ISRCTN30359027进行中（未招募）未知
Feasibility of faecal microbiota transplantation in the management of obesity and type 2 diabetes: a randomised feasibility study
Abertawe Bro Morgannwg University Health Board0 个研究点目标入组 30 人开始时间: 2018年11月15日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- 性别
- All
入选标准
- •1. Aged between 18-70
- •2. Ability to give informed consent
- •3. BMI > 30 but < 40
- •4. Confirmed T2DM (within 24 months)
- •5. Ability to undergo a full screening assessment
- •6. Willingness to receive FMT via the nasojejunal route
- •7. Negative pregnancy test (if applicable)
- •8. Women of childbearing potential agree to use highly effective contraception measures until trial ends
排除标准
- •1. Abdominal tenderness on examination
- •2. BMI < 30 > 40
- •3. No evidence of T2DM or diagnosis of T2DM > 24 months
- •4. No clinical diagnosis of T1DM
- •5. Contraindication to receiving oral bowel preparation
- •6. Allergy to antibiotics used by the study
- •7. Age < 18 > 70
- •8. Allergy to proton pump inhibitor
- •9. Patient classed from vulnerable group
- •10. Previous GI / bariatric surgery
- •11. Contraindication to naso-jejunal tube placement
- •12. Pregnant
- •13. Immuno-suppressed
- •14. Known communicable disease; at least two weeks post full recovery from infectious disease
- •15. Systemic autoimmunity or atopic disease
- •16. Previous prosthetic implant
- •17. Foreign travel to areas of enteric disease prevalence within three months
- •18. Malignancy
- •19. Mental health disorder (requiring therapy)
- •20. Chronic pain syndromes (e.g. fibromyalgia)
- •21. Recent transfusion, transplant or skin graft
- •22. Current/previous use of injected drugs or intranasal cocaine
- •23. High risk sexual behaviour (sexual contact with anyone with HIV / HTLV / AIDS or hepatitis B/C, men who have sex with men (MSM))
- •24. Known exposure to HIV/hepatitis B/C
- •25. Tattooing, piercing, cosmetic botulinum (Botox) or permanent makeup within 120 days
- •26. Risk factors for variant Creutzfeldt-Jakob disease e.g blood transfusion or transplant after 1st January 1980
- •27. Neurologic, neuro-developmental or neurodegenerative disorders
- •28. Use of antibiotics for any indication within the past three months
研究者
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