Efficacy of Fecal Microbial Transplantation Treatment in Adults With Atopic Dermatitis

NCT04613037 | Completed Early Phase 1

• 1 other identifier: 0452-17
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Assessment of the change in the severity of Atopic Dermatitis after treatment with Fecal Microbial Transplantation

  Overall mean change from baseline of the Scoring atopic dermatitis score (SCORAD), described and validated by the European Task Force on Atopic Dermatitis, used for the assessment of the severity of Atopic Dermatitis. The minimal SCORAD score, describing a situation without any signs of atopic dermatitis is 0, the disease is not visible, while the maximal score, describing the most severe presentation of atopic dermatitis, is 103.

  2 weeks after each FMT, and 8 weeks or more after the last FMT

Secondary Outcomes (2)

• Assessment of the degree of bacterial strain transmission from donor to patient after treatment with Fecal Microbial Transplantation

  2 weeks after each FMT, and 8 weeks or more after the last FMT

• Assessment of the correlation between bacterial stains transmission from donor to patient to the SCORAD score change after treatment with Fecal Microbial Transplantation

  2 weeks after each FMT, and 8 weeks or more after the last FMT

Study Arms (1)

Treatment arm

EXPERIMENTAL

Fecal Microbial Transplantation in adults with Atopic Dermatitis

Biological: Fecal Microbial Transplantation

Interventions

Fecal Microbial Transplantation BIOLOGICAL

Fecal Microbial Transplantation in adults with Atopic Dermatitis

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are ≥18 years of age
• Moderate-to-severe atopic dermatitis, as defined by a Scoring Atopic Dermatitis Score (SCORAD) score ≥25
• Disease duration minimum of 3 years that was inadequately controlled by topical and systemic therapy

You may not qualify if:

• 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 4 weeks before the beginning of the study or during the study

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• Weizmann Institute of Science: collaborator

Study Sites (1)

Department of Dermatology, Tel Aviv Sourasky medical center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jacob Mashiah, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

• Nitsan Maharshak, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: November 3, 2020
• Study Start: November 1, 2017
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: November 3, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After termination of the study protocol for all participants the data and stool and blood samples were shared
• Access Criteria: All information was given to the researcher that performed the fecal microbial analysis

Locations

IL (1)