Acute pouchitis
Conditions
Interventions
Faecal microbiota transfer (FMT), administered by rectal enema and nasojejunal tube infusion.
Sponsors
Amsterdam UMC, location AMC
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients in clinical and endoscopic remission at week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| The main secondary endpoints are antibiotic-free clinical and endoscopic remission at week 52, and changes in microbiota signature, functional profiling as well as metabolic output from baseline to week 8 and week 52. To study the speed of clinical remission induction of pouchitis after FMT. | — |
Contacts
Public ContactDjuna de Jong
Amsterdam UMC, location AMC
Outcome results
None listed