Clinical trial · Interventional
Autologous Fecal Microbiota Transplantation for Diversion Colitis
Autologous Fecal Microbiota Transplantation Via the Diverting Stoma Ameliorates Diversion Colitis in Patients With Temporary Ileostomy for Rectal Cancer: A Randomized Controlled Trial With Endoscopic and Histopathological Assessment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Diversion colitis (DC) is a common inflammatory complication in patients with temporary ileostomy after rectal cancer surgery, and no standardized medical treatment exists. This prospective, assessor-blinded, parallel-group, randomized controlled trial evaluated whether autologous fecal microbiota transplantation (auto-FMT) delivered through the diverting stoma ameliorates DC and improves post-reversal outcomes. Sixty-six patients with endoscopically confirmed DC were randomized 1:1 to receive daily auto-FMT (n=33) or saline irrigation (n=33) for four weeks. The primary endpoints are changes from baseline to week 4 in endoscopic (modified Harig score, 0-12) and histopathological (0-9) scores. Secondary endpoints include Wexner incontinence score, quality of life (EORTC QLQ-C30/CR29), inflammatory biomarkers, and safety. The study is designed to test whether auto-FMT produces superior improvements in endoscopic and histopathological severity compared with saline control, and leads to better functional outcomes after stoma reversal.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diversion Colitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Fecal Microbiota Transplantation (auto-FMT) | Other | — | UNRESOLVED |
| saline irrigation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Autologous Fecal Microbiota Transplantation (auto-FMT)
- description
- Daily irrigations of autologous fecal microbiota suspension via the diverting stoma for 4 weeks. Preparation: 50-80 g of fresh stool collected from the patient's stoma bag within 2 hours of passage, homogenized with 500 mL of sterile normal saline (0.9% NaCl) pre-warmed to 37 °C, stirred, and filtered through two layers of sterile gauze. The filtrate is used within 30 minutes. Irrigation: A 14-16 French Foley catheter inserted 10-15 cm into the efferent limb of the loop ileostomy, balloon inflated with 5-8 mL of air. The suspension is infused by gravity drip (bag 40-50 cm above stoma) over 5-10 minutes. Patients retain the suspension for at least 30 minutes before evacuation. Vital signs are monitored for the first 3 days.
- interventionNames
- Other: Autologous Fecal Microbiota Transplantation (auto-FMT)
- type
- OTHER
- label
- Saline Irrigation
- description
- Daily irrigations of 500 mL sterile normal saline (0.9% NaCl) pre-warmed to 37 °C via the diverting stoma for 4 weeks. A 14-16 French Foley catheter is inserted 10-15 cm into the efferent limb of the loop ileostomy, and the balloon is inflated with 5-8 mL of air. Saline is infused by gravity drip (bag 40-50 cm above stoma) over 5-10 minutes. Patients retain the saline for at least 30 minutes before evacuation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathologically confirmed rectal adenocarcinoma. * Low anterior resection with temporary loop ileostomy. * Age 18-75 years. * Scheduled for ileostomy reversal at 3-6 months after primary surgery. * Endoscopic confirmation of diversion colitis at week 4 post-ileostomy (modified Harig score ≥4, range 0-12). * Written informed consent. Exclusion Criteria: * Neoadjuvant chemoradiotherapy. * Pre-existing inflammatory bowel disease, irritable bowel syndrome, or chronic constipation. * Previous colorectal surgery (other than index surgery). * Active infection requiring systemic antibiotics within 4 weeks before enrollment. * Use of probiotics, prebiotics, or antibiotics within 4 weeks before enrollment. * Severe organ dysfunction (Child-Pugh B/C cirrhosis, end-stage renal disease). * Pregnancy or lactation. * Any condition precluding protocol compliance or outcome assessment.
References
Publications (4)
- RESULTWang JW, Kuo CH, Kuo FC, Wang YK, Hsu WH, Yu FJ, Hu HM, Hsu PI, Wang JY, Wu DC. Fecal microbiota transplantation: Review and update. J Formos Med Assoc. 2019 Mar;118 Suppl 1:S23-S31. doi: 10.1016/j.jfma.2018.08.011. Epub 2018 Sep 1. PMID 30181015
- RESULTSam SW, Hafeez B, Ong HI, Gill S, Smibert O, Lavelle A, Burgess A, Proud D, Mohan H. The impact of faecal diversion on the gut microbiome: a systematic review. Gut Microbiome (Camb). 2024 Feb 19;5:e4. doi: 10.1017/gmb.2024.1. eCollection 2024. PMID 39290660
- RESULTSohara N, Hagiwara S, Arai R, Iizuka H, Onozato Y, Kakizaki S. Can endoscopic submucosal dissection be safely performed in a smaller specialized clinic? World J Gastroenterol. 2013 Jan 28;19(4):528-35. doi: 10.3748/wjg.v19.i4.528. PMID 23382632
- RESULTVajn K, Suler D, Plunkett JA, Oudega M. Temporal profile of endogenous anatomical repair and functional recovery following spinal cord injury in adult zebrafish. PLoS One. 2014 Aug 26;9(8):e105857. doi: 10.1371/journal.pone.0105857. eCollection 2014. PMID 25157957