Crohn Disease Clinical Trial
Official title:
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Crohn's Disease
NCT number | NCT04100005 |
Other study ID # | PRG-008 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 2, 2020 |
Est. completion date | July 2023 |
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Crohn's disease.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | July 2023 |
Est. primary completion date | March 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 age 12 and older. (interest is given to children 12 and older to compare with mothers). 3. Diagnosis of Non-Fistulating Crohn's disease confirmed by at least one of the following 1. Colonoscopy 2. Capsule Endoscopy 3. Computerized Tomography (CT) Scan 4. Magnetic Resonance Imaging (MRI) 5. Balloon-assisted enteroscopy Exclusion Criteria: 1. Refusal to sign informed consent form 2. Presence of Fistulating Crohn's disease 3. Treatment with antibiotics within 2 weeks prior to screening 4. Treatment with probiotics within 6 weeks prior to screening. 5. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 6. Postoperative stoma, ostomy, or ileoanal pouch 7. Participation in any experimental drug protocol within the past 12 weeks 8. Treatment with total parenteral nutrition 9. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial 10. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study |
Country | Name | City | State |
---|---|---|---|
United States | ProgenaBiome | Ventura | California |
Lead Sponsor | Collaborator |
---|---|
ProgenaBiome |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation of Microbiome to Crohn's 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. | 1 year | |
Secondary | Validation of Sequencing Methods | To validate the methods used to sequence samples | 1 year |
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