A Pilot Study to Explore the Role of Gut Flora in Crohn's Disease
Reason given: Company focus shifted
Key facts
- Where
- Ventura, United StatesSee the site
Where in United States
- ProgenaBiomeVentura, United StatesNo longer taking part
Trial details
- Who runs it
- ProgenaBiome
- Trial code
- NCT04100005
- Record updated
- 5 June 2025
- Original description
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Crohn's disease.Read full original descriptionShow less
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Crohn's Disease
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Crohn's disease.
Inclusion: 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: Treatment with antibiotics within 2 weeks prior to screening; Treatment with probiotics within 6 weeks prior to screening; Participation in any experimental drug protocol within the past 12 weeks; Treatment with total parenteral nutrition; Presence of Fistulating Crohn's disease; History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy; Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial; Refusal to sign informed consent form; Postoperative stoma, ostomy, or ileoanal pouch; Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study.