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

March 12, 2023 updated by: Jianbin Xiang, Huashan Hospital

Alterations of Gut Microbiome, Function, and Its Intervention After Total Mesorectal Excision With Defunctioning Ileostomy for Mid-low Rectal Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Huashan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wexner incontinence score
Time Frame: 1 year
Assess defecation function，the score range is 0-20, 0 is normal, 20 is complete incontinence
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fecal incontinence quality-of-life scale
Time Frame: 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.
1 year
Rate of postoperative complications
Time Frame: 1 month after operation
Such as anastomotic leakage, operative death, intestinal obstruction, intestinal infection，etc.
1 month after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2023

Primary Completion (Anticipated)

July 17, 2024

Study Completion (Anticipated)

July 17, 2024

Study Registration Dates

First Submitted

February 12, 2023

First Submitted That Met QC Criteria

February 26, 2023

First Posted (Actual)

March 8, 2023

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 12, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2022-1095

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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