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A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Alzheimer's Disease

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Alzheimer's Disease

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04100889
Enrollment
0
Registered
2019-09-24
Start date
2020-03-02
Completion date
2030-07-31
Last updated
2025-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Alzheimer Disease 1, Alzheimer Disease 10, Alzheimer Disease 11, Alzheimer Disease 12, Alzheimer Disease 13, Alzheimer Disease 14, Alzheimer Disease 15, Alzheimer Disease 16, Alzheimer Disease 17, Alzheimer Disease 18, Alzheimer Disease 19, Alzheimer Disease 2, Alzheimer Disease 3, Alzheimer Disease 4, Alzheimer Disease 5, Alzheimer Disease 6, Alzheimer Disease 7, Alzheimer Disease 8, Alzheimer Disease 9, Late-Onset, Alzheimer Disease, Early Onset, Alzheimer Disease Focal, Alzheimer Disease, Late Onset

Keywords

Microbiome

Brief summary

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Alzheimer's disease.

Detailed description

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Alzheimer's disease.

Interventions

OTHERNo Intervention

There is no intervention for this study.

Sponsors

ProgenaBiome
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study 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

1. Refusal to sign informed consent form 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

Design outcomes

Primary

MeasureTime frameDescription
Correlation of Microbiome to Alzheimer's Disease via Relative Abundance Found in Microbiome Sequencing1 yearRelative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be correlated to Alzheimer's disease state

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026