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

NCT ID: NCT05759741

Last Updated: 2023-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-17

Study Completion Date

2024-07-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ileostomy - Stoma Rectal Cancer Microbial Disease Intestinal Functional Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MIYAIRI 588 group

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

Group Type EXPERIMENTAL

MIYAIRI 588

Intervention Type DRUG

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

control group

The anastomosis stoma was followed up monthly in the outpatient department

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MIYAIRI 588

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jianbin Xiang

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Huashan hospital

Shanghai, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jianbin Xiang

Role: CONTACT

Xiaodong Gu

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jianbin Xiang

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KY2022-1095

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Microbiome and Rectal Cancer
NCT04223102 ACTIVE_NOT_RECRUITING NA