Status:
WITHDRAWN
A Pilot Study to Explore the Role of Gut Flora in Crohn's Disease
Lead Sponsor:
ProgenaBiome
Conditions:
Crohn Disease
Crohn Colitis
Eligibility:
All Genders
18+ years
Brief Summary
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Crohn'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 Crohn's d...
Eligibility Criteria
Inclusion
- Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
- Male or female patients age 12 and older. (interest is given to children 12 and older to compare with mothers).
- Diagnosis of Non-Fistulating Crohn's disease confirmed by at least one of the following
- Colonoscopy
- Capsule Endoscopy
- Computerized Tomography (CT) Scan
- Magnetic Resonance Imaging (MRI)
- Balloon-assisted enteroscopy
Exclusion
- Refusal to sign informed consent form
- Presence of Fistulating Crohn's disease
- Treatment with antibiotics within 2 weeks prior to screening
- Treatment with probiotics within 6 weeks prior to screening.
- History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
- Postoperative stoma, ostomy, or ileoanal pouch
- Participation in any experimental drug protocol within the past 12 weeks
- Treatment with total parenteral nutrition
- Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
- 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 :
March 2 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2030
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04100005
Start Date
March 2 2020
End Date
July 1 2030
Last Update
June 5 2025
Active Locations (1)
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1
ProgenaBiome
Ventura, California, United States, 93003