Faecal Microbiota Transplantation for Patients With Diabetes Mellitus Type 1 and Severe Gastrointestinal Neuropathy: a Randomised, Double-blinded Safety and Pilot-efficacy Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of adverse events of severity grade 2 or more assessed by CTCAE v5.0 during the first week after first intervention (FMT or placebo).
研究概览
简要总结
A randomised, double-blinded and placebo-controlled intervention study. The study aim to evaluate the feasibility, safety and pilot-efficacy of faecal microbiota transplantation as a treatment of severe gastrointestinal neuropathy in patients with diabetes mellitus type 1.
详细描述
Diabetes type 1 may cause damage to nerve cells in the gut causing neuropathy that leads to changes in gastric and intestinal motility. This change predisposes to an abnormal amounts and composition of bacteria in the gut, probably leading to uncontrollable diarrhea and severely impaired quality of life. Transferal of intestinal microbiota from a healthy donor to a patient is called faecal microbiota transplantation (FMT). FMT may potentially change the bacteria in the gut and reduce gastrointestinal symptoms. However, FMT may also have potential side effects, especially in persons with autonomic neuropathy and delayed transit through the gut.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥ 18 years old), male or female patients with DM1 for at least 5 years and average of or above 40 points in the questionnaire: Gastrointestinal syndrome rating scale - irritable bowel syndrome version (GSRS-IBS).
排除标准
- •Inability to understand Danish or the trial procedures
- •Known or anticipated pregnancy
- •Known severe renal insufficiency
- •Antibiotic use in the prior 4 weeks
- •Treatment with morphine
- •Ongoing infection with Clostridioides difficile or pathogenic intestinal bacteria or parasites
- •Known gastrointestinal disease or GI infection
- •Patients diagnosed with intestinal stricture
- •Patients with other known disorder that can cause gastroparesis
- •Patients with planned MR scan within 4 weeks
- •Patients with pacemaker/ICD
- •Previous abdominal surgery
- •Changes in medicine that affects the GI tract in the prior 4 weeks
结局指标
主要结局
Number of adverse events of severity grade 2 or more assessed by CTCAE v5.0 during the first week after first intervention (FMT or placebo).
时间窗: One week after the first intervention
Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention.
次要结局
- Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention.(One week after each intervention)
- Objective measures from the breath test.(at baseline and 4 weeks after the first intervention)
- Blood samples.(at baseline and 4 weeks after each intervention period)
- Objective measures from the low-dose CT scan.(at baseline and 4 weeks after the first intervention)
- Patient-reported outcomes obtained from the bowel habit diary.(Each patient fills out the diary every day for one week at baseline, for one week starting at each day of the two interventions and for one week at the long term follow-up at week 26)
- Patient-reported outcomes from questionnaires.(at baseline and 4 weeks after each intervention period and at long term follow-up at week 26)
- Objective measures from the wireless motility capsule.(at baseline and 4 weeks after each intervention period)
- Microbiota analysis on faecal samples.(at baseline and 4 weeks after each intervention period)