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

NCT05759741 | Unknown Early Phase 1

• 1 other identifier: KY2022-1095
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Ileostomy - Stoma; Rectal Cancer; Microbial Disease; Intestinal Functional Disorder

Outcome Measures

Primary Outcomes (1)

• Wexner incontinence score

  Assess defecation function，the score range is 0-20, 0 is normal, 20 is complete incontinence

  1 year

Secondary Outcomes (2)

• fecal incontinence quality-of-life scale

  1 year

• Rate of postoperative complications

  1 month after operation

Study Arms (2)

MIYAIRI 588 group

EXPERIMENTAL

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

Drug: MIYAIRI 588

control group

NO INTERVENTION

The anastomosis stoma was followed up monthly in the outpatient department

Interventions

MIYAIRI 588 DRUG

4 tablets of MIYAIRI 588 were inserted into the distal ileostomy once a week for 6 months

MIYAIRI 588 group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Jianbin Xiang

CONTACT

52887040; xjbzhw@163.com

Xiaodong Gu

CONTACT

52887040; gxdgxd737@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: The intervention group was given probiotics: 4 tablets of MIYAIRI 588, inserted into the distal ileostomy, once a week. The control group was not given drugs, only monthly outpatient follow-up of the anastomosis stoma.

Study Record Dates

• First Submitted: February 12, 2023
• First Posted: March 8, 2023
• Study Start: January 17, 2023
• Primary Completion: July 17, 2024
• Study Completion: July 17, 2024
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

CN (1)