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

ProgenaBiome1,000 enrolled

Overview

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Gut Microbiome Gastrointestinal Microbiome Autism Autism Spectrum Disorder Autism Spectrum Disorder High-Functioning Alzheimer Disease Alzheimer Dementia (AD)Alzheimer Dementia

Eligibility

Sex: ALLMin age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 of any age (interest is given to children to compare with mothers). Exclusion Criteria: * 1\. Refusal to sign informed consent form * 2\. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. * 3\. Postoperative stoma, ostomy, or ileoanal pouch * 4\. Participation in any experimental drug protocol within the past 12 weeks * 5\. Treatment with total parenteral nutrition * 6\. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial * 7\. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Outcomes

Primary Outcomes

Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing

Relative 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 categorized among specific gastrointestinal disease types.

Time frame: One year

Secondary Outcomes

Validation of Sequencing Methods

To validate the methods used to sequence samples

Time frame: One year

Data from ClinicalTrials.gov

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