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New treatment option for Rectal Cancer
Official title The Impact of Probiotic Intervention on the Gut Microbiota and Bowel Function
ClinicalTrials.gov ID: NCT07369830
What this study is testing
What is Clostridium butyricum (live) Tablets(Meiya)?
Clostridium butyricum (live) Tablets(Meiya) is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for rectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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
You likely can't join 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
See the full eligibility 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
- 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...
- Pregnant or lactating women
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.