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

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ClinicalTrials.gov Identifier: NCT04100005
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : September 5, 2021
Information provided by (Responsible Party):

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
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Crohn's Disease
Actual Study Start Date : March 2, 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Group/Cohort Intervention/treatment
Crohn's disease
Patients who have been diagnosed with Crohn's disease
Other: No intervention
There is no intervention for this study.

Primary Outcome Measures :
  1. Correlation of Microbiome to Crohn's Disease via Relative Abundance Found in Microbiome Sequencing [ Time Frame: 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 [ Time Frame: 1 year ]
    To validate the methods used to sequence samples

Biospecimen Retention:   Samples With DNA
Stool samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients who have been diagnosed with Crohn's disease

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04100005

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Contact: Sabine Hazan, MD 8053390549 drsabinehazan@progenabiome.com
Contact: Jordan Daniels, MS 18053390549 jordan@progenabiome.com

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United States, California
ProgenaBiome Recruiting
Ventura, California, United States, 93003
Contact: Sabine Hazan, MD    805-339-0549    drsabinehazan@progenabiome.com   
Contact: Jordan Daniels, MS    805-339-0549    jordan@progenabiome.com   
Principal Investigator: Sabine Hazan, MD         
Sponsors and Collaborators
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Principal Investigator: Sabine Hazan, MD ProgenaBiome
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Responsible Party: ProgenaBiome
ClinicalTrials.gov Identifier: NCT04100005    
Other Study ID Numbers: PRG-008
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Only aggregated and deidentified data will be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Esophageal Diseases
Stomach Diseases
Duodenal Diseases
Ileal Diseases