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

ProgenaBiome

Overview

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

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Crohn's disease.

Study Type

OBSERVATIONAL

Conditions

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

Interventions

No interventionOTHER

There is no intervention for this study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

ProgenaBiome

Ventura, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

Validation of Sequencing Methods

To validate the methods used to sequence samples

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.