NCT04100005WithdrawnNot Applicable
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Crohn's Disease
ProgenaBiome1 site in 1 country100 target enrollmentStarted: March 2, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Correlation of Microbiome to Crohn's Disease via Relative Abundance Found in Microbiome Sequencing
Study Overview
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 disease.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Correlation of Microbiome to Crohn's Disease via Relative Abundance Found in Microbiome Sequencing
Time Frame: 1 year
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.
Secondary Outcomes
- Validation of Sequencing Methods(1 year)
Investigators
Study Sites (1)
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