The Impact of Probiotic Intervention on the Gut Microbiota and Bowel Function
1 other identifier
interventional
156
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2025
CompletedFirst Submitted
Initial submission to the registry
December 23, 2025
CompletedFirst Posted
Study publicly available on registry
January 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
January 27, 2026
January 1, 2026
3.5 years
December 23, 2025
January 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Low Anterior Resection Syndrome Score（LARS Score）
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.
One month after stoma reversal
microbial diversity
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
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.
Secondary Outcomes (4)
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
Study Arms (3)
high dose group
EXPERIMENTALthe 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
low dose group
EXPERIMENTALthe 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
control group
NO INTERVENTIONthe control group received routine postoperative follow-up
Interventions
Clostridium butyricum (live) Tablet administered into the dysfunctional intestine for low dose and high dose group, while control group has no intervention
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- History of neurological or psychiatric disorders, including but not limited to Parkinson's disease, Alzheimer's disease, organic brain diseases, stroke, epilepsy, or major psychiatric disorders (e.g., major depressive disorder)
- Pregnant or lactating women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhongnan Hospitalcollaborator
- The First Affiliated Hospital of Nankai Universitycollaborator
- First Affiliated Hospital of Fujian Medical Universitycollaborator
- Ruijin Hospitalcollaborator
- Nanfang Hospital, Southern Medical Universitcollaborator
- Huashan Hospitallead
- Characteristic Medical Center of Rocket Armycollaborator
Study Sites (1)
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiang Jianbin, Doctor
Huashan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 23, 2025
First Posted
January 27, 2026
Study Start
October 15, 2025
Primary Completion (Estimated)
March 30, 2029
Study Completion (Estimated)
June 30, 2029
Last Updated
January 27, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available beginning 9 months and ending 36 months after article publication.
- Access Criteria
- De-identified individual participant data will be available to qualified researchers whose proposals have been approved by an independent data access committee. Requestors must submit a scientifically sound research proposal and sign a data use agreement.
De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be shared. The study protocol, statistical analysis plan, and informed consent form will also be available. Data will be available beginning 9 months and ending 36 months after article publication. Proposals for data access should be directed to the corresponding author. To gain access, data requestors will need to sign a data access agreement. Data will be provided via a secure online platform.