Does the Microbiome in IBD Change Alongside Special Treatment Scenarios?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Microbiome
研究概览
简要总结
The purpose of this cohort study is to map, during one year in an e-health setting, patients having Inflammatory Bowel Disease (IBD) with mild to moderate activity in relation to dysbiosis (gut bacteria) and inflammation burden measured by disease activity questionnaires (HBI and SCCAI) and Fecal Calprotectin (FC) on any smart phone. And Secondarily how dysbiosis defined by a dysbiosis index (DI) ranging from 1-5 is related to changes in disease activity and FC under different treatments scenarios. Is a certain DI or specific bacteria probes related to increase or reduced relapse rate. Moreover change in above mentioned parameters/indices will also be correlated to QoL and a fatigue score.
详细描述
Among 2.500 IBD patients the investigators will consecutively from the Gastroenterology out-patient clinic at North Zealand University Hospital recruit in total 120 in the study.
At the out-patient consultation IBD patients will be informed about the project and the IBD eHealth nurse ensures that no exclusion criteria met by the patient.
Inclusion criteria: IBD patients in remission, SCCAI ≤ 2 (Simple Clinical Colitis Activity Index )) or HBI < 5 (Harvey & Bradshaw Activity Index ) or in mild to moderate disease activity ( SCCAI 3-4, HBI < 16) IBD patients who can read, speak and understand Danish IBD patients that can take advantage of the Internet and wireless network 18years or older.
Exclusion criteria: IBD patients with severe disease activity HB > 16 SCCAI ≥ 5 ) IBD patients with social, medical or psychological issues of a more complex character IBD patients with particularly complex issues such as drug and alcohol problems, severe mental / psychiatric disorders and / or serious social impact. IBD patients who cannot attend due to language barrier or cognitive disorder and IBD patients less than 18 years old.
When the patient has agreed to participate in this cohort study, they will measure their fecal calprotectin (FC) on any smart phone, rate their Disease activity (SCCAI or HBI) and send in a fecal sample for dysbiosis analysis/microbiome analysis. The Patients will do this every 3 month or on demand in an ehealth setting (see elaboration below).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •IBD patients in remission, SCCAI ≤ 2 (Simple Clinical Colitis Activity Index )) or HBI < 5 (Harvey & Bradshaw Activity Index ) or in mild to moderate disease activity ( SCCAI 3-4, HBI < 16)
- •IBD patients who can read, speak and understand Danish
- •IBD patients that can take advantage of the Internet and wireless network 18 years or older
排除标准
- •IBD patients with severe disease activity ( HB > 16 SCCAI ≥ 5 )
- •IBD patients with social, medical or psychological issues of a more complex character
- •IBD patients with complex issues such as drug and alcohol problems, severe mental / psychiatric disorders and / or serious social impact.
- •IBD patients who cannot attend due to language barrier or cognitive disorder.
- •Age less than 18 years.
结局指标
主要结局
Microbiome
时间窗: one year
Platform signal based on PCR technique of variable regions of 16S rRNA of 54 bacterial probes identifying specific gut bacteria on genus and species level. These platform signals goes through an algorithm to generate a Dysbiosis index (DI) ranging from 1-5. GA Analysis has developed this algorithm.
次要结局
- Total inflammation burden (TIBS)(one year)