A Pilot Study to Explore the Role of Gut Flora in Crohn's Disease
NCT ID: NCT04100005
Last Updated: 2025-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2020-03-02
2030-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Crohn's disease
Patients who have been diagnosed with Crohn's disease
No intervention
There is no intervention for this study.
Interventions
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No intervention
There is no intervention for this study.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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ProgenaBiome
OTHER
Responsible Party
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Principal Investigators
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Sabine Hazan, MD
Role: PRINCIPAL_INVESTIGATOR
ProgenaBiome
Locations
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ProgenaBiome
Ventura, California, United States
Countries
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Other Identifiers
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PRG-008
Identifier Type: -
Identifier Source: org_study_id
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