NL-OMON50429招募中2 期
Encapsulated Faecal Microbiota Transplantation to Preserve Residual Beta Cell Function in Patients with Recently-Diagnosed Type 1 Diabetes Mellitus - The ENCAPSULATE-DM1 study
niversitair Medisch Centrum0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •1. Male or female recently diagnosed (0.5-3.5 years) with type 1 diabetes
- •2. Age: 18-65 years
- •3. BMI: 18-30 kg/m2
- •4. Remaining (detectable) residual beta cell function: detectable urinary or
- •plasma C- peptide at inclusion of the study.
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •1. History or symptoms of other autoimmune disease (e.g. hypo- or
- •hyperthyroidism, rheumatoid arthritis).
- •2. (Expected) prolonged comprised immunity (e.g. due to recent cytotoxic
- •chemotherapy or human immunodeficiency virus (HIV) infection with a CD4 count <
- •3. History of a severe disease of the digestive tract, such as celiac disease,
- •chronic diarrhoea (>=3 stools/day for >4 weeks), chronic obstipation (<2
- •defecations/week for >3 months), Irritable Bowel Syndrome (IBS) (according to
- •Rome IV criteria) or Inflammatory Bowel Disease (IBD).
- •4. Use of antibiotics, antacid drugs or proton pump inhibitors in the past 3
- •months or during the study period.
- •5. Use of pro-/prebiotics in the past three months or during the study period.
- •6. Smoking or illicit drug use (e.g. MDMA/amphetamine/cocaine/heroin/GHB) in
- •the past three months or use during the study period.
- •7. Use of >21 units of alcohol per week on average in the past three months
- •8. Pregnancy or breast feeding
研究者
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