ClinicalTrials.Veeva

Menu

Alterations of Gut Microbiome, Function, and Its Intervention After Defunctioning Ileostomy

Fudan University logo

Fudan University

Status and phase

Enrolling
Early Phase 1

Conditions

Ileostomy - Stoma
Microbial Disease
Intestinal Functional Disorder
Rectal Cancer

Treatments

Drug: MIYAIRI 588

Study type

Interventional

Funder types

Other

Identifiers

NCT05759741
KY2022-1095

Details and patient eligibility

About

This study focused on the alterations of gut microbiome and function during defunctioning ileostomy, and observed the effects of probiotic intervention on intestinal microbiome and function. The investigators looked forward to find the specific intestinal maladjusted flora from this work, which could provide a new scheme for the subsequent treatment of the damaged intestinal function and the reduction of the incidence of postoperative complication.

Enrollment

64 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patients with primary rectal cancer received total mesolectal resection combined with defunctioning ileostomy.
  2. Patients voluntarily sign informed consent.

Exclusion criteria

  1. Disease progression or death after surgery.
  2. Patients with inflammatory bowl disease.
  3. Patients need to be on antibiotics/other probiotics for a long time.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

64 participants in 2 patient groups

MIYAIRI 588 group
Experimental group
Description:
4 tablets of MIYAIRI 588 were inserted into distal ileostomy once a week for 6 months.
Treatment:
Drug: MIYAIRI 588
control group
No Intervention group
Description:
The anastomosis stoma was followed up monthly in the outpatient department

Trial contacts and locations

1

Loading...

Central trial contact

Jianbin Xiang; Xiaodong Gu

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems