Fecal Microbiota Transplantation
Conditions
Brief summary
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.
Interventions
PROCEDUREFMT capsule
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.
Sponsors
Shanghai 10th People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* The patients (aged 50-85 years) exhibited cognitive decline persisting for over six months; * Primarily characterized by recent memory impairment and accompanied by reduced daily living abilities; * MMSE scores ranging from 3 to 26; * MRI findings revealed atrophy in the medial temporal lobe, hippocampus, and cerebral cortex, along with widened sulci and fissures.
Exclusion criteria
* Patients were excluded if they had severe visual, hearing, or language impairments; * Tumors; * hepatic/renal dysfunction. * with conditions mimicking AD symptoms-such as normal pressure hydrocephalus, vascular dementia (VD or VaD); * Parkinson's disease dementia (PDD)-were also excluded; * patients who had participated in clinical drug trials within the past 30 days or consumed folate and vitamin B12 at doses exceeding twice the recommended intake were ineligible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy endpoints | 0, 1month, 2months, 3months, 6months | Changes in scores on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) |
| Changes in gut microbiota | 0, 1month, 2months, 3month, 6months | 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. |
Countries
China
Outcome results
None listed