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WithdrawnNCT04213703Updated Jun 5, 2025

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

An observational study in Epidermolysis Bullosa, Epidermolysis Bullosa Simplex and Epidermolysis Bullosa Dystrophica, sponsored by ProgenaBiome. Withdrawn at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-06-05.

Sponsored by ProgenaBiome · Observational

Why this study was withdrawn
Company shifted focus
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
0
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Epidermolysis Bullosa
  • Epidermolysis Bullosa Simplex
  • Epidermolysis Bullosa Dystrophica
03

In context

Epidermolysis Bullosa

126 studies on the registry are indexed under Epidermolysis Bullosa; 23 are open to participants now.

Browse Epidermolysis Bullosa studies →

Lead sponsor

ProgenaBiome is the lead sponsor of 47 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who have been diagnosed with Epidermolysis Bullosa

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patients with Epidermolysis Bullosa

    Patients who have been diagnosed with Epidermolysis Bullosa

    Other: No intervention

Interventions

  • OtherNo intervention

    There is no intervention for this study

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Three years

07

Study locations

1 site
  • ProgenaBiome
    Ventura, California 93003, United States
08

References and documents

Individual participant data

Plan to share: No — There is no plan to share IPD

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04213703
Lead sponsor
ProgenaBiome
Responsible party
Sponsor
First posted
Dec 30, 2019
Start date
Mar 2, 2020
Primary completion
Mar 2030 (estimated)
Completion
Jul 2030 (estimated)
Last update
Jun 5, 2025

Study contacts

Sabine Hazan, MD
principal investigator · ProgenaBiome

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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