We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Pilot Study to Explore the Role of Gut Flora in Psoriasis

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.
 
ClinicalTrials.gov Identifier: NCT04099979
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
ProgenaBiome

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Psoriasis.

Condition or disease Intervention/treatment
Psoriasis Psoriasis Vulgaris Psoriasis Universalis Psoriasis Face Psoriasis Nail Psoriatic Plaque Psoriasis Diffusa Psoriasis Punctata Psoriasis Palmaris Psoriasis Circinata Psoriasis Annularis Psoriasis Genital Psoriasis of Scalp Psoriasis Geographica 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 Psoriasis
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Psoriasis
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: Psoriasis

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Psoriasis patients
Patients who have been diagnosed with Psoriasis
 Other: No Intervention
There is no intervention for this study


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Correlation of Microbiome to Psoriasis 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 correlated with specific Psoriasis 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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Patients 18 years of age or older who have been diagnoed with Psoriasis
Criteria

Inclusion Criteria:

  1. Signed informed consent by patient
  2. Male or female patients age 18 and older.
  3. Diagnosis of Psoriasis based on PSAI of greater than or equal to 12 at screening

Exclusion Criteria:

  1. Refusal by patient to sign informed consent form
  2. Treatment with antibiotics within 2 weeks prior to screening
  3. Treatment with probiotics within 6 weeks prior to screening
  4. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
  5. Postoperative stoma, ostomy, or ileoanal pouch
  6. Participation in any experimental drug protocol within the past 12 weeks
  7. Treatment with total parenteral nutrition
  8. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
  9. Inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04099979


Contacts
Layout table for location contacts
Contact: Sabine Hazan, MD 18053390549 drsabinehazan@progenabiome.com
Contact: Jordan Daniels, MS 18053390549 jordan@progenabiome.com

Locations
Layout table for location information
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
ProgenaBiome
Investigators
Layout table for investigator information
Principal Investigator: Sabine Hazan, MD ProgenaBiome
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: ProgenaBiome
ClinicalTrials.gov Identifier: NCT04099979    
Other Study ID Numbers: PRG-011
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases