Fecal Microbiota TransplantationNCT06920212
Clinical Safety and Efficacy of Fecal Microbiota Transplantation (FMT) in the Treatment of Alzheimer's Disease
A study testing FMT capsule in people with Fecal Microbiota Transplantation, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
To investigate the clinical safety and efficacy of FMT in AD patients, as well as the changes in the gut microbiota of AD patients before and after FMT. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Fecal Microbiota Transplantation
- What is being tested?
- FMT capsule
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients (aged 50-85 years) exhibited cognitive decline persisting for over six months;
- Primarily characterized by recent memory impairment and accompanied by reduced daily living abilities;
- MMSE scores ranging from 3 to 26;
- MRI findings revealed atrophy in the medial temporal lobe, hippocampus, and cerebral cortex, along with widened sulci and fissures.
Who cannot join
- Patients were excluded if they had severe visual, hearing, or language impairments;
- Tumors;
- hepatic/renal dysfunction.
- with conditions mimicking AD symptoms-such as normal pressure hydrocephalus, vascular dementia (VD or VaD);
- Parkinson's disease dementia (PDD)-were also excluded;
- patients who had participated in clinical drug trials within the past 30 days or consumed folate and vitamin B12 at doses exceeding twice the recommended intake were ineligible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Safety and Efficacy of FMT in the Treatment of Alzheimer's Disease
To investigate the clinical safety and efficacy of FMT in AD patients, as well as the changes in the gut microbiota of AD patients before and after FMT.
- Conditions
- Fecal Microbiota Transplantation
- Being tested
- FMT capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMT capsuleProcedure or surgery
Fecal microbiota transplantation (FMT) is a method for treating imbalances in the intestinal microbiota. Its basic principle involves extracting a portion of feces from a healthy individual that contains a diverse population of beneficial bacteria, processing it, and transplanting it into the digestive system of the recipient to restore a balanced intestinal microbiota.
| Study group | Role | What they receive |
|---|---|---|
| FMT | Experimental | Not described Receives: Procedure: FMT capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy endpoints
Changes in scores on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Measured: 0, 1month, 2months, 3months, 6months
Efficacy endpoints
Changes in scores on Mini-Mental State Examination (MMSE).
Measured: 0, 1month, 2months, 3months, 6months
Efficacy endpoints
Changes in scores on Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADAS-CGIC).
Measured: 0, 1month, 2months, 3months, 6months
Efficacy endpoints
Changes in scores on Alzheimer's Disease Activities of Daily Living Scale (ADAS-ADL)
Measured: 0, 1month, 2months, 3months, 6months
Changes in gut microbiota
Gut metagenomic sequencing was performed to conduct OTU (Operational Taxonomic Unit) clustering and taxonomic analysis, comparing alterations in patients' intestinal flora before and after FMT.
Measured: 0, 1month, 2months, 3month, 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Oct 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal Microbiota TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huanlong Qin, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920212
- Sponsor's protocol ID
- FMT-AD
- Status last verified
- Apr 2025
- First submitted
- 31 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Safety and Efficacy of FMT in the Treatment of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06920212
- Acronym / sponsor ID
- FMT-AD
- Conditions
- Fecal Microbiota Transplantation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the clinical safety and efficacy of FMT in AD patients, as well as the changes in the gut microbiota of AD patients before and after FMT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMT | Experimental | Procedure: FMT capsule |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patients (aged 50-85 years) exhibited cognitive decline persisting for over six months;
- Primarily characterized by recent memory impairment and accompanied by reduced daily living abilities;
- MMSE scores ranging from 3 to 26;
- MRI findings revealed atrophy in the medial temporal lobe, hippocampus, and cerebral cortex, along with widened sulci and fissures.
Key exclusion criteria (6 listed)
- Patients were excluded if they had severe visual, hearing, or language impairments;
- Tumors;
- hepatic/renal dysfunction.
- with conditions mimicking AD symptoms-such as normal pressure hydrocephalus, vascular dementia (VD or VaD);
- Parkinson's disease dementia (PDD)-were also excluded;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FMT capsuleFecal microbiota transplantation (FMT) is a method for treating imbalances in the intestinal microbiota. Its basic principle involves extracting a portion of feces from a healthy individual that contains a diverse population of beneficial bacteria, processing it, and transplanting it into the digestive system of the recipient to restore a balanced intestinal microbiota. | Procedure or surgery | FMT |
Primary outcome
Efficacy endpoints
Time frame: 0, 1month, 2months, 3months, 6months
Changes in scores on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Efficacy endpoints
Time frame: 0, 1month, 2months, 3months, 6months
Changes in scores on Mini-Mental State Examination (MMSE).
Efficacy endpoints
Time frame: 0, 1month, 2months, 3months, 6months
Changes in scores on Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADAS-CGIC).
Efficacy endpoints
Time frame: 0, 1month, 2months, 3months, 6months
Changes in scores on Alzheimer's Disease Activities of Daily Living Scale (ADAS-ADL)
Changes in gut microbiota
Time frame: 0, 1month, 2months, 3month, 6months
Gut metagenomic sequencing was performed to conduct OTU (Operational Taxonomic Unit) clustering and taxonomic analysis, comparing alterations in patients' intestinal flora before and after FMT.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FMT capsule in people with Fecal Microbiota Transplantation, run by Shanghai 10th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy endpoints (time frame: 0, 1month, 2months, 3months, 6months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.