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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05759741
Other study ID # KY2022-1095
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date January 17, 2023
Est. completion date July 17, 2024

Study information

Verified date March 2023
Source Huashan Hospital
Contact Jianbin Xiang
Phone 52887040
Email xjbzhw@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date July 17, 2024
Est. primary completion date July 17, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
China Huashan hospital Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wexner incontinence score Assess defecation function,the score range is 0-20, 0 is normal, 20 is complete incontinence 1 year
Secondary 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. 1 year
Secondary Rate of postoperative complications Such as anastomotic leakage, operative death, intestinal obstruction, intestinal infection,etc. 1 month after operation
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