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The goal of this clinical trial is to learn about effectiveness and safety of washing microbiota transplantation in diabetic gastrointestinal motility disorders participant population. The main questions it aims to answer are:
Participants will be collected fasting venous blood and random stool samples before treatment and at week 12 post-treatment, conducting scale assessments before treatment and at weeks 1, 4, and 12 post-treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Washing Microbiota Transplantation (WMT) group | Experimental | After assessing the general condition and gastrointestinal symptoms of the patients upon admission, consecutive days of washing microbiota transplantation were conducted. The administration time was 3 p.m., administered via a nasogastric tube at a dosage of 50 ml per administration. A follow-up appointment at the hospital was scheduled for week 12 post-treatment to reinforce the therapeutic effect with a second treatment, following the same timing, dosage, and administration route as the first treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Washing Microbiota Transplantation | Other | Fecal samples from healthy adults were collected and underwent multiple centrifugations and filtrations to obtain a bacterial solution, which was then transplanted into the duodenum of patients via a nasogastric tube. |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal Symptom Rating Scale | Questionnaires,the minimum score is 0,and maximum is 45, and higher scores mean a worse outcome. | 0 days,weeks 1, 4, and 12 post-treatment |
| Gut Microbiome Sequencing | 16S rRNA Sequencing | 0 days,weeks 12 post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Gastroparesis Cardinal Symptom Index | Questionnaires,the minimum score is 0,and maximum is 45, and higher scores mean a worse outcome. | 0 days,weeks 1, 4, and 12 post-treatment |
| Composite Autonomic Symptom Score 31 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sijing Wang, Master's student | Contact | +8615664579913 | 15664579913@163.com | |
| Dafa Ding, Professor | Contact | +8615850514014 | dingdafa@njmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210000 | China |
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Questionnaires,the minimum score is 0,and maximum is 75, and higher scores mean a worse outcome.
| 0 days,weeks 1, 4, and 12 post-treatment |
| Gastrointestinal Motility | Neurophysiological Method | 0 days,weeks 12 post-treatment |
| Heart Rate Variability | Neurophysiological Method | 0 days,weeks 12 post-treatment |
| Serum Metabolites | Liquid chromatography-mass spectrometry (LC-MS) | 0 days,weeks 12 post-treatment |
| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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