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

Launched by PROGENABIOME · Jul 23, 2019

Keywords

ClinConnect Summary

This clinical trial is exploring the role of gut bacteria, known as the gut microbiome, in health and disease. Researchers want to understand how the information gathered from analyzing these bacteria relates to what patients share about their health and their medical history. By comparing the data collected from patients with their health information, the study aims to uncover more about the connection between gut bacteria and various gastrointestinal issues.

Anyone interested in participating must be willing to sign a consent form that shows they understand the study and its procedures. The trial welcomes both men and women of all ages, especially children, so researchers can compare their microbiomes to those of their mothers. However, certain individuals, such as those who have had specific types of surgeries or who are currently in other drug studies, may not be eligible. Participants will provide samples and share information about their health, helping scientists learn more about gut health, which could lead to better treatments in the future.

Gender

ALL

Eligibility criteria

• 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