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Trial record 9 of 11 for:    progenabiome

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Clostridoides Difficile Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04100603
Recruitment Status : Not yet recruiting
First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Information provided by (Responsible Party):

Brief Summary:
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Condition or disease Intervention/treatment
Clostridium Difficile Clostridium Difficile Infection Microbiome CDI 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 infection with C. diff.

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Study Type : Observational
Estimated 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 Clostridoides Difficile Infection
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : July 10, 2020
Estimated Study Completion Date : December 31, 2020

Group/Cohort Intervention/treatment
Patients with CDI
Patients who are infected with C. diff
Other: No Intervention
There is no intervention for this study

Primary Outcome Measures :
  1. Correlation of Microbiome to 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 with C. diff infection

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
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with C. difficile infection

Inclusion Criteria:

  • Willingness to sign informed consent
  • Diagnosis of C. difficile infection
  • Age of 18 and older

Exclusion Criteria:

  • Refusal by patient to sign informed consent form
  • Treatment with antibiotics 2 weeks prior to screening
  • Treatment with probiotics 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 of patient 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 identifier (NCT number): NCT04100603

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Contact: Jordan Daniels 805-339-0549

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United States, California
ProgenaBiome Not yet recruiting
Ventura, California, United States, 93003
Contact: Sabine Hazan, MD    805-339-0549   
Contact: Jordan Daniels, MS    805-339-0549   
Principal Investigator: Sabine Hazan, MD         
Sponsors and Collaborators

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Responsible Party: ProgenaBiome Identifier: NCT04100603     History of Changes
Other Study ID Numbers: ProgenaBiome-004
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only aggregated deidentified data will be made available to 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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Communicable Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections