Effect of Lactobacillus Casei dg (Enterolactis Plus®) in Patient With Irritable Bowel Syndrome: Multicenter, Randomized, Double-blind, Cross-over, Placebo Controlled, Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 8
- 主要终点
- Consumption of rescue medication
研究概览
简要总结
The aim of the study is to collect data for the assessment of the Lactobacillus casei DG (Enterolactis plus®) effect on overall abdominal pain/discomfort, symptoms and gut microbiota composition in patients with Irritable Bowel Syndrome.
详细描述
The aim of the study is to collect data for the assessment of the Lactobacillus casei DG (Enterolactis plus®) effect on overall abdominal pain/discomfort, symptoms and gut microbiota composition in patients with Irritable Bowel Syndrome. The investigators suppose that, due to the immunomodulatory action of probiotics, overall abdominal pain/discomfort and symptoms will improve, fecal Immunoglobulin A levels will change, pro-inflammatory cytokine levels will decrease and the production of regulatory cytokines as Interleukin 10 will improve following consumption of Lactobacillus casei DG (Enterolactis plus®).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, 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
- •Age > 18 years and ≤ 65 years.
- •A positive diagnosis of Irritable Bowel Syndrome regardless of bowel habit (both males and females), according to Rome III criteria.
- •Negative outcome of barium enema or left colonoscopy within the previous two years.
- •Negative relevant additional screening or consultation whenever appropriate.
- •Ability of conforming to the study protocol.
排除标准
- •Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant on the basis of predefined values.
- •Ascertained intestinal organic diseases, including ascertained celiac disease or inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticular disease, infectious colitis, ischemic colitis, microscopic colitis).
- •Previous major abdominal surgeries.
- •Active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment are also acceptable).
- •Untreated food intolerance such as ascertained or suspected lactose intolerance, as defined by anamnestic evaluation or, if appropriate, lactose breath test.
- •Assumption of probiotics or topic and/or systemic antibiotic therapy during the last month.
- •Systematical/frequent assumption of contact laxatives.
- •Females of childbearing potential, in the absence of effective contraceptive methods.
- •Pregnant women.
- •Inability to conform with protocol.
- •Treatment with any investigational drug within the previous 30 days.
- •Recent history or suspicion of alcohol abuse or drug addiction.
- •Previous participation in this study.
结局指标
主要结局
Consumption of rescue medication
时间窗: 1 day
Secretory Immunoglobulin A and cytokines levels in fecal samples as measured by ELISA test.
时间窗: 4 weeks
Abdominal pain/discomfort as measured by 11-point Numerical Rating Scale
时间窗: 1 day
evaluation performed using a daily 11-point Numerical Rating Scale scale from "0" (none) to "10" (very severe) - (responders are defined as patients with ≥ 30% reduction in the weekly mean abdominal pain and/or discomfort score, versus mean value of run-in period, in at least 2 weeks out of the 4 weeks of the treatment period)
Overall satisfaction with treatment as measured by Visual Analogue Scale
时间窗: 4 weeks
Irritable Bowel Syndrome degree-of-relief as measured by 7-point balanced ordinal scale
时间窗: 1 week
evaluation performed using weekly 7-point balanced ordinal scale, where "1"="completely relieved", "4"="unchanged" and "7"="as bad as I can imagine" - (responders are defined as patients reporting "completely relieved"=score 1 or "considerably relieved"=score 2 in at least 2 weeks out of the 4 weeks of the treatment period)
Stool frequency and consistency as assessed by Bristol Scale
时间窗: 1 day
Microbiota of fecal sample as characterized by Ion Torrent Personal Genome Machine sequencing of 16S ribosomal RNA-based amplicons
时间窗: 4 weeks
Quality of life as measured by Short-Form 12 Items Health Survey
时间窗: 4 weeks
evaluation performed using the validated Short-Form 12 Items Health Survey (SF-12) on a scale of 0 to 100
Anxiety and Depression as assessed by Hospital Anxiety and Depression Scale (HADS)
时间窗: 4 weeks
evaluation performed using Hospital Anxiety and Depression Scale (HADS): seven items each for anxiety and depression, with a 4-point Likert scale (0-3) for each item providing a minimum score of 0 and a maximum score of 21 on each sub-scale
次要结局
未报告次要终点