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

Sponsor

Huashan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05759741

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ileostomy - Stoma Rectal Cancer Microbial Disease Intestinal Functional Disorder	Drug: MIYAIRI 588	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 17, 2023

Anticipated Primary Completion Date :

Jul 17, 2024

Anticipated Study Completion Date :

Jul 17, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Wexner incontinence score [1 year]
Assess defecation function，the score range is 0-20, 0 is normal, 20 is complete incontinence

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Huashan hospital	Shanghai		China

Sponsors and Collaborators

Huashan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jianbin Xiang, Clinical Professor, Huashan Hospital

ClinicalTrials.gov Identifier:

NCT05759741

Other Study ID Numbers:

KY2022-1095

First Posted:

Mar 8, 2023

Last Update Posted:

Mar 14, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Rectal Neoplasms

Study Results

No Results Posted as of Mar 14, 2023