Evaluation of the Effects of Colipral® (E.Coli 5C LMG S-33222) on Microbiota Gut Composition in Patients Presenting With Ulcerative Colitis During Remission Phase and Functional Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Microbiota gut composition
研究概览
简要总结
The study is a double-blind, placebo-controlled, crossover, randomised trial, in which enrolled subjects will be included for 18 months. This study aims to evaluate the effect of the Colipral as a Food Supplement prescribed according to the standard of care of patients suffering UC during remission phase and DGBI.
The primary objective of the study is to evaluate the variation in gut microbiota, specifically focusing on bacterial diversity and abundance, in patients with UC during the remission phase and DGBI.
The secondary objective of the study is to evaluate the clinical parameters variations (based on fecal calprotectin and IBDQ's score before and after the treatment), the severity of gastrointestinal symptoms, the quality of life, and the maintenance of the remission phase in patients with UC in remission and DGBI.
详细描述
The primary endpoint will be the variation in gut microbiota analyzed through 16S rRNA gene sequencing from a fecal sample of patients presenting UC during remission phase and DGBI at three time points: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).
The secondary endpoint will be the assessment of the clinical parameters variation based on fecal calprotectin in patients presenting UC during remission phase and DGBI at three time points: T=0 (baseline, before treatment), T=1 (after an additional 60 days of treatment A or B), and T=3 (after 60 days of treatment A or B).
The severity of gastrointestinal symptoms and quality of life will be assessed using the IBDQ, IBS SSS, VAS, and Bristol Stool Scale questionnaires at three time points: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B). Patients' dietary habits will be analysed using the WCRF questionnaire at the first and final visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
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
- 否
入选标准
- •Diagnosis of UC confirmed by clinical, endoscopic and histopathological evidence.
- •Disease in remission phase confirmed by clinical, endoscopic and histopathological evidence for at least 6 months
- •Diagnosis of disorders of gut-brain interaction (DGBI): IBS-D, IBS-M, bloating, and abdominal pain
- •Male/female
- •Age in the range 18-70 years
- •Subjects capable of conforming to the study protocol
- •Subjects who have given their free and informed consent
排除标准
- •History of gastrointestinal disorders or gastrointestinal surgery interfering with gastrointestinal function
- •Subjects with untreated food intolerance, i.e. remaining symptomatic despite the withdrawal of the suspected food
- •Currently following a restrictive diet (for example low FODMAPs diet or vegan diet)
- •Females of childbearing potential, in the absence of effective contraceptive methods
- •Subjects who become unable to conform to protocol
- •Recent history or suspicion of alcohol abuse or drug addiction
- •Indication for the initiation of a new drug therapy during the study
- •History of current or recent antibiotic or probiotics use within the last 30 days
- •Subjects who are treated with antibiotics
研究组 & 干预措施
Dietary Supplement Group (Treatment A)
In this arm patients receive 2 tablets/day of Colipral (1/breakfast, and 1/dinner, before the meal) for 60 days
干预措施: Food Supplement Colipral in film-coated tablets containing Escherichia coli 5C LMG S-33222 (Dietary Supplement)
Placebo Group (Treatment B)
In this arm patients receive 2 tablets/day of placebo (1/breakfast, and 1/dinner, before the meal) for 60 days
干预措施: Placebo (Other)
结局指标
主要结局
Microbiota gut composition
时间窗: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).
The primary endpoint will be the variation in gut microbiota analyzed through 16S rRNA gene sequencing from a fecal sample of patients presenting UC during remission phase and DGBI.
次要结局
- Fecal calprotectin levels(T=0 (baseline, before treatment), T=1 (after an additional 60 days of treatment A or B), and T=3 (after 60 days of treatment A or B))
- Quality of life in patiets with inflammatory bowel disease(T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).)
- Dietary habits(T=0 (baseline, before treatment) and T=3 (after taking both treatment A and treatment B))
- Gastrointestinal symptom severity in patients with Irritable Bowel Syndrome(T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).)
- Severity of gastrointestinal symptoms(T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).)
研究者
ZINGONE FABIANA
Professor
University of Padova