Efficacy of Fecal Microbial Transplantation Treatment in Adults With Atopic Dermatitis

NCT04283968 | Unknown Phase 3

• 1 other identifier: TLV 0452-17
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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 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.

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 (1)

• Association between the improvement in disease severity and the degree of bacterial strain transmission from donor to patient.

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

Other Outcomes (1)

• Assessment of the change in the IgE level after treatment with Fecal microbial transplantation

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

Study Arms (2)

Treatment arm

EXPERIMENTAL

All patients will receive 4 fecal microbial transplantations from healthy donors each 2 weeks apart

Biological: Fecal Microbial Transplantation

Placebo followed by treatment arm

PLACEBO COMPARATOR

All patients will receive 4 placebo fecal transplantations followed by 4 fecal microbial transplantations from healthy donors each 2 weeks apart

Biological: Fecal Microbial Transplantation; Biological: placebo fecal transplantation

Interventions

Fecal Microbial Transplantation BIOLOGICAL

Fecal Microbial Transplantation in adults with Atopic Dermatitis

Placebo followed by treatment arm; Treatment arm

placebo fecal transplantation BIOLOGICAL

placebo fecal transplantation

Placebo followed by treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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 2 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 (2)

Department of Dermatology, Tel Aviv Sourasky medical center

Tel Aviv, 64239, Israel

RECRUITING

Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

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

  Tel-Aviv Sourasky Medical Center

  STUDY DIRECTOR

Central Study Contacts

Jacob Mashiah, MD

CONTACT

972527360096; ymashiah1@gmail.com

Nitsan Maharshak, MD

CONTACT

972527360384; nitsanm@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The care providers, investigators, outcome assessor, and the participants do not know which of the transplantations is placebo and which is fecal microbial one during the first phase of the study. After the 4 transplantations the patients of the placebo group will have the possibility to enter an open label study in which they will receive 4 fecal transplantations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 25, 2020
• Study Start: October 15, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2024
• Last Updated: July 22, 2022

Record last verified: 2022-07

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 will be shared
• Access Criteria: All information will be given to the researcher that will perform the fecal microbial analysis

Locations

IL (2)