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

NCT04100005 | Withdrawn DMC

• 1 other identifier: PRG-008
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

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; Crohn's

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Validation of Sequencing Methods

  1 year

Study Arms (1)

Crohn's disease

Patients who have been diagnosed with Crohn's disease

Other: No intervention

Interventions

No intervention OTHER

There is no intervention for this study.

Crohn's disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who have been diagnosed with Crohn's disease

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ProgenaBiome: lead

Study Sites (1)

ProgenaBiome

Ventura, California, 93003, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Sabine Hazan, MD

  ProgenaBiome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 23, 2019
• Study Start: March 2, 2020
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

US (1)