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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04099979
Enrollment
0
Registered
2019-09-23
Start date
2020-03-02
Completion date
2030-07-31
Last updated
2025-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis, Psoriasis Annularis, Psoriasis Circinata, Psoriasis Diffusa, Psoriasis Face, Psoriasis Genital, Psoriasis Geographica, Psoriasis Nail, Psoriasis of Scalp, Psoriasis Palmaris, Psoriasis Punctata, Psoriasis Universalis, Psoriasis Vulgaris, Psoriatic Plaque

Brief summary

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

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

Interventions

OTHERNo Intervention

There is no intervention for this study

Sponsors

ProgenaBiome
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation of Microbiome to Psoriasis via Relative Abundance Found in Microbiome Sequencing1 yearRelative 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

MeasureTime frameDescription
Validation of Sequencing Methods1 yearTo validate the methods used to sequence samples

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026