Back to resultsAlterations of Gut Microbiome, Function, and Its Intervention After Defunctioning Ileostomy
Primary Purpose
Ileostomy - Stoma, Rectal Cancer, Microbial Disease
Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
MIYAIRI 588
Sponsored by
About this trial
This is an interventional treatment trial for Ileostomy - Stoma
Eligibility Criteria
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.
Sites / Locations
- Huashan hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
MIYAIRI 588 group
control group
Arm Description
4 tablets of MIYAIRI 588 were inserted into distal ileostomy once a week for 6 months.
The anastomosis stoma was followed up monthly in the outpatient department
Outcomes
Primary Outcome Measures
Wexner incontinence score
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
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
Such as anastomotic leakage, operative death, intestinal obstruction, intestinal infection，etc.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05759741
Brief Title
Alterations of Gut Microbiome, Function, and Its Intervention After Defunctioning Ileostomy
Official Title
Alterations of Gut Microbiome, Function, and Its Intervention After Total Mesorectal Excision With Defunctioning Ileostomy for Mid-low Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2023 (Actual)
Primary Completion Date
July 17, 2024 (Anticipated)
Study Completion Date
July 17, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ileostomy - Stoma, Rectal Cancer, Microbial Disease, Intestinal Functional Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MIYAIRI 588 group
Arm Type
Experimental
Arm Description
4 tablets of MIYAIRI 588 were inserted into distal ileostomy once a week for 6 months.
Arm Title
control group
Arm Type
No Intervention
Arm Description
The anastomosis stoma was followed up monthly in the outpatient department
Intervention Type
Drug
Intervention Name(s)
MIYAIRI 588
Intervention Description
4 tablets of MIYAIRI 588 were inserted into the distal ileostomy once a week for 6 months
Primary Outcome Measure Information:
Title
Wexner incontinence score
Description
Assess defecation function，the score range is 0-20, 0 is normal, 20 is complete incontinence
Time Frame
1 year
Secondary Outcome Measure Information:
Title
fecal incontinence quality-of-life scale
Description
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.
Time Frame
1 year
Title
Rate of postoperative complications
Description
Such as anastomotic leakage, operative death, intestinal obstruction, intestinal infection，etc.
Time Frame
1 month after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianbin Xiang
Phone
52887040
Email
xjbzhw@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaodong Gu
Phone
52887040
Email
gxdgxd737@163.com
Facility Information:
Facility Name
Huashan hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianbin Xiang
Phone
52887040
Email
xjbzhw@163.com
12. IPD Sharing Statement
Learn more about this trial
Alterations of Gut Microbiome, Function, and Its Intervention After Defunctioning Ileostomy
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