ISRCTN58082603进行中（未招募）未知
Faecal Microbiota Transplantation in Ulcerative Colitis: an Interventional randomised single blind phase II trial
Abertawe Bro Morgannwg University LHB (UK)0 个研究点目标入组 30 人开始时间: 2015年7月24日最近更新:
适应症
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
- 2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30341117
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Newly diagnosed histologically confirmed ulcerative colitis with inflammation limited to the rectum or rectosigmoid (within 40cm of anal verge as measured by flexible sigmoidoscope)
- •2. Age 18 years and above
- •3. Able to give full informed written consent
- •4. Willing to return for sequential FMT dosing and endoscopic assessment
- •5. Not in receipt of standard medical treatment for colitis such as steroids or 5-ASA ie treatment naive
排除标准
- •1. Patients without a definitive diagnosis of UC (for example diagnosis of Crohn’s disease or infectious colitis)
- •2. Have colitis extending beyond 40cm from the anal verge
- •3. Have severe acute colitis (defined as greater than 6 bloodstained stools per 24 hrs with one of the following: pulse rate >90/ temperature >37.8’C/ haemoglobin <105g/L / ESR>30)
- •5. Abdominal tenderness on examination
- •6. Already commenced standard medical therapy for UC
- •7. Contraindication to oral bowel preparation
- •8. Allergy to study antibiotics
- •9. Age less than 18
- •10. Patient is within a vunerable group
- •11. Are pregnant
- •12. Are immuno-suppressed e.g. transplant patient
- •13. Known communicable disease;,at least 2 weeks full recovery from infectious disease e.g. chickenpox
- •14. Systemic autoimmunity, or atopic diseases
- •15. Previous prosthetic implant (for example metallic heart valve, joint replacement, ventriculoperitoneal shunt, cardiac stent)
- •16. Chronic pain syndromes (for example: fibromyalgia, chronic fatigue)
- •17. Neurologic, neuro-developmental or neurodegenerative disorders
- •18. Depression (requiring therapy)
- •19. Obesity (BMI>35)
- •20. Malignancy
- •21. Use of antibiotics for any indication within the past 3 months
- •22. Foreign travel to areas of enteric disease prevalence within 3 months
- •23. High risk sexual behaviour (examples: sexual contact with anyone with HIV/HTLV/AIDS or hepatitis B/C carrier, men who have sex with men (MSM))
- •24. Known exposure to HIV or hepatitis B/C
- •25. Current/previous use of injected drugs or intranasal cocaine
- •26. Tattooing, piercing, cosmetic botulinum toxin (Botox) or permanent makeup within 120 days (in line with Welsh Blood Transfusion guidelines)
- •27. Recent transfusion, transplant or skin graft
- •28. Risk factors for variant Creutzfeldt-Jakob disease e.g. blood transfusion or transplant after 1st January 1980
研究者
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