Alzheimer's Disease and Faecal Microbiota Transplantation -a Pilot Study (AD-FMT)

University Hospital of North Norway

Status and phase: Not yet enrolling; Phase 1

Conditions: Alzheimer s Disease; Faecal Microbiota Transplantation (FMT)

Treatments: Biological: Biological: Preprocessed thawed donor FMT

Study type: Interventional

Funder types: Other

Identifiers

NCT07332260

853867/2025

Details and patient eligibility

About

The goal of this study is to assess the feasibility and safety of faecal microbiota transplantation for Alzheimer's disease.

Full description

Alzheimer's disease (AD) is the most common cause of dementia.

Studies suggest that the gut flora may play a role in the development and/or progression of AD. The gut flora is found to be different in AD compared to healthy individuals. There is also support for a link between the gut flora and diseases affecting the brain, including AD.

Stool transplantation is an established medical treatment for Clostridioides difficile infections by restoring the balance of the gut flora. In this study, gut flora (a stool solution) is transferred from a healthy individual to an individual with AD. The stool transplantation is given during a colonoscopy examination of the large bowel.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Alzheimer's dementia mild to moderate stage
• Presence of Alzheimer pathology core 1 biomarkers as defined by National Institute on Aging-Alzheimer's Association (NIA-AA) criteria (2024)
• Capable of giving informed consent

Exclusion criteria

• Contraindications for colonoscopy examination
• Contraindications for Magnetic Resonance Imaging (MRI)
• Life expectancy < 1 year
• Clinical frailty scale 7 or more
• History of seizure disorder
• History of brain tumour or intracranial bleed
• Major psychiatric disorder such as schizophrenia, bipolar disorder, or major depressive disorder
• Alcohol or substance abuse
• Decompensated heart disease
• Malignancy
• Current use of anticoagulant treatment (dual acting oral anticoagulant or warfarin)
• Pregnant or planning pregnancy
• Colonic adenomas over 1 cm, tumours or signs of active colitis on colonoscopy
• Status after colectomy or hemicolectomy
• Inflammatory bowel disease
• Immunocompromised individual
• Receiving biological/antibody treatment

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Faecal microbiota transplantation (FMT)

Experimental group

Description:

Single-group, single-centre, open-label. Intervention: Faecal microbiota transplantation administered via colonoscopy to the right side of the colon.

Treatment:

Biological: Biological: Preprocessed thawed donor FMT