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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05759741
• Other study ID #: KY2022-1095
• Status: Recruiting
• Phase: Early Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Ileostomy - Stoma
• Microbial Disease
• Rectal Cancer
• Rectal Neoplasms

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