Alzheimer's Disease and Faecal Microbiota Transplantation -a Pilot Study

NCT ID: NCT07332260

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-01-31

Brief Summary

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

Detailed 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.

Conditions

Alzheimer s Disease; Faecal Microbiota Transplantation (FMT)

Study Design

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

Study Groups

Faecal microbiota transplantation (FMT)

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

Group Type: EXPERIMENTAL

Biological: Preprocessed thawed donor FMT

Intervention Type: BIOLOGICAL

Biological: Preprocessed FMT solution is administered to the right side of the colon during a colonoscopy.

Interventions

Biological: Preprocessed thawed donor FMT

Biological: Preprocessed FMT solution is administered to the right side of the colon during a colonoscopy.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UiT The Arctic University of Norway

OTHER

Sponsor Role: collaborator

University Hospital of North Norway

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mona Dixon Gundersen, MBChB, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of North Norway, Tromsø

Central Contacts

Mona Dixon Gundersen, MBChB, PhD

Role: CONTACT

mona.dixon.gundersen@unn.no

+47 77798916

Other Identifiers

853867/2025

Identifier Type: -

Identifier Source: org_study_id