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Efficacy of Fecal Microbial Transplantation Treatment in Adults With Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04283968
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
Weizmann Institute of Science
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Biological: Fecal Microbial Transplantation Biological: placebo fecal transplantation Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Clinical Efficacy of Fecal Microbial Transplantation Treatment in Adults With Moderate-to-Severe Atopic Dermatitis
Actual Study Start Date : June 8, 2020
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment arm
All patients will receive 4 fecal microbial transplantations from healthy donors each 2 weeks apart
Biological: Fecal Microbial Transplantation
Fecal Microbial Transplantation in adults with Atopic Dermatitis

Placebo Comparator: Placebo followed by treatment arm
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
Fecal Microbial Transplantation in adults with Atopic Dermatitis

Biological: placebo fecal transplantation
placebo fecal transplantation




Primary Outcome Measures :
  1. Assessment of the change in the severity of Atopic Dermatitis after treatment with Fecal Microbial Transplantation [ Time Frame: 2 weeks after each FMT, and 8 weeks or more after the last FMT ]
    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.


Secondary Outcome Measures :
  1. Association between the improvement in disease severity and the degree of bacterial strain transmission from donor to patient. [ Time Frame: 2 weeks after each FMT, and 8 weeks or more after the last FMT ]
    Assessment of the relation between the microbiome of donors and patients by calculating DNA sequence dissimilarity between bacterial strains of the same species across donor stool samples that were used for FMT capsules and stool samples that were collected from the patients during the study period.


Other Outcome Measures:
  1. Assessment of the change in the IgE level after treatment with Fecal microbial transplantation [ Time Frame: 2 weeks after each FMT, and 8 weeks or more after the last FMT ]
    Assessment of the change in the IgE level after treatment with Fecal microbial transplantation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  1. Age under 18 years
  2. Pregnancy
  3. Another concomitant active dermatologic disease.
  4. Receiving systemic therapy including phototherapy within 4 weeks before the beginning of the study.
  5. receiving any antibiotic or probiotic treatment within 2 weeks before the beginning of the study or during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283968


Contacts
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Contact: Jacob Mashiah, MD 972527360096 ymashiah1@gmail.com
Contact: Nitsan Maharshak, MD 972527360384 nitsanm@tlvmc.gov.il

Locations
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Israel
Department of Dermatology, Tel Aviv Sourasky medical center Recruiting
Tel Aviv, Israel, 64239
Contact: Jacob Mashiah, MD    972-527360096    ymashiah1@gmail.com   
Principal Investigator: Jacob Mashiah, MD         
Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel
Contact: Nitsan Maharshak, PhD    972-3-6947305    nitsanm@tlvmc.gov.il   
Principal Investigator: Nitsan Maharshak, MD         
Sub-Investigator: Naomi Fliss Isakov, PhD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Weizmann Institute of Science
Investigators
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Principal Investigator: Jacob Mashiah, MD Tel-Aviv Sourasky Medical Center
Study Director: Nitsan Maharshak Tel-Aviv Sourasky Medical Center
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Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT04283968    
Other Study ID Numbers: TLV 0452-17
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After termination of the study protocol for all participants the data and stool and blood samples will be shared in order to perform fecal microbial analysis to examine whether the clinical effect may be mediated by colonization of new bacterial strains
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases