≥75)
- •Age: 18-65 years
排除标准
- •Known organic gastrointestinal disease (e.g. inflammatory bowel disease, IBD)
- •Previous abdominal surgery which might influence gastrointestinal function, except appendectomy and cholecystectomy
- •History of or present gastrointestinal malignancy or polyposis
- •Recently (within the last 6 months) diagnosed gastrointestinal infection
- •Current diagnosis of dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
- •Chronic neurological/neurodegenerative diseases (e.g. Parkinson's disease, multiple sclerosis)
- •Autoimmune disease and/or patients receiving immunosuppressive medications
- •Chronic pain syndromes (e.g. fibromyalgia)
- •Chronic fatigue syndrome
- •Severe endometriosis
- •Coeliac disease
- •Recently (within the last 3 months) diagnosed lactose intolerance
- •Females who are pregnant or breast-feeding
- •Regular intake of systemic corticosteroids and anti-inflammatory medication (including non-steroidal anti-inflammatory drugs, NSAIDs) during the last 3 months or incidental use in the last 2 weeks prior to randomisation
- •Recent (< 4 weeks) intake of proton pump inhibitors, PPIs (e.g., omeprazol)
- •Use of anti-depressants in the last 3 months
- •Regular oral intake of mast cell stabilising drugs (e.g. sodium cromoglycate) during the last 3 months or incidental use in the last 2 weeks prior to screening
- •Antimicrobial treatment 6 weeks prior to first screening visit
- •Antimicrobial prophylaxis (eg. acne, urinary tract infection)
- •Regular consumption of probiotic products 4 weeks prior to first baseline visit
- •Concurrent or recent (<4 weeks) use of nutritional supplements or herb products affecting intestinal function (e.g. aloe vera, St. John´s Wort, fibres, prebiotics) if the investigator considers those could affect the study outcome.
- •Inability to maintain exercise routine and dietary pattern during the study.
- •Abuse of alcohol or drugs
- •Any clinically significant present or past disease/condition which in the investigator's opinion could interfere with the results of the trial
结局指标
主要结局
Change in small intestinal permeability after 6 weeks (urinary lactulose/rhamnose ratio, 0-5h)
时间窗: 6 weeks
Difference in small intestinal permeability, measured as the urinary lactulose/rhamnose secretion ratio (0-5h), after a 6-week intervention with the probiotic products compared to the placebo product
次要结局
- Change in whole gut permeability after 6 weeks (urinary sucralose/erythritol ratio, 0-24h)(6 weeks)
- Change in whole gut permeability after 3 weeks (urinary sucralose/erythritol excretion ratio, 0-24h)(3 weeks)
- Change in colonic permeability after 6 weeks (urinary sucralose/erythritol ratio, 5-24h)(6 weeks)
- Change in small intestinal permeability after 3 weeks (urinary lactulose/rhamnose ratio, 0-5h)(3 weeks)
- Change in gastroduodenal permeability after 3 weeks (urinary sucrose excretion, 0-5hrs)(3 weeks)
- Change in inflammatory status after 3 weeks(3 weeks)
- Change in colonic permeability after 3 weeks (urinary sucralose/erythritol ratio, 5-24hrs)(3 weeks)
- Change in gastroduodenal permeability after 6 weeks (urinary sucrose excretion, 0-5hrs)(6 weeks)
- Change in inflammatory status after 6 weeks(6 weeks)
研究者
Robert Brummer
Professor, MD, PhD
Örebro University, Sweden