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Role of the Microbiome in Graves' Orbitopathy

NCT02373995 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-02-27

No results posted yet for this study

Summary

Graves' orbitopathy (GO), also known as thyroid eye disease, affects approximately 3 million people in Europe with an estimated socioeconomic burden of 6.4 billion euros per annum. GO is a complication of Graves' disease which is an autoimmune disease and the commonest cause of an overactive thyroid gland. The treatment of GO remains unsatisfactory and the majority of patients report long-term impairment of quality of life. The effects of gut derived antigens, from micro-organisms and nutrients, on the autoimmune response will be tested in the animal model by probiotic and "contra-biotic" intervention. In the Indigo interventional trial the investigators will add to the standard anti-thyroid drug treatment (ATD) a specifically designed probiotics (LAB4, Cultech Ltd., West Glamorgan, UK) to assess whether it is possible to modify the microbiome in GD patients and improve their immunological status.

Conditions

  • Graves' Disease

Interventions

BIOLOGICAL

LAB4

Additional treatment with the specific LAB4 probiotic preparation

Sponsors & Collaborators

  • Cultech Ltd, Port Talbot, UK

    collaborator UNKNOWN

  • Universität Duisburg-Essen

    collaborator OTHER

  • School of Medicine and School of Biosciences, Cardiff University, Cardiff, UK

    collaborator UNKNOWN

  • IDRA Laboratory, Parco Tecnologico Padano s.r.l, Lodi, Italy

    collaborator UNKNOWN

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Principal Investigators

  • Mario Salvi, MD · IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico Milano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-07-31
Completion
2016-12-31

Countries

  • Italy

Study Locations

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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 NCT02373995 on ClinicalTrials.gov