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Trial record 5 of 11 for:    progenabiome

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

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ClinicalTrials.gov Identifier: NCT04099979
Recruitment Status : Not yet recruiting
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
ProgenaBiome

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

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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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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




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


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
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

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
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Contact: Sabine Hazan, MD 8053390549 sabinehazan@aim.com
Contact: Jordan Daniels, MS 8053390549 msjordandaniels@gmail.com

Locations
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United States, California
ProgenaBiome
Ventura, California, United States, 93003
Sponsors and Collaborators
ProgenaBiome
Investigators
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Principal Investigator: Sabine Hazan, MD ProgenaBiome

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Responsible Party: ProgenaBiome
ClinicalTrials.gov Identifier: NCT04099979     History of Changes
Other Study ID Numbers: ProgenaBiome-011
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
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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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases