Rectal CancerNCT07369830
The Impact of Probiotic Intervention on the Gut Microbiota and Bowel Function
A study testing Clostridium butyricum (live) Tablets(Meiya) in people with Rectal Cancer, run by Huashan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Clostridium butyricum (live) Tablets(Meiya)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2025to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040
Li Zhenyang, Doctor, +86-13764030915, 13764030915@163.com
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Rectal Cancer
- Being tested
- Clostridium butyricum (live) Tablets(Meiya)
- Keywords
- rectal cancer, intersphincteric resection, prophylactic ileostomy, probiotic intervention, bowel function
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clostridium butyricum (live) Tablets(Meiya)Biological
Clostridium butyricum (live) Tablet administered into the dysfunctional intestine for low dose and high dose group, while control group has no intervention
| Study group | Role | What they receive |
|---|---|---|
| high dose group | Experimental | 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 Receives: Biological: Clostridium butyricum (live) Tablets(Meiya) |
| low dose group | Experimental | 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 Receives: Biological: Clostridium butyricum (live) Tablets(Meiya) |
| control group | No intervention | the control group received routine postoperative follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
The Wexner Incontinence Score (WIS) assesses the severity of incontinence from five aspects: solid stool incontinence, liquid stool incontinence, flatus incontinence, pad usage, and lifestyle alterations. The score ranges from 0 to 20, where 0 represents normal and 20 represents complete incontinence.
Measured: one month after ISR
Kirwan Incontinence Score
This grading system classifies anal incontinence into five grades (I-V) based on symptom severity: Grade I: No incontinence; Grade II: Incontinence to flatus or liquid stool; Grade III: Occasional solid stool incontinence; Grade IV: Frequent solid stool incontinence; Grade V: Requires a stoma (fecal diversion). Among these, Grades I-II indicate good continence function, while Grades III-IV indicate poor continence function.
Measured: one month after ISR
Exploratory LARS Scoring Instrument
An exploratory scoring instrument was used to determine the severity of 16 specific variables that were identified by the Delphi consensus for defining LARS. In accordance with the response range defined by the WIS, there were 5 frequency options ranging from never (meaning no episodes; score 0) to always (meaning 1 or more episodes/day; score 4) for each item. Given that social and psychological features (marital separation, divorce, widowed seniors, etc) may have an influence on "relationships and intimacy," its response category for "never" was replaced with dichotomous options of "none" and "N/A." The summary score, also called the Delphi consensus severity score, was used as an index for patient-reported severity of LARS, ranging from 0 (best) to 64 (worst).
Measured: one month after ISR
Fecal Incontinence Quality of Life (FIQL) Scale
The Fecal Incontinence Quality-of-Life (FIQL) Scale was used to analyze CSQoL. The FIQL entails 29 items that cover 4 domains: lifestyle (10 items), coping/behavior (9 items), depression/self-perception (7 items), and embarrassment (3 items).19 Each item has a range of 1 to 4 (except 2 items in depression/self-perception with ranges of 1-5 and 1-6). The score for each domain is the average of all items within its domain, and the global score is the mean of all domains. Higher scores indicate better CSQoL.
Measured: one month after ISR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start15 Oct 2025
- Primary completion30 Mar 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- 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
- Model description
- 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 the control group received routine postoperative follow-up
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Characteristic Medical Center of Rocket Army, Zhongnan Hospital, The Affiliated People's Hospital of Nankai University, First Affiliated Hospital of Fujian Medical University, Ruijin Hospital, Nanfang Hospital, Southern Medical University
- Responsible party
- Principal investigator, Jianbin Xiang, Huashan Hospital
- Investigators
- Xiang Jianbin, Doctor, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369830
- Sponsor's protocol ID
- KY2025-1273
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07369830
- Acronym / sponsor ID
- KY2025-1273
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, intersphincteric resection, prophylactic ileostomy, probiotic intervention, bowel function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Characteristic Medical Center of Rocket Army, Zhongnan Hospital, The Affiliated People's Hospital of Nankai University, First Affiliated Hospital of Fujian Medical University, Ruijin Hospital, Nanfang Hospital, Southern Medical University
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 27 Jan 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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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 the control group received routine postoperative follow-up
| Arm | Type | Receives |
|---|---|---|
| high dose group | Experimental | Biological: Clostridium butyricum (live) Tablets(Meiya)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 |
| low dose group | Experimental | Biological: Clostridium butyricum (live) Tablets(Meiya)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 |
| control group | No intervention | –the control group received routine postoperative follow-up |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Clostridium butyricum (live) Tablets(Meiya)Clostridium butyricum (live) Tablet administered into the dysfunctional intestine for low dose and high dose group, while control group has no intervention | Biological | high dose group, low dose group |
Primary outcome
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
4 secondary outcomes
Wexner Incontinence Score
Time frame: one month after ISR
Kirwan Incontinence Score
Time frame: one month after ISR
Exploratory LARS Scoring Instrument
Time frame: one month after ISR
Fecal Incontinence Quality of Life (FIQL) Scale
Time frame: one month after ISR
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
Xiang Jianbin, Doctor principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clostridium butyricum (live) Tablets(Meiya) in people with Rectal Cancer, run by Huashan Hospital 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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 27 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LI Zhenyang, Doctor (+86-13764030915, 13764030915@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low Anterior Resection Syndrome Score（LARS Score） (time frame: One month after stoma reversal). 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?
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 27 Jan 2026.