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

NCT ID: NCT04099979

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-02

Study Completion Date

2030-07-31

Brief Summary

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This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Psoriasis.

Detailed Description

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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

Conditions

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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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Psoriasis patients

Patients who have been diagnosed with Psoriasis

No Intervention

Intervention Type OTHER

There is no intervention for this study

Interventions

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No Intervention

There is no intervention for this study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ProgenaBiome

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sabine Hazan, MD

Role: PRINCIPAL_INVESTIGATOR

ProgenaBiome

Locations

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ProgenaBiome

Ventura, California, United States

Site Status

Countries

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United States

Other Identifiers

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PRG-011

Identifier Type: -

Identifier Source: org_study_id

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