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

NCT04214548 — Withdrawn, ProgenaBiome

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

RegistryNCT04214548
StatusWithdrawn - Company shifted focus
Study typeObservational
SponsorProgenaBiome (Other)
ConditionsEczema
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

Related Papers Related Patents Related Grants Related Experts
All trials for Eczema All trials of No Intervention

-Summary

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

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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 the information provided in surveys and in medical records regarding eczema.

+Arms and interventions

ArmTypeInterventionsDescription
EczemaOther: No InterventionPatients diagnosed with eczema
  • No Intervention (Other): There is no intervention for this study

+Outcome measures

Primary outcomes

  • Correlation of Microbiome to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) via Relative Abundance Found in Microbiome Sequencing [3 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 correlated to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Secondary outcomes

  • Validation of Sequencing Methods [3 years]: To validate the methods used to sequence samples

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Signed informed consent by patient
2. Male or female patients age 18 and older.
3. Diagnosis of eczema

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 stud

+Locations (1)

FacilityCityCountryStatus
ProgenaBiomeVentura, CaliforniaUnited States

+Investigators