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Efficacy of Fecal Microbial Transplantation Treatment in Adults With Atopic Dermatitis

NCT04613037 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-11-03

No results posted yet for this study

Summary

Prospective single-blinded placebo-controlled cross-over study, among adult patients suffering from moderate-to-severe atopic dermatitis (AD), insufficiently responsive to topical and systemic treatment. All patients receive 2 placebo transplantations each 2 weeks apart followed by 4 fecal microbial transplantations (FMTs) from healthy donors each 2 weeks apart. Patients were allowed to continue with their baseline medical topical treatment, including moisturizers and glucocorticoids, during the study period, but no new therapy was commenced. The severity of AD and the fecal microbiome profile was evaluated by the Scoring Atopic Dermatitis Score (SCORAD score), and the weekly use of topical corticosteroids, at the beginning of the study, before every FMT, and 1-6 months after the last FMT.

Conditions

Interventions

BIOLOGICAL

Fecal Microbial Transplantation

Fecal Microbial Transplantation in adults with Atopic Dermatitis

Sponsors & Collaborators

  • Weizmann Institute of Science

    collaborator OTHER

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • Jacob Mashiah, MD · Tel-Aviv Sourasky Medical Center

  • Nitsan Maharshak, MD · Tel-Aviv Sourasky Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2019-07-30
Completion
2019-07-30

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04613037 on ClinicalTrials.gov