A Pilot Study to Explore the Role of Gut Flora in Crohn's Disease
Withdrawn before enrolling
Conditions studied: Crohn Disease, Crohn Colitis, Crohn's Ileocolitis, Crohn Ileitis, Crohn Disease of Ileum, Crohn's Disease Relapse, Crohn's Gastritis, Crohns Disease Aggravated, Crohn Disease in Remission, Crohn's Jejunitis, Crohn's Duodenitis, Crohn's Disease of Pylorus, Crohn's Esophagitis, Crohn's
In brief
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Crohn's disease.
Key facts
- Study ID
- NCT04100005
- Run by
- ProgenaBiome
- People needed
- 0
- Starts
- 2020-03-02
- Expected to finish
- 2030-07-01
- Last updated by the study team
- 2025-06-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- ProgenaBiome — Ventura, California, United States
Full record on ClinicalTrials.gov
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