Diversion ColitisNCT07674186
Autologous Fecal Microbiota Transplantation for Diversion Colitis
A study testing Autologous Fecal Microbiota Transplantation (auto-FMT) and saline irrigation in people with Diversion Colitis, run by Yongjian Liao at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diversion Colitis
- What is being tested?
- Autologous Fecal Microbiota Transplantation (auto-FMT) and saline irrigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Colorectal Surgery, The First People's Hospital of Lin'an District, Hangzhou
Hangzhou, Zhejiang, 311300
About this study
Official title: 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
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.
Read the detailed description
Background and Rationale
Diversion colitis frequently develops after fecal stream diversion, affecting most patients whose intestinal continuity remains interrupted for more than three to six months. While stoma reversal is definitive, many patients require prolonged diversion due to adjuvant chemotherapy, poor general condition, or anastomotic healing concerns. Existing medical therapies-including short-chain fatty acid enemas, 5-aminosalicylates, corticosteroids, and probiotics-lack consistent efficacy in randomized trials. Gut microbiota dysbiosis is a central driver of DC; restoring a diverse microbial community via fecal microbiota transplantation represents a rational approach. Autologous FMT using the patient's own stoma effluent avoids pathogen transmission, donor screening, and ethical concerns. However, no prospective RCT has systematically evaluated auto-FMT for DC using endoscopic and histopathological endpoints.
Study Design
Single-center, prospective, assessor-blinded, parallel-group, superiority randomized controlled trial with a 1:1 allocation ratio.
Participants
Adults aged 18-75 years with histopathologically confirmed rectal adenocarcinoma who underwent low anterior resection with temporary loop ileostomy, scheduled for reversal at 3-6 months after primary surgery, and with endoscopic DC (modified Harig score ≥4 at week 4 post-ileostomy). Key exclusion criteria: neoadjuvant chemoradiotherapy, pre-existing inflammatory bowel disease, recent antibiotic or probiotic use, severe organ dysfunction, pregnancy, or lactation.
Interventions
Auto-FMT group: Daily irrigations of autologous fecal microbiota suspension 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 sterile normal saline (0.9% NaCl) pre-warmed to 37°C, stirred, and filtered through two layers of sterile gauze. The filtrate was used within 30 minutes. Irrigation: a 14-16 French Foley catheter inserted 10-15 cm into the efferent limb of the loop ileostomy; suspension infused by gravity drip over 5-10 minutes; patients retained the suspension for at least 30 minutes before evacuation.
Control group: Daily irrigations of 500 mL sterile normal saline (37°C) using the same catheter and technique, with the same retention time.
Outcome Measures
Primary outcomes: Change from baseline to week 4 in endoscopic score (modified Harig score, 0-12) and histopathological score (composite of mucosal atrophy, crypt distortion, and inflammatory infiltrate, 0-9), assessed by blinded reviewers.
Secondary outcomes: Wexner incontinence score at 1, 3, and 6 months after stoma reversal; quality of life (EORTC QLQ-C30 and QLQ-CR29) at baseline, week 4, and 6 months post-reversal; serum hs-CRP, albumin, and fecal calprotectin at baseline and week 4; adverse events (CTCAE v5.0); treatment adherence (≥80% of 28 sessions).
Sample Size
33 patients per group (total 66) to detect a mean endoscopic score reduction difference of 1.5 points (assuming SD 2.0 in auto-FMT group and SD 1.8 in control group), 80% power, two-sided α = 0.05, accounting for a 20% dropout rate.
Statistical Analysis
Primary analysis was intention-to-treat. Change scores were analyzed using ANCOVA with baseline score as covariate. Secondary outcomes: Wexner scores with generalized estimating equations; quality of life with ANCOVA; biomarkers with Mann-Whitney U tests. Missing data were handled with multiple imputation. Two-tailed p < 0.05 was considered significant.
Ethical Approval
The protocol was approved by the Ethics Committee of Lin'an First People's Hospital, Hangzhou (Approval No.: Lin'an First People's Hospital Lun Yan Shen 2022 No.20, dated April 29, 2022). Written informed consent was obtained from all participants. The study followed the Declaration of Helsinki.
- Conditions
- Diversion Colitis
- Being tested
- Autologous Fecal Microbiota Transplantation (auto-FMT), saline irrigation
- Keywords
- Autologous Fecal Microbiota Transplantation, Diversion Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Fecal Microbiota Transplantation (auto-FMT)Other
Daily irrigation of autologous fecal microbiota suspension via the diverting stoma for 4 weeks.
saline irrigationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: saline irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and Week 4
Secondary outcomes (7)
Wexner Incontinence Score
Wexner incontinence score (0-20, where 0 = perfect continence, 20 = complete incontinence) assessed at 1, 3, and 6 months after stoma reversal.
Measured: Month 1, Month 3, Month 6 post-reversal
Quality of Life - EORTC QLQ-C30 Global Health Status
Global health status / quality of life score from the EORTC QLQ-C30 questionnaire. Higher scores indicate better quality of life.
Measured: Baseline, Week 4, and Month 6 post-reversal
Quality of Life - EORTC QLQ-CR29
Disease-specific quality of life assessed by the EORTC QLQ-CR29 module, covering symptoms and functioning domains relevant to colorectal cancer patients.
Measured: Baseline, Week 4, and Month 6 post-reversal
Serum hs-CRP Level
High-sensitivity C-reactive protein (hs-CRP) measured in mg/L from serum samples.
Measured: Baseline and Week 4
Serum Albumin Level
Albumin concentration measured in g/L from serum samples.
Measured: Baseline and Week 4
Fecal Calprotectin Level
Fecal calprotectin concentration measured by ELISA (μg/g), as a biomarker of intestinal inflammation.
Measured: Baseline and Week 4
Adverse Events and Treatment Adherence
Adverse events graded according to CTCAE v5.0 (incidence, severity, and causality). Treatment adherence defined as completion of ≥80% of 28 scheduled irrigation sessions.
Measured: Throughout the 4-week intervention period for adverse events; at end of intervention for adherence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start1 Jun 2022
- Primary completion31 Mar 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diversion ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yongjian Liao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongjian Liao, First People's Hospital Of Lin'an District, Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674186
- Sponsor's protocol ID
- 2022-YJ-020
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in this manuscript will be made available to researchers who provide a methodologically sound proposal, for the purpose of individual participant data meta-analysis or other approved research. The study protocol, statistical analysis plan, and informed consent form will also be available. Data will be accessible immediately after publication, upon reasonable request to the corresponding author.
Publications
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.
PubMed 30181015Sam 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.
PubMed 39290660Sohara 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.
PubMed 23382632Vajn 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.
PubMed 25157957
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07674186
- Acronym / sponsor ID
- 2022-YJ-020
- Conditions
- Diversion Colitis
- Keywords
- Autologous Fecal Microbiota Transplantation, Diversion Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Yongjian LiaoUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Rationale
Diversion colitis frequently develops after fecal stream diversion, affecting most patients whose intestinal continuity remains interrupted for more than three to six months. While stoma reversal is definitive, many patients require prolonged diversion due to adjuvant chemotherapy, poor general condition, or anastomotic healing concerns. Existing medical therapies-including short-chain fatty acid enemas, 5-aminosalicylates, corticosteroids, and probiotics-lack consistent efficacy in randomized trials. Gut microbiota dysbiosis is a central driver of DC; restoring a diverse microbial community via fecal microbiota transplantation represents a rational approach. Autologous FMT using the patient's own stoma effluent avoids pathogen transmission, donor screening, and ethical concerns. However, no prospective RCT has systematically evaluated auto-FMT for DC using endoscopic and histopathological endpoints.
Study Design
Single-center, prospective, assessor-blinded, parallel-group, superiority randomized controlled trial with a 1:1 allocation ratio.
Participants
Adults aged 18-75 years with histopathologically confirmed rectal adenocarcinoma who underwent low anterior resection with temporary loop ileostomy, scheduled for reversal at 3-6 months after primary surgery, and with endoscopic DC (modified Harig score ≥4 at week 4 post-ileostomy). Key exclusion criteria: neoadjuvant chemoradiotherapy, pre-existing inflammatory bowel disease, recent antibiotic or probiotic use, severe organ dysfunction, pregnancy, or lactation.
Interventions
Auto-FMT group: Daily irrigations of autologous fecal microbiota suspension 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 sterile normal saline (0.9% NaCl) pre-warmed to 37°C, stirred, and filtered through two layers of sterile gauze. The filtrate was used within 30 minutes. Irrigation: a 14-16 French Foley catheter inserted 10-15 cm into the efferent limb of the loop ileostomy; suspension infused by gravity drip over 5-10 minutes; patients retained the suspension for at least 30 minutes before evacuation.
Control group: Daily irrigations of 500 mL sterile normal saline (37°C) using the same catheter and technique, with the same retention time.
Outcome Measures
Primary outcomes: Change from baseline to week 4 in endoscopic score (modified Harig score, 0-12) and histopathological score (composite of mucosal atrophy, crypt distortion, and inflammatory infiltrate, 0-9), assessed by blinded reviewers.
Secondary outcomes: Wexner incontinence score at 1, 3, and 6 months after stoma reversal; quality of life (EORTC QLQ-C30 and QLQ-CR29) at baseline, week 4, and 6 months post-reversal; serum hs-CRP, albumin, and fecal calprotectin at baseline and week 4; adverse events (CTCAE v5.0); treatment adherence (≥80% of 28 sessions).
Sample Size
33 patients per group (total 66) to detect a mean endoscopic score reduction difference of 1.5 points (assuming SD 2.0 in auto-FMT group and SD 1.8 in control group), 80% power, two-sided α = 0.05, accounting for a 20% dropout rate.
Statistical Analysis
Primary analysis was intention-to-treat. Change scores were analyzed using ANCOVA with baseline score as covariate. Secondary outcomes: Wexner scores with generalized estimating equations; quality of life with ANCOVA; biomarkers with Mann-Whitney U tests. Missing data were handled with multiple imputation. Two-tailed p < 0.05 was considered significant.
Ethical Approval
The protocol was approved by the Ethics Committee of Lin'an First People's Hospital, Hangzhou (Approval No.: Lin'an First People's Hospital Lun Yan Shen 2022 No.20, dated April 29, 2022). Written informed consent was obtained from all participants. The study followed the Declaration of Helsinki.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous Fecal Microbiota Transplantation (auto-FMT) | Experimental | Other: Autologous Fecal Microbiota Transplantation (auto-FMT)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. |
| Saline Irrigation | Other | Other: saline irrigationDaily 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Fecal Microbiota Transplantation (auto-FMT)Daily irrigation of autologous fecal microbiota suspension via the diverting stoma for 4 weeks. | Other | Autologous Fecal Microbiota Transplantation (auto-FMT) |
| saline irrigationDaily 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. | Other | Saline Irrigation |
Primary outcome
Change in Endoscopic Score
Time frame: Baseline and Week 4
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.
Change in Histopathological Score
Time frame: Baseline and Week 4
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.
7 secondary outcomes
Wexner Incontinence Score
Time frame: Month 1, Month 3, Month 6 post-reversal
Quality of Life - EORTC QLQ-C30 Global Health Status
Time frame: Baseline, Week 4, and Month 6 post-reversal
Quality of Life - EORTC QLQ-CR29
Time frame: Baseline, Week 4, and Month 6 post-reversal
Serum hs-CRP Level
Time frame: Baseline and Week 4
Serum Albumin Level
Time frame: Baseline and Week 4
Fecal Calprotectin Level
Time frame: Baseline and Week 4
Adverse Events and Treatment Adherence
Time frame: Throughout the 4-week intervention period for adverse events; at end of intervention for adherence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Results publication: PubMed 30181015Wang 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.
- Results publication: PubMed 39290660Sam 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.
- Results publication: PubMed 23382632Sohara 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.
- Results publication: PubMed 25157957Vajn 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in this manuscript will be made available to researchers who provide a methodologically sound proposal, for the purpose of individual participant data meta-analysis or other approved research. The study protocol, statistical analysis plan, and informed consent form will also be available. Data will be accessible immediately after publication, upon reasonable request to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Fecal Microbiota Transplantation (auto-FMT) and saline irrigation in people with Diversion Colitis, run by Yongjian Liao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Endoscopic Score (time frame: Baseline and Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07674186, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.