Status:
UNKNOWN
Efficacy of Fecal Microbial Transplantation Treatment in Adults With Atopic Dermatitis
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Collaborating Sponsors:
Weizmann Institute of Science
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Prospective double-blinded placebo-controlled study, among adult patients suffering from moderate-to-severe atopic dermatitis (AD), insufficiently responsive to topical and systemic treatment. In the ...
Detailed Description
This is a prospective, double-blinded, placebo-controlled study aimed to assess the safety and clinical efficacy of FMT for the treatment of mild-moderate AD, and to assess the change in the fecal mic...
Eligibility Criteria
Inclusion
- Patients who are ≥18 years of age, with moderate-to-severe atopic dermatitis, as defined by a Scoring Atopic Dermatitis Score (SCORAD) score ≥25, with disease duration minimum of 3 years that was inadequately controlled by topical and systemic therapy
Exclusion
- Age under 18 years
- Pregnancy
- Another concomitant active dermatologic disease.
- Receiving systemic therapy including phototherapy within 4 weeks before the beginning of the study.
- receiving any antibiotic or probiotic treatment within 2 weeks before the beginning of the study or during the study
Key Trial Info
Start Date :
October 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04283968
Start Date
October 15 2020
End Date
June 1 2024
Last Update
July 22 2022
Active Locations (2)
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1
Department of Dermatology, Tel Aviv Sourasky medical center
Tel Aviv, Israel, 64239
2
Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel