Faecal microbiota transplantation to change gut flora in people with Alzheimer's disease
Official title: Alzheimer's Disease and Faecal Microbiota Transplantation
Run by University Hospital of North Norway · NCT07332260 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | University Hospital of North Norway Academic / other |
| Locations | 1 site (Tromsø, Troms) |
| Status | Recruiting |
| Started | May 2026 |
| Main results expected | October 2026 |
| Study ends | January 2027 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT07332260 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.