Clinical Safety and Efficacy of Fecal Microbiota Transplantation (FMT) in the Treatment of Alzheimer's Disease

Tongji University

Status

Active, not recruiting

Conditions

Fecal Microbiota Transplantation

Treatments

Procedure: FMT capsule

Study type

Interventional

Funder types

Other

Identifiers

NCT06920212

FMT-AD

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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.