Modified Bacteria for Mn-based antioxIdants Production and Delivery for Gut Inflammation Control
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Treatments acceptability
研究概览
简要总结
Patients with IBD experience complex therapeutic pathways. The development of new treatments, more effective and free of side effects, is a therapeutic need. However, such therapeutic innovations can only be effective if they are accepted by the target populations.
The objective of this study is to analyze, in patients with chronic inflammatory bowel diseases, the acceptability of 4 different treatments: chemically modified bacteria treatment, genetically modified bacteria treatment, probiotics, and fecal microbiota transplantation.
The acceptability of the treatments, i.e. the patients' responses and their rationalizations, will constitute the evaluation criterion and the result of the research.
This study will also allow us to evaluate the impact of IBD on quality of life and well-being. Research factors associated with quality of life and well-being, based on dedicated questions (scales validated and included in the questionnaire), evaluate the differential acceptability of the 4 treatments studied. Finally, cross-analyses between health, socio-demographic factors, quality of life and well-being will be performed.
详细描述
Patients with IBD experience complex treatment pathways. Therapeutic innovations are necessary but can only be effective if they are accepted by the target populations.
It is therefore a question of understanding and measuring the acceptability of innovative treatments for IBD. Through an analysis carried out by the patients regularly followed for a IBD in day hospital will answer questionnaires, to allow us to:
- understand the representations of competing therapies for this type of pathologies, i.e. conventional drug treatments, probiotics, TMF and CMB and GMB;
- measure the acceptability of CMB and GMB by the patients themselves;
- understand the links between the acceptability of treatments and the health status / socio-economic characteristics of patients.
The main criterion for the acceptability of treatments involving bacteria will be the answers to questions relating to this question.
It will be a question of determining which treatment(s) is, or are, the most easily accepted by patients with IBD, understood as a population, understanding why patients prefer this or that treatment, but also "how many" of them say they are ready to use them. In other words, the measures will be based on declarative quantitative questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic inflammatory bowel diseases.
- •Patients over 18 years old.
- •Not opposed to participating in the study. - Patients whose diagnosis of IBD was made more than 6 months ago
排除标准
- •patients with cognitive disorders,
- •patients who cannot read and understand French
结局指标
主要结局
Treatments acceptability
时间窗: 6 months
It will be a question of determining which treatment(s) is, or are, the most easily accepted by patients with IBD, understanding why patients prefer this or that treatment, but also "how many" of them say they are ready to use them. In other words, the measures will be based on quantitative declarative questionnaires
次要结局
- Quality of life(9 months)
- Factors associated with quality of life and well-being, based on the questionnaire(12 months)
- Differential acceptability of the 4 treatments studied(12 months)