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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ileostomy - Stoma, Rectal Cancer, Microbial Disease, Intestinal Functional Disorder

Intervention / Treatment
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* Drug: MIYAIRI 588


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MIYAIRI 588 group<br>4 tablets of MIYAIRI 588 were inserted into distal ileostomy once a week for 6 months. | Drug: MIYAIRI 588<br>* 4 tablets of MIYAIRI 588 were inserted into the distal ileostomy once a week for 6 months<br>|
| No Intervention: control group<br>The anastomosis stoma was followed up monthly in the outpatient department | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wexner incontinence score | Assess defecation function，the score range is 0-20, 0 is normal, 20 is complete incontinence | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Rate of postoperative complications | Such as anastomotic leakage, operative death, intestinal obstruction, intestinal infection，etc. | 1 month after operation |