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

NCT ID: NCT06920212

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-12-31

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.

Conditions

Fecal Microbiota Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FMT

Group Type: EXPERIMENTAL

FMT capsule

Intervention Type: 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.

Interventions

FMT 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 10th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Huanlong Qin

Dean of the hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Le Wang

Shanghai, , China

Countries

China

Other Identifiers

FMT-AD

Identifier Type: -

Identifier Source: org_study_id