Diversion Colitis, Fecal Incontinence, Gut Microbiota Dysbiosis, Ileostomy, Low Anterior Resection Syndrome, Rectal Cancer
Conditions
Keywords
autologous fecal microbiota transplantation, rectal cancer, ileostomy reversal, low anterior resection syndrome, LARS score, diversion colitis, gut microbiota, 16S rRNA sequencing, anal function, bowel function
Brief summary
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.
Detailed description
Patients with rectal cancer who undergo radical resection with protective loop ileostomy may experience diversion-related changes in the distal bowel, gut microbiota dysbiosis, diversion colitis, and impaired bowel function after ileostomy reversal. Autologous fecal microbiota transplantation may help restore the intestinal microbial environment in the defunctioned bowel and improve postoperative bowel function. In this study, eligible patients will undergo standard radical rectal cancer surgery with protective loop ileostomy. At approximately 8 weeks after surgery, patients without severe postoperative complications such as anastomotic leakage will undergo anal swab sampling for 16S rRNA gene sequencing. Autologous fecal microbiota transplantation will be performed once weekly at postoperative weeks 8, 9, 10, and 11. At approximately 12 weeks after surgery, colonoscopy will be performed to evaluate the distal bowel mucosa, and intestinal secretion samples will be collected for 16S rRNA gene sequencing. Ileostomy reversal will then be performed according to routine clinical practice. Bowel function will be followed for 3 months after ileostomy reversal, with the primary endpoint being the LARS score at 3 months after reversal.
Interventions
Autologous fecal microbiota transplantation will be prepared from the participant's own fecal material collected from the ileostomy output. Approximately 50 g of fecal material will be mixed with 100 mL sterile normal saline, homogenized, filtered through sterile sieves, and administered slowly into the distal bowel via transanal catheter/enema. The procedure will be performed once weekly at postoperative weeks 8, 9, 10, and 11, for a total of four administrations. Participants will be observed after the procedure according to the study protocol.
Sponsors
Peking University People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Low Anterior Resection Syndrome Score at 3 Months After Ileostomy Reversal | 3 months after ileostomy reversal | 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
| Measure | Time frame | Description |
|---|---|---|
| Colonoscopic Mucosal Findings Before Ileostomy Reversal | Approximately 12 weeks after initial surgery and before ileostomy reversal | The distal bowel mucosa will be evaluated by colonoscopy before ileostomy reversal. Findings related to diversion colitis, including mucosal erythema, edema, friability, erosion, ulceration, bleeding, and mucus retention, will be recorded. |
Countries
China
Outcome results
None listed