Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis - a Randomized, Double-blinded, Safety and Pilot-efficacy Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of adverse events (AE) severity grade 2 or more assessed by CTCAE v5.0. during the first week after intervention (FMT or placebo).
研究概览
简要总结
This clinical trial aims to assess the safety and effectiveness of faecal Microbiota Transplantation (FMT) in improving chronic diarrhea symptoms among patients with systemic sclerosis.
详细描述
The present study aims to assess the feasibility, pilot efficacy, and safety of FMT for patients with Systemic Sclerosis.
Participants will undergo two interventions in this present study.
In the first intervention, participants are randomized 1:1 for either active FMT or Placebo. This first intervention consists of two doses of FMT with a 3-7 day gap.
In the second intervention, all participants receive 1 dose of active FMT treatment.
This study design allows researchers to evaluate the safety of FMT in this patient group, and compare the effects of FMT in the FMT-treated group vs the placebo group, to see if FMT promotes remission of Chronic diarrhea. Furthermore, researchers will be able to gain insights into whether 2 initial doses are superior to one.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study is blinded throughout the active study period, both the patient and investigator are blinded.
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
- •Participants > 18 years
- •Fulfilling and previously diagnosed with SSc according to the 2013 American College of Rheumatology/European League against rheumatisms SSs classification criteria[23] by rheumatologist or dermatologist.
- •Chronic diarrea is defined as loose or watery stools, three or more times a day, a minimum of 50% of the days within the last four weeks.
排除标准
- •Inability to understand Danish spoken or written and/or Trial procedures.
- •Known or anticipated pregnancy (excluded by male sex, postmenopausal women, or otherwise negative U-HCG)
- •Previous treatment with FMT
- •Treatment with antibiotics within the past 6 weeks
- •Changes in morphine treatment within the past 4 weeks
- •Ongoing infection with Clostridioides difficile (negative PCR test)
- •Known serious gastrointestinal disease or GI infection (diagnosed with e.g. inflammatory bowel disease and/or gastrointestinal cancer)
- •Dysregulated thyroid disease (TSH) blood sample from previous consultations maximum 6 months old from
- •Known intestinal stricture
- •Planned MR scan within the study period
- •Pacemaker/ICD
- •Previous abdominal surgery (minor surgical procedures ex. appendectomy is allowed)
- •Changes in medicine that affect the GI tract within the past four weeks.
- •Known Severe end-organ disease
- •Lung disease with forced vital capacity(FVC)<50% and/or diffusing lung capacity for carbon monoxide (DLCO) <40%
- •Severe heart failure with ejection fraction <30%
- •End-stage kidney disease with glomeration rate<30ml/min
研究组 & 干预措施
Active treatment
Active capsule FMT-treatment
干预措施: Faecal Microbiota Transplantation (FMT) (Procedure)
Placebo
Placebo capsules are given.
干预措施: Placebo (Procedure)
结局指标
主要结局
Number of adverse events (AE) severity grade 2 or more assessed by CTCAE v5.0. during the first week after intervention (FMT or placebo).
时间窗: The first week after treatment.
Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention.
次要结局
- Blood plasma Fibrosis markers(At baseline and between each treatment, up to four weeks after last intervention.)
- Blood parameters(At baseline and between each treatment, up to four weeks after last intervention.)
- Patient-reported treatment outcome on symptoms(The first week after treatment.)
- Faecal microbiota composition(At baseline and between each treatment, up to 4 weeks after last intervention)
- Blood plasma proteomics(At baseline and between each treatment, up to four weeks after last intervention.)
- Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention.(One week after each treatment)
- Patient-reported overall symptom burden(Each week for a total of 26 weeks.)
- Objective measures from the low-dose CT scan.(At baseline and 4 weeks after first intervention)
- Breath Test(At baseline and 4 weeks after first intervention)
- Faecal-calprotectin(At Baseline and 4 weeks after Intervention 1 & 2)
- Health-related Quality of life(At baseline and 4 weeks after Intervention 1 & 2)
- Patient perception of FMT treatment satisfaction(At 4 weeks after interventions 1 & 2)
- Patient-reported outcomes from questionnaires.(At Baseline and 4 weeks after Intervention 1 & 2)
- Objective measures from the wireless motility capsule.(At baseline)
研究者
Klaus Krogh
MD, DMSc, PhD, Professor
University of Aarhus