NCT05213910已完成不适用
Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PiLeJe
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Evolution of the severity of functional bowel disorders
研究概览
简要总结
The aim of this study is to determine the impact of a 10-day treatment with Lactichoc® on irritable bowel syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having IBS symptomatology meeting the Rome IV criteria;
- •Having a IBS-SSS score ≥150 ;
- •In a state of general and mental health compatible with participation in the study ;
- •Agreeing to maintain their lifestyle during the study (same dietary and physical activity habits) ;
- •Willing to take stool samples;
- •Able and willing to participate in the research by complying with the protocol procedures, especially regarding the consumption of the study product;
- •Having electronic tools (computer, tablet...) and an internet connection, allowing him/her to fill out the self-questionnaires of the study online;
- •Affiliated to a social security system.
排除标准
- •Have a history of hypersensitivity to any of the ingredients of the study product;
- •Under antibiotic treatment, or having stopped it for less than 14 days;
- •Under dietary supplementation (prebiotics or probiotics) or having stopped it for less than one month;
- •Having initiated or modified a background treatment for a comorbidity for less than one month, or planning to initiate it during the study, or planning to interrupt it during the study;
- •Having a lifestyle incompatible with the study as determined by the investigator;
- •Women who are pregnant or breastfeeding or who intend to become pregnant within the next 2 months;
- •Planning to travel extensively during the study period or unable to be contacted in case of emergency;
- •Psychologically or linguistically unable to understand and sign the informed consent;
- •Participating in another clinical trial or on an exclusion period from a previous clinical trial;
- •Under legal protection (guardianship, curatorship) or deprived of their rights following an administrative or judicial decision.
结局指标
主要结局
Evolution of the severity of functional bowel disorders
时间窗: 10 days
The severity of functional bowel syndrome is evaluated by Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
次要结局
- Global clinical evaluation(V2 (Day10) and Day30)
- Evolution of the severity of functional bowel disorders(Between V2 (Day10) and Day30 (20 days))
- Safety (tolerance to treatment)(V2 (Day10))
- Description of the anxiety-depressive disorders(V2 (Day10))
- Evaluation of the satisfaction concerning the product by a questionnaire(Day30)
- Description of quality of life(V1(Day0), V2 (Day10) and Day30)
- Treatment compliance(V2 (Day10))
- Description of the symptomatology(V1(Day0), V2 (Day10) and Day30)
研究者
研究点 (1)
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