Status:
SUSPENDED
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease
Lead Sponsor:
ProgenaBiome
Conditions:
Gut Microbiome
Gastrointestinal Microbiome
Eligibility:
All Genders
12+ years
Brief Summary
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 11 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 10 2030
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04031469
Start Date
July 11 2019
End Date
December 10 2030
Last Update
July 31 2025
Active Locations (1)
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1
Sabine Hazan
Ventura, California, United States, 93003