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临床试验/ISRCTN15475780
ISRCTN15475780进行中(未招募)未知

The effect of microbiome manipulation through diet and Fecal Microbial Transplant (FMT) in inducing and maintaining remission in patients with mild to moderate ulcerative colitis: open label randomized controlled trial

All India Institute of Medical Sciences0 个研究点目标入组 66 人开始时间: 2022年3月16日最近更新:
适应症

试验速览

阶段
未知
状态
进行中(未招募)
入组人数
66

研究概览

简要总结

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35973787/ (added 17/08/2022)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Age between 18 – 65 years
  • 2. Patients with mild to moderate ulcerative colitis as assessed by simple clinical colitis activity index (SCCAI, 3 – 9) of any disease extent along with active disease on endoscopy (ulcerative colitis index of severity, UCEIS >1)
  • 3. Patients on stable doses of 5-ASA (5-amino salicylic acid) for past 4 weeks
  • 4. Patients on stable doses of azathioprine/6-mercaptopurine for past 3 months
  • 5. Patients who received biologics 6 months ago
  • 6. Patients on stable doses of topical therapy for past 2 weeks
  • 7. Patients on oral steroids (equivalent dose of prednisolone <20 mg/day)
  • 8. Patients giving consent for FMT
  • 9. Patients who agree to adhere to the diet schedule

排除标准

  • 1. Patients with severe disease activity
  • 2. Patients who have received topical 5-ASA or topical steroids in the past 2 weeks
  • 3. Patients with H/O of antibiotic or probiotic exposure in the past 4 weeks
  • 4. Patients requiring hospitalization
  • 5. Patients with H/O bowel surgery
  • 6. Patients with concomitant GI infection
  • 7. Pregnancy
  • 8. Patients with other comorbid illnesses

研究者

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