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

Sponsor
Huashan Hospital
Study ID
NCT07369830
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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 Details

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.

Key Dates

First listed
Jan 27, 2026
Start date
Oct 15, 2025
Status verified
Jan 2026
Primary completion
Mar 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
156 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Experimental: 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
  • No Intervention: control group
    the control group received routine postoperative follow-up

Primary Outcome Measure

Low Anterior Resection Syndrome Score（LARS Score） [ Time Frame: One month after stoma reversal ]

Central Contacts

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