The Impact of Probiotic Intervention on the Gut Microbiota and Bowel Function of Patients With Prophylactic Ileostomy for Ultra Low Rectal Cancer -a Multicenter Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Huashan Hospital
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- Low Anterior Resection Syndrome Score（LARS Score）
Overview
Brief Summary
This study aims to propose a novel, easy-to-operate intervention strategy that effectively improves defecation function after stoma reversal and to assess its impact on the gut microbiota.The efficacy and safety of antegrade placement of probiotics into the distal deserted intestine during prophylactic stoma to improve bowel function after stoma reversal were evaluated through randomized controlled clinical trials.Observing the changes in gut microbiota during the prophylactic stoma period, the impact of probiotics on the structure of gut microbiota, and exploring the correlation between gut genera and bowel function after stoma reversal.
Detailed Description
This study includes patients with ultra low rectal cancer who underwent ISR（Intersphincteric Resection） and prophylactic ileostomy. Patients are randomly assigned to the low dose group,high dose group and the control group in a 1:1:1 ratio. The low dose group received interventions (4 Meiya pills, administered into the dysfunctional intestine once a week) starting 1 week after the ileostomy, the high dose group received interventions (4 Meiya pills, administered into the dysfunctional intestine twice a week) starting 1 week after the ileostomy, while the control group received routine postoperative follow-up. Evaluation indicators included bowel function and quality of life before the prophylactic ileostomy and 1 week, 2 weeks, 1 month, 3 months, and 6 months and so on until two years after the stoma reversal.
Fecal samples are collected prior to prophylactic ileostomy. Post-stoma reversal surgery, fecal samples are obtained from patients at their first defecation . All fecal samples underwent 16s rRNA gene sequencing and bioinformatic analysis to compare the microbial composition differences among three groups. Key genera associated with bowel function were identified through correlation analysis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 18 and 75 years
- •Ultra low rectal cancer meeting the indication for Intersphincteric Resection (ISR) surgery
- •Underwent a prophylactic ileostomy
- •Scheduled for stoma reversal surgery within 6 months after the ISR procedure
- •Digestive tract reconstruction achieved via either hand-sewn or stapled coloanal anastomosis
- •Patient has a strong preference for undergoing sphincter-preserving surgery
- •Capable of understanding and willing to provide signed informed consent
Exclusion Criteria
- •Does not meet the surgical indications for Intersphincteric Resection (ISR)
- •Presence of multiple primary colorectal malignancies
- •Patients who have received neoadjuvant radiotherapy
- •Patients who experience disease progression or death in the postoperative period
- •Patients who develop severe anastomotic complications postoperatively, such as anastomotic leakage or stenosis
- •Patients whose actual stoma reversal surgery occurs more than 6 months after the ISR procedure
- •Patients who require long-term(more than 3 months) use of antibiotics
- •History of allergy to Clostridium butyricum (live) Tablets (MIYA) or any of its components
- •Concurrent use of other probiotic during the study period
- •Coexisting inflammatory bowel disease
Arms & Interventions
high dose group
the high dose group received interventions (4 Clostridium butyricum (live) Tablets(Meiya), administered into the dysfunctional intestine twice a week) starting 1 week after the ileostomy
Intervention: Clostridium butyricum (live) Tablets(Meiya) (Biological)
low dose group
the low dose group received interventions (4 Clostridium butyricum (live) Tablets(Meiya), administered into the dysfunctional intestine once a week) starting 1 week after the ileostomy
Intervention: Clostridium butyricum (live) Tablets(Meiya) (Biological)
control group
the control group received routine postoperative follow-up
Outcomes
Primary Outcomes
Low Anterior Resection Syndrome Score（LARS Score）
Time Frame: One month after stoma reversal
Comparison of LARS scores among the three groups at one month postoperatively. Low Anterior Resection Syndrome (LARS) is characterized by major symptoms including difficulty defecating, urgency, incontinence of liquid stool, incontinence of flatus, and increased frequency of bowel movements. Based on severity, LARS can be classified as none (0-20 points), minor (21-29 points), or major (30-42 points) using LARS score. And higher scores mean a worse outcome.
microbial diversity
Time Frame: The first stool sample will be collected within one week before ISR surgery, and the second stool sample will be collected within three to five days after stoma reversal, upon the first bowel movement.
Fecal samples from study participants with ISR preoperatively and postoperatively will be collected to analyze the alpha and beta diversity of gut microbiota among the three groups
Secondary Outcomes
- Wexner Incontinence Score(one month after ISR)
- Kirwan Incontinence Score(one month after ISR)
- Exploratory LARS Scoring Instrument(one month after ISR)
- Fecal Incontinence Quality of Life (FIQL) Scale(one month after ISR)
Investigators
Jianbin Xiang
Principal Investigator
Huashan Hospital