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

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)

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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