Epidermolysis Bullosa Clinical Trial
Official title:
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Epidermolysis Bullosa
NCT number | NCT04213703 |
Other study ID # | PRG-034 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 2, 2020 |
Est. completion date | July 2023 |
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | July 2023 |
Est. primary completion date | March 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study i. 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. (interest is given to children who present with autism or Crohn's and whose parents wish to analyze their children's gut flora. Also of interest analysis of development of the child's microbiome. In the case of autism, the younger the child, the better to correct the neurological problems if an association is found between autism and the microbiome) 3. Diagnosis of Epidermolysis by at least one of the following i. Biopsy ii. Genetic testing 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 |
Country | Name | City | State |
---|---|---|---|
United States | ProgenaBiome | Ventura | California |
Lead Sponsor | Collaborator |
---|---|
ProgenaBiome |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation of Microbiome to Disease 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 categorized with Epidermolysis Bullosa | Three years |
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