WithdrawnNot Applicable

A Pilot Study to Explore the Role of Gut Flora in Crohn's Disease

Stopped: Company focus shifted

United States0Started 2020-03-02

Plain-language summary

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Crohn's disease.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

Correlation of Microbiome to Crohn's Disease via Relative Abundance Found in Microbiome Sequencing

Timeframe: 1 year

NCT IDNCT04100005

SponsorProgenaBiome

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-03