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To investigate the clinical safety and efficacy of FMT in AD patients, as well as the changes in the gut microbiota of AD patients before and after FMT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMT capsule | Procedure | Fecal microbiota transplantation (FMT) is a method for treating imbalances in the intestinal microbiota. Its basic principle involves extracting a portion of feces from a healthy individual that contains a diverse population of beneficial bacteria, processing it, and transplanting it into the digestive system of the recipient to restore a balanced intestinal microbiota. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy endpoints | Changes in scores on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) | 0, 1month, 2months, 3months, 6months |
| Efficacy endpoints | Changes in scores on Mini-Mental State Examination (MMSE). | 0, 1month, 2months, 3months, 6months |
| Efficacy endpoints | Changes in scores on Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADAS-CGIC). | 0, 1month, 2months, 3months, 6months |
| Efficacy endpoints | Changes in scores on Alzheimer's Disease Activities of Daily Living Scale (ADAS-ADL) | 0, 1month, 2months, 3months, 6months |
| Changes in gut microbiota | Gut metagenomic sequencing was performed to conduct OTU (Operational Taxonomic Unit) clustering and taxonomic analysis, comparing alterations in patients' intestinal flora before and after FMT. | 0, 1month, 2months, 3month, 6months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Le Wang | Shanghai | China |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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