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

Early Phase 1

Recruiting

• Conditions: Ileostomy - Stoma; Rectal Cancer; Microbial Disease; Intestinal Functional Disorder
• Interventions: Drug: MIYAIRI 588

• Registration Number: NCT05759741
• Lead Sponsor: Huashan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-17
• Study First Submitted: 2023-02-12
• Study First Submitted QC: 2023-02-26
• Status Verified: 2023-03
• Study First Posted: 2023-03-08
• Last Update Submitted: 2023-03-12
• Last Update Posted: 2023-03-14
• Primary Completion: 2024-07-17
• Study Completion: 2024-07-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MIYAIRI 588 group	MIYAIRI 588	4 tablets of MIYAIRI 588 were inserted into distal ileostomy once a week for 6 months.

Primary Outcome Measures

Name	Time	Method
Wexner incontinence score	1 year	Assess defecation function，the score range is 0-20, 0 is normal, 20 is complete incontinence

Secondary Outcome Measures

Name	Time	Method
fecal incontinence quality-of-life scale	1 year	The Fecal Incontinence Quality of Life Scale is composed of a total of 29 items; these items form four scales: Lifestyle (10 items), Coping/Behavior (9 items), Depression/Self-Perception (7 items), and Embarrassment (3 items). The score of each scale is 1-4 points. The higher the score, the worse the quality of life.
Rate of postoperative complications	1 month after operation	Such as anastomotic leakage, operative death, intestinal obstruction, intestinal infection，etc.

Trial Locations

Locations (1)

Huashan hospital; 🇨🇳 Shanghai, China