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This is a randomized controlled trial to explore the exploring the non-inferiority of CMTS0515-augmented WMT compared to WMT.
At least 60 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. They will be randomly assigned to the experimental group (CMTS0515-augmented WMT) and the control group (WMT). Data of demographic characteristics, intestinal symptoms, medicine treatment usage and clinical outcomes will be collected. After treatment, they will enter the follow-up period for efficacy and safety evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMTS0515-augmented washed microbiota transplantation | Experimental | Patients undergo CMTS0515-augmented washed microbiota transplantation once a day for three consecutive days. |
|
| washed microbiota transplantation | Active Comparator | Patients undergo washed microbiota transplantation once a day for three consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMTS0515-augmented washed microbiota transplantation | Other | Lyophilized CMTS0515 is added to washed microbiota suspension and administered via mid-gut or colonic transendoscopic enteral tube. |
| Measure | Description | Time Frame |
|---|---|---|
| The clinical response rate after treatment | Radiation Therapy Oncology Group (RTOG) scores | 1 week, 4 weeks and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Scores of gastrointestinal symptoms | Gastrointestinal symptoms will be evaluated according to NCI-CTC 5.0 | 1 week, 4 weeks and 8 weeks |
| Stool frequency and consistency | Stool frequency and consistency will be evaluated according to The Bristol Stool Form Scale (BSFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Microbiota Medicine & Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210011 | China |
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| Washed Microbiota Transplantation | Other | Washed microbiota suspension delivered through mid-gut and lower-gut transendoscopic enteral tube. |
|
| 1 week, 4 weeks and 8 weeks |