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

September 2, 2021 updated by: ProgenaBiome

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Ventura, California, United States, 93003
        • Recruiting
        • ProgenaBiome

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who have been diagnosed with Crohn's disease

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of Sequencing Methods
Time Frame: 1 year
To validate the methods used to sequence samples
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ProgenaBiome

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2020

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

September 20, 2019

First Submitted That Met QC Criteria

September 20, 2019

First Posted (Actual)

September 23, 2019

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 2, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRG-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Only aggregated and deidentified data will be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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