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

April 7, 2025 updated by: Huanlong Qin, Shanghai 10th People's Hospital

Clinical Safety and Efficacy of FMT in the Treatment of Alzheimer's Disease

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Le Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FMT
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy endpoints
Time Frame: 0, 1month, 2months, 3months, 6months
Changes in scores on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
0, 1month, 2months, 3months, 6months
Efficacy endpoints
Time Frame: 0, 1month, 2months, 3months, 6months
Changes in scores on Mini-Mental State Examination (MMSE).
0, 1month, 2months, 3months, 6months
Efficacy endpoints
Time Frame: 0, 1month, 2months, 3months, 6months
Changes in scores on Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADAS-CGIC).
0, 1month, 2months, 3months, 6months
Efficacy endpoints
Time Frame: 0, 1month, 2months, 3months, 6months
Changes in scores on Alzheimer's Disease Activities of Daily Living Scale (ADAS-ADL)
0, 1month, 2months, 3months, 6months
Changes in gut microbiota
Time Frame: 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.
0, 1month, 2months, 3month, 6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 10th People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 31, 2025

First Submitted That Met QC Criteria

April 7, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMT-AD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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