A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Alzheimer's Disease
NCT ID: NCT04100889
Last Updated: 2025-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2020-03-02
2030-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Alzheimer's disease patients
Patients who have been diagnosed with Alzheimer's disease
No Intervention
There is no intervention for this study.
Interventions
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No Intervention
There is no intervention for this study.
Eligibility Criteria
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Inclusion Criteria
2. Male or female patients age 18 and older
3. Diagnosis of Alzheimer's disease or dementia by a physician
4. Mini Mental Status Exam score less than 26
Exclusion Criteria
2. Treatment with antibiotics within 2 weeks prior to screening
3. Treatment with probiotics within 2 weeks prior to screening
4. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
5. Postoperative stoma, ostomy, or ileoanal pouch
6. Participation in any experimental drug protocol within the past 12 weeks
7. Treatment with total parenteral nutrition
8. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
9. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
18 Years
ALL
No
Sponsors
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ProgenaBiome
OTHER
Responsible Party
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Principal Investigators
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Sabine Hazan, MD
Role: PRINCIPAL_INVESTIGATOR
ProgenaBiome
Locations
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ProgenaBiome
Ventura, California, United States
Countries
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Other Identifiers
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PRG-007
Identifier Type: -
Identifier Source: org_study_id
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