Crohn Colitis, Crohn Disease, Crohn Disease in Remission, Crohn Disease of Ileum, Crohn Ileitis, Crohn's, Crohns Disease Aggravated, Crohn's Disease of Pylorus, Crohn's Disease Relapse, Crohn's Duodenitis, Crohn's Esophagitis, Crohn's Gastritis, Crohn's Ileocolitis, Crohn's Jejunitis
Conditions
Brief summary
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Crohn's disease.
Detailed description
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.
Interventions
OTHERNo intervention
There is no intervention for this study.
Sponsors
ProgenaBiome
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of Microbiome to Crohn's Disease via Relative Abundance Found in Microbiome Sequencing | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Validation of Sequencing Methods | 1 year | To validate the methods used to sequence samples |
Countries
United States
Outcome results
None listed