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

NCT04214483 — Withdrawn, ProgenaBiome

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

RegistryNCT04214483
StatusWithdrawn - Company shifted focus
Study typeObservational
SponsorProgenaBiome (Other)
ConditionsAcne, Acne Vulgaris, Acne Keloidalis, Acne Keloid, Acne Conglobata, Acne Rosacea, Acne Inversa, Acne Cystic, Acne Pomade, Acne Indurata, Acne Papular, Acne Tropica, Acne Urticata, Acne Fulminans, Acne Follicular, Acne Tropicalis, Acne Detergicans, Acne Iodide, Acne Varioliformis
InterventionsNo intervention (Other)
Datesstart 2020-03-02, primary completion 2030-03-01 (estimated), completion 2030-07-01 (estimated), first posted 2020-01-02, last updated 2025-06-05
Locations1 site in United States

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-Summary

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

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+Detailed description

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to acne.

+Arms and interventions

ArmTypeInterventionsDescription
Diagnosis of AcneOther: No interventionPatients who have been diagnosed with acne, subdivided into the various types.
  • No intervention (Other): There is no intervention for this study.

+Outcome measures

Primary outcomes

  • Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing [Three years]: 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 categorized with acne.

+Eligibility

Sex: All

Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study

   a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
2. Male or female of all ages.
3. Diagnosis of acne by a physician

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition

+Locations (1)

FacilityCityCountryStatus
ProgenaBiomeVentura, CaliforniaUnited States

+Investigators

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