NL-OMON23583暂停不适用
Efficacy and Safety of Multiple Faecal Microbiota Transfers in Acute Pouchitis
Amsterdam UMC, location AMC0 个研究点目标入组 20 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 20
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
入选标准
- •1. Age =18 and <70.
- •2. Ability to give informed consent.
- •3. IPAA for ulcerative colitis completed at least 4 months prior to inclusion in this study.
- •4. Episode of acute pouchitis, defined as a mPDAI = 5, and endoscopic subscore of = 2.
- •5. History of at least one earlier episode of pouchitis, which necessitated antibiotic treatment.
- •6. Women in their reproductive age period are required to use reliable contraception during participation in this study.
排除标准
- •1. Pouchitis due to surgery-related conditions (i.e. abscess, fistula, sinus of the pouch), identified by endoscopic assessment of the pouch.
- •2. Crohn’s disease.
- •3. Patients with signs of severe systemic inflammation (at least two of the following symptoms: temperature > 38.5 °C, tachycardia > 100 bpm (after rehydration), systolic blood pressure < 100 mmHg).
- •4. Patients with severe pouchitis on endoscopy who require immediate intervention, based on the discretion of the endoscopist.
- •5. Mechanical complications of the pouch (e.g. pouch stricture or pouch fistula).
- •6. Diverting ileostomy.
- •7. Condition leading to profound immunosuppression;
- •a. For example: HIV, infectious diseases leading to immunosuppression, bone marrow malignancies,
- •b. Use of systemic chemotherapy,
- •c. Child-Pugh B/C liver cirrhosis.
- •8. Use of systemic antibiotic therapy in the preceding 4 weeks.
- •9. Use of probiotic treatment in the preceding 4 weeks.
- •10. Use of concurrent anti-inflammatory drugs, e.g. thiopurines, anti-TNF, Vedolizumab. Ustekinumab, JAK-inhibitors, cyclosporine, methotrexate, prednisolone or topical treat-ment in the preceding 2 months before inclusion.
- •11. Life expectancy < 12 months.
- •12. Difficulty with swallowing.
- •13. Positive stool cultures for common enteric pathogens (Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic E. coli).
- •14. Positive C. Difficile stool test
- •15. Positive dual faeces test for pathogenic parasites e.g. Dientamoeba histolytica, Giar-dia Lamblia, Dientamoeba fragilis, Blastocystis hominis only if microscopically many or very many blastocysts are seen.
- •16. Pregnancy or women who give breastfeeding.
- •17. Vasopressive medication, intensive care stay.
- •18. Signs of ileus, diminished passage.
- •19. Allergy to macrogol or substituents, e.g. peanuts, shellfish.
- •20. Subject who has any condition that in the opinion of the investigator, would compro-mise the safety of the subject or the quality of the data and is an unsuitable candidate for the study.
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