Efficacy of Fecal Microbial Transplantation Treatment in Adults With Atopic Dermatitis

Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2020
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 first group all patients will receive 4 fecal microbial transplantations (FMTs) from healthy donors each 2 weeks apart. In the second group all patients will receive 4 placebo transplantations each 2 weeks apart. Patients will be allowed to continue with their baseline medical topical treatment, including moisturizers and glucocorticoids, during the study period, but no new therapy should be commenced. The patients of the second group, who received the placebo treatment will have the possibility to enter an open label phase in which they will receive 4 fecal microbial transplantations (FMTs) from healthy donors each 2 weeks apart. The severity of AD and the fecal microbiome profile will be evaluated by the Scoring Atopic Dermatitis Score (SCORAD score), Investigator Global Assessment scale for Atopic Dermatitis (IGA) and the weekly use of topical corticosteroids, at the beginning of the study, before every FMT, and 1-6 months after the last FMT.
Epistemonikos ID: 02fd2903d5419701f4eaf3d5d0bcb77f88ceb6b0
First added on: Nov 24, 2021