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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIYAIRI 588 group | Experimental | 4 tablets of MIYAIRI 588 were inserted into distal ileostomy once a week for 6 months. |
|
| control group | No Intervention | The anastomosis stoma was followed up monthly in the outpatient department |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIYAIRI 588 | Drug | 4 tablets of MIYAIRI 588 were inserted into the distal ileostomy once a week for 6 months |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianbin Xiang | Contact | 52887040 | xjbzhw@163.com | |
| Xiaodong Gu | Contact | 52887040 | gxdgxd737@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan hospital | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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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.
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| Rate of postoperative complications | Such as anastomotic leakage, operative death, intestinal obstruction, intestinal infection,etc. | 1 month after operation |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |