NCT07332260 · Phase 1 · RECRUITING

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

This small pilot study tests whether a faecal microbiota transplant, which moves processed gut bacteria from a healthy donor into a patient's colon, is feasible and safe for people with mild to moderate Alzheimer's dementia. It is a Phase 1 trial, an early step checking safety and practicality, not whether it works.

You may qualify if

  • 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

You're excluded if

  • 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

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-04-22

View full record on ClinicalTrials.gov

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