Ileostomy - Stoma, Intestinal Functional Disorder, Microbial Disease, Rectal Cancer
Conditions
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.
Interventions
DRUGMIYAIRI 588
4 tablets of MIYAIRI 588 were inserted into the distal ileostomy once a week for 6 months
Sponsors
Huashan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wexner incontinence score | 1 year | Assess defecation function，the score range is 0-20, 0 is normal, 20 is complete incontinence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fecal incontinence quality-of-life scale | 1 year | 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 | 1 month after operation | Such as anastomotic leakage, operative death, intestinal obstruction, intestinal infection，etc. |
Countries
China
Contacts
Primary ContactJianbin Xiang
Backup ContactXiaodong Gu
Outcome results
None listed