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Recruiting Phase 1 NCT07332260

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

Phase 1 – testing safety in a small group of people
Conditions: Alzheimer s Disease Faecal Microbiota Transplantation (FMT)

Sponsor: University Hospital of North Norway

trial.available_in: БГ
Overview
The goal of this study is to assess the feasibility and safety of faecal microbiota transplantation for Alzheimer's disease.
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.
Who can participate
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
Interventions
Biological: Preprocessed thawed donor FMT
BIOLOGICAL
Locations 1
Norway (1)
University Hospital of North Norway, Tromsø
Tromsø , Troms
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.05.2026
Completion date
01.01.2027
Registry ID
NCT07332260
Source
clinicaltrials.gov
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