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

ProgenaBiome

Status: Withdrawn

Conditions: Crohn's Esophagitis; Crohn's Disease of Pylorus; Crohn Disease of Ileum; Crohn's Ileocolitis; Crohn's Disease Relapse; Crohn's Gastritis; Crohn Disease in Remission; Crohn's Jejunitis; Crohn's Duodenitis; Crohn Colitis; Crohns Disease Aggravated; Crohn's; Crohn Ileitis; Crohn Disease

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT04100005

PRG-008

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Crohn's disease

Description:

Patients who have been diagnosed with Crohn's disease

Treatment:

Other: No intervention