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NCT04213703 Clinical Trial

A Pilot Study to Explore the Role of Gut Flora in Epidermolysis Bullosa

Epidermolysis Bullosa Clinical Trial

Official title:
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Epidermolysis Bullosa

Clinical Trial Details — Status: Recruiting

Administrative data
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

Study information
Verified date September 2021
Source ProgenaBiome
Contact Sabine Hazan, MD
Phone 18053390549
Email drsabinehazan@progenabiome.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
There is no intervention for this study

Locations
Country Name City State
United States ProgenaBiome Ventura California

Sponsors (1)
Lead Sponsor Collaborator
ProgenaBiome

Country where clinical trial is conducted

United States, 

Outcome
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
See also
  Status Clinical Trial Phase
Completed NCT00380640 - The Efficacy of Trimethoprim in Wound Healing of Patients With Epidermolysis Bullosa Phase 2
Completed NCT00004761 - Establishment of the National Epidermolysis Bullosa Registry N/A
Completed NCT01263379 - Gene Transfer for Recessive Dystrophic Epidermolysis Bullosa Phase 1/Phase 2
Completed NCT01716169 - Treatment of Chronic and Non-Chronic Wounds in Patients With Recessive Dystrophic Epidermolysis Bullosa Using Helicoll Collagen Dressings Versus Standard of Care N/A
Withdrawn NCT01454687 - Grafting of Epidermolysis Bullosa Wounds Using Cultured Revertant Autologous Keratinocytes N/A
Completed NCT00014729 - Phase I Study of Isotretinoin in Patients With Recessive Dystrophic Epidermolysis Bullosa Phase 1
Recruiting NCT05838092 - Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III) Phase 3
Recruiting NCT03269474 - Computational Drug Repurposing for All EBS Cases
Completed NCT03068780 - Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa Phase 3
Terminated NCT02090283 - Open-Label Extension Study to Evaluate the Safety of SD-101 Cream in Participants With Epidermolysis Bullosa Phase 2
Completed NCT02582775 - MT2015-20: Biochemical Correction of Severe EB by Allo HSCT and Serial Donor MSCs Phase 2
Completed NCT02384460 - ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa Phase 3
Terminated NCT02670330 - Open Label Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients With Epidermolysis Bullosa Phase 3
Terminated NCT01619670 - A Observational Study to Evaluate Apligraf(R) in Nonhealing Wounds of Subjects With Epidermolysis Bullosa Phase 4
Recruiting NCT01340235 - Treatment of Dowling Maera Type of Epidermolysis Bullosa Simplex by Oral Erythromycin Phase 3
Completed NCT02014376 - Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa Phase 2
Completed NCT04217538 - Observational Study of a Cohort of Patients With Hereditary Epidermolysis Bullosa
Completed NCT03942250 - Uses of Irradiated Human Amniotic Membrane in the Treatment of Dystrophic Epidermolysis Bullosa Patients N/A
Completed NCT01033552 - Biochemical Correction of Severe EB by Allo HSCT and "Off-the-shelf" MSCs Phase 1/Phase 2
Completed NCT04227106 - Phase 3, Open-label Clinical Trial of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB) Phase 3