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NCT Number: NCT06920212

Clinical Safety and Efficacy of Fecal Microbiota Transplantation (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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Fecal Microbiota Transplantation

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Le Wang

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Efficacy endpoints

    Time frame: 0, 1month, 2months, 3months, 6months

    Changes in scores on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)

  2. Efficacy endpoints

    Time frame: 0, 1month, 2months, 3months, 6months

    Changes in scores on Mini-Mental State Examination (MMSE).

  3. 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).

  4. Efficacy endpoints

    Time frame: 0, 1month, 2months, 3months, 6months

    Changes in scores on Alzheimer's Disease Activities of Daily Living Scale (ADAS-ADL)

  5. 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.

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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