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Recruiting NCT07369830

The Impact of Probiotic Intervention on the Gut Microbiota and Bowel Function

No phase Interventional Rectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clostridium butyricum (live) Tablets(Meiya).
Who it may be relevant to
Registry conditions: Rectal Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Biological 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

Primary outcome measures

  • Low Anterior Resection Syndrome Score（LARS Score） [Time frame: One month after stoma reversal]
  • 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.]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Huashan Hospital Fudan University — Shanghai

Identifiers

NCT: NCT07369830 · KY2025-1273

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗