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

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

Detailed Description
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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.

Official Title
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A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Crohn's Disease

Conditions
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Crohn's, 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

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Crohn's disease<br>Patients who have been diagnosed with Crohn's disease | Other: No intervention<br>* There is no intervention for this study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of Sequencing Methods | To validate the methods used to sequence samples | 1 year |