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

• Sponsor: ProgenaBiome (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04100005
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 40
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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; Crohn's	Other: No intervention

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.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Crohn's Disease
• Actual Study Start Date: Mar 2, 2020
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Crohn's disease Patients who have been diagnosed with Crohn's disease	Other: No intervention; There is no intervention for this study.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Validation of Sequencing Methods [1 year]

   To validate the methods used to sequence samples

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

4. Colonoscopy

5. Capsule Endoscopy

6. Computerized Tomography (CT) Scan

7. Magnetic Resonance Imaging (MRI)

8. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ProgenaBiome	Ventura	California	United States	93003

Sponsors and Collaborators

• ProgenaBiome

Investigators

• Principal Investigator: Sabine Hazan, MD, ProgenaBiome

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ProgenaBiome
• ClinicalTrials.gov Identifier: NCT04100005
• Other Study ID Numbers: PRG-008
• First Posted: Sep 23, 2019
• Last Update Posted: Sep 5, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Crohn Disease; Esophagitis; Gastritis; Duodenitis; Ileitis

Study Results

No Results Posted as of Sep 5, 2021