Autologous Fecal Microbiota Transplantation for Diversion Colitis

NCT07674186 | Completed

• 1 other identifier: 2022-YJ-020
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Diversion Colitis

Keywords

Autologous Fecal Microbiota Transplantation; Diversion Colitis

Outcome Measures

Primary Outcomes (2)

• Change in Endoscopic Score

  Change from baseline to week 4 in modified Harig score (0-12), evaluating edema/erythema, loss of vascular pattern, friability/contact bleeding, and erosions/ulcerations (each 0-3). Higher scores indicate more severe inflammation. A blinded colorectal endoscopist performed colonoscopy through the stoma at week 0 and week 4.

  Baseline and Week 4

• Change in Histopathological Score

  Change from baseline to week 4 in composite histopathological score (0-9), assessing mucosal atrophy, crypt distortion, and inflammatory infiltrate (each 0-3). The average score of two blinded gastrointestinal pathologists was used; disagreements (\>2 points) were resolved by joint review.

  Baseline and Week 4

Secondary Outcomes (7)

• Wexner Incontinence Score

  Month 1, Month 3, Month 6 post-reversal

• Quality of Life - EORTC QLQ-C30 Global Health Status

  Baseline, Week 4, and Month 6 post-reversal

• Quality of Life - EORTC QLQ-CR29

  Baseline, Week 4, and Month 6 post-reversal

• Serum hs-CRP Level

  Baseline and Week 4

• Serum Albumin Level

  Baseline and Week 4

Study Arms (2)

Autologous Fecal Microbiota Transplantation (auto-FMT)

EXPERIMENTAL

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.

Other: Autologous Fecal Microbiota Transplantation (auto-FMT)

Saline Irrigation

OTHER

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.

Other: saline irrigation

Interventions

saline irrigation OTHER

Daily irrigation of 500 mL sterile normal saline (0.9%) at 37°C via the diverting stoma, using the same catheter and technique as the auto-FMT group.

Saline Irrigation

Autologous Fecal Microbiota Transplantation (auto-FMT) OTHER

Daily irrigation of autologous fecal microbiota suspension via the diverting stoma for 4 weeks.

Autologous Fecal Microbiota Transplantation (auto-FMT)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yongjian Liao: lead

Study Sites (1)

Department of Colorectal Surgery, The First People's Hospital of Lin'an District, Hangzhou

Hangzhou, Zhejiang, 311300, China

Location

Related Publications (4)

• Wang 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 RESULT

• Sam 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 RESULT

• Sohara 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 RESULT

• Vajn 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 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome Assessor and Statistician were blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: First People's Hospital Of Lin'an District, Hangzhou

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 29, 2026
• Study Start: June 1, 2022
• Primary Completion: March 31, 2025
• Study Completion: September 30, 2025
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE

Locations

CN (1)