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Trial Title:
Alterations of Gut Microbiome, Function, and Its Intervention After Defunctioning Ileostomy
NCT ID:
NCT05759741
Condition:
Ileostomy - Stoma
Rectal Cancer
Microbial Disease
Intestinal Functional Disorder
Conditions: Official terms:
Rectal Neoplasms
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
MIYAIRI 588
Description:
4 tablets of MIYAIRI 588 were inserted into the distal ileostomy once a week for 6 months
Arm group label:
MIYAIRI 588 group
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Huashan hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianbin Xiang
Phone:
52887040
Email:
xjbzhw@163.com
Start date:
January 17, 2023
Completion date:
July 17, 2024
Lead sponsor:
Agency:
Huashan Hospital
Agency class:
Other
Source:
Huashan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05759741
