Faecal microbiota transplantation to change gut flora in people with Alzheimer's disease
Alzheimer's Disease and Faecal Microbiota Transplantation
This pilot tests whether a donor stool transplant given during a colonoscopy is safe and feasible for people with mild-to-moderate Alzheimer's disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital of North Norway Academic / other |
| Locations | 1 site (Tromsø, Troms) |
| Trial ID | NCT07332260 on ClinicalTrials.gov |
What this trial studies
This Phase 1 pilot at the University Hospital of North Norway uses preprocessed donor stool (FMT) delivered during colonoscopy to modify gut microbiota in people with biomarker-confirmed mild-to-moderate Alzheimer's disease. The main goals are to determine safety and feasibility rather than clinical efficacy. Participants are screened with colonoscopy and MRI and must meet multiple exclusion criteria (for example, immunocompromise, recent major GI surgery, anticoagulant use, or severe frailty). Follow-up includes clinical monitoring for adverse events and feasibility measures related to the procedure and participant tolerability.
Who should consider this trial
Good fit: Ideal candidates are adults with mild-to-moderate Alzheimer's dementia who can give informed consent and have biomarker-confirmed AD and are eligible for colonoscopy and MRI.
Not a fit: Patients with severe dementia, major psychiatric illness, active substance abuse, significant cardiac disease, immunosuppression, recent colectomy, active colitis, large colonic adenomas, or on contraindicated anticoagulation are excluded and unlikely to receive benefit from this intervention.
Why it matters
Potential benefit: If successful, this could lead to a new way to improve symptoms or slow cognitive decline by restoring healthier gut microbiota.
How similar studies have performed: The approach is largely novel for Alzheimer's disease: animal models and small, early human reports suggest possible effects of gut microbiota on brain disease, but there is no definitive clinical evidence of success in AD yet.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tromsø, Troms
- University Hospital of North Norway, Tromsø — Tromsø, Troms, Norway (Recruiting)
Study contacts
- Principal investigator: Mona Dixon Gundersen, MBChB, PhD — University Hospital of North Norway, Tromsø
- Study coordinator: Mona Dixon Gundersen, MBChB, PhD
- Email: mona.dixon.gundersen@unn.no
- Phone: +47 77798916
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.