Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 40 for:    progenabiome
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04214548
Recruitment Status : Recruiting
First Posted : January 2, 2020
Last Update Posted : March 6, 2020
Sponsor:
Information provided by (Responsible Party):
ProgenaBiome

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

Condition or disease Intervention/treatment
Eczema Other: No Intervention

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Eczema
Actual Study Start Date : March 2, 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Group/Cohort Intervention/treatment
Eczema
Patients diagnosed with eczema
Other: No Intervention
There is no intervention for this study




Primary Outcome Measures :
  1. Correlation of Microbiome to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) via Relative Abundance Found in Microbiome Sequencing [ Time Frame: 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 Outcome Measures :
  1. Validation of Sequencing Methods [ Time Frame: 3 years ]
    To validate the methods used to sequence samples


Biospecimen Retention:   Samples With DNA
Stool Samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients with eczema
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04214548


Contacts
Layout table for location contacts
Contact: Sabine Hazan, MD 8053390549 sabinehazan@aim.com
Contact: Jordan Daniels, MS 8053390549 msjordandaniels@gmail.com

Locations
Layout table for location information
United States, California
ProgenaBiome Recruiting
Ventura, California, United States, 93003
Contact: Sabine Hazan, MD    805-339-0549    sabinehazan@aim.com   
Contact: Jordan Daniels, MS    805-339-0549    msjordandaniels@gmail.com   
Principal Investigator: Sabine Hazan, MD         
Sponsors and Collaborators
ProgenaBiome
Investigators
Layout table for investigator information
Principal Investigator: Sabine Hazan, MD ProgenaBiome
Layout table for additonal information
Responsible Party: ProgenaBiome
ClinicalTrials.gov Identifier: NCT04214548    
Other Study ID Numbers: ProgenaBiome-037
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only aggregated and deidentified data will be shared with other investigators

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ProgenaBiome:
microbiome
Additional relevant MeSH terms:
Layout table for MeSH terms
Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous