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WithdrawnNCT04099979Updated Jun 5, 2025

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

An observational study in Psoriasis, Psoriasis Vulgaris and Psoriasis Universalis, sponsored by ProgenaBiome. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-05.

Sponsored by ProgenaBiome · Observational

Why this study was withdrawn
Company focus shifted
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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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Conditions studied

  • 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

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In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

Browse Psoriasis studies →

Lead sponsor

ProgenaBiome is the lead sponsor of 47 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients 18 years of age or older who have been diagnoed with Psoriasis

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Psoriasis patients

    Patients who have been diagnosed with Psoriasis

    Other: No Intervention

Interventions

  • OtherNo Intervention

    There is no intervention for this study

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What researchers measure

Primary outcomes

  1. Correlation of Microbiome to Psoriasis via Relative Abundance Found in Microbiome Sequencing

    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

    Time frame: 1 year

Secondary outcomes

  1. Validation of Sequencing Methods

    To validate the methods used to sequence samples

    Time frame: 1 year

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Study locations

1 site
  • ProgenaBiome
    Ventura, California 93003, United States
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References and documents

Individual participant data

Plan to share: Undecided — Only aggregated and deidentified data will be shared with other researchers.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04099979
Lead sponsor
ProgenaBiome
Responsible party
Sponsor
First posted
Sep 23, 2019
Start date
Mar 2, 2020 (estimated)
Primary completion
Mar 2030 (estimated)
Completion
Jul 2030 (estimated)
Last update
Jun 5, 2025

Study contacts

Sabine Hazan, MD
principal investigator · ProgenaBiome

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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