Clinical trial · Interventional
Autologous Fecal Microbiota Transplantation for Anal Function Recovery After Ileostomy Reversal in Rectal Cancer
Autologous Fecal Microbiota Transplantation for Anal Function Recovery After Ileostomy Reversal in Patients With Rectal Cancer: A Prospective, Single-center, Single-arm, Open-label Clinical Study
- 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)
This prospective, single-center, single-arm, open-label clinical study aims to evaluate whether autologous fecal microbiota transplantation can improve bowel and anal function after ileostomy reversal in patients with rectal cancer who underwent radical rectal cancer surgery with protective loop ileostomy. Eligible patients will receive autologous fecal microbiota transplantation before ileostomy reversal. The primary outcome is the Low Anterior Resection Syndrome score at 3 months after ileostomy reversal. Secondary outcomes include fecal incontinence score, colonoscopic findings before ileostomy reversal, gut microbiota profiles, inflammatory markers, anorectal manometry, pelvic floor electromyography, and safety outcomes.
Conditions
Conditions (6)
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 | — |
| Fecal Incontinence | — | UNRESOLVED | — |
| Gut Microbiota Dysbiosis | — | UNRESOLVED | — |
| Ileostomy | — | UNRESOLVED | — |
| Low Anterior Resection Syndrome | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Fecal Microbiota Transplantation | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Autologous Fecal Microbiota Transplantation Group
- description
- Participants with rectal cancer who underwent radical rectal cancer surgery with protective loop ileostomy will receive autologous fecal microbiota transplantation before ileostomy reversal.
- interventionNames
- Biological: Autologous Fecal Microbiota Transplantation
Primary outcomes (1)
- measure
- Low Anterior Resection Syndrome Score at 3 Months After Ileostomy Reversal
- timeFrame
- 3 months after ileostomy reversal
- description
- Low Anterior Resection Syndrome (LARS) score will be assessed using the LARS questionnaire at 3 months after ileostomy reversal. The total score ranges from 0 to 42 points, with higher scores indicating more severe bowel dysfunction. Scores of 0-20 indicate no LARS, 21-29 indicate minor LARS, and 30-42 indicate major LARS.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 to 75 years. 2. Histologically or clinically confirmed rectal cancer with the lower tumor margin less than 12 cm from the anal verge. 3. Undergoing radical rectal cancer surgery with protective loop ileostomy. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Able to understand the study procedures and willing to provide written informed consent. Exclusion Criteria: 1. History of inflammatory bowel disease, bacterial colitis, or other preoperative colonic inflammatory disease. 2. Requirement for emergency surgery due to intestinal obstruction, perforation, bleeding, or other emergency conditions. 3. Pregnant or lactating women. 4. Presence of clinically significant gut microbiota dysbiosis before enrollment, as judged by the investigator. 5. Planned postoperative radiotherapy, chemotherapy, or chemoradiotherapy. 6. Poor compliance, inability to tolerate the intervention, or judged by the investigator to be unsuitable for participation in this clinical study. 7. Severe postoperative complications such as anastomotic leakage.
References
Publications (0)
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