Role of the Microbiome in Graves' Orbitopathy (Indigo)
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|ClinicalTrials.gov Identifier: NCT02373995|
Recruitment Status : Unknown
Verified February 2015 by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
Recruitment status was: Not yet recruiting
First Posted : February 27, 2015
Last Update Posted : February 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Graves' Disease||Biological: LAB4||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Investigation of Novel Biomarkers and Definition of the Role of the Microbiome In Graves' Orbitopathy|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||December 2016|
Active Comparator: LAB4
In addition to conventional Anti Thyroid Drug (ATD), LAB4 probiotic preparation will be administered at the 2 cps x 2/die dosing with food for 6 months. It is key to properly store LAB4 at 8°C.
Additional treatment with the specific LAB4 probiotic preparation
Placebo Comparator: Placebo
In addition to conventional Anti Thyroid Drug (ATD) a LAB4 placebo preparation will be administered at the 2 cps x 2/die dosing with food for 6 months. It is key to properly store placebo at 8°C.
- Microbiome modification (beneficial modification of the gut microbioma relates to a reduction at the end of treatment of at least 5% of the Firmicutes:Bacteroides ratio and 30% of the anti-TSHr antibody titer and of total IgG and IgA concentrations) [ Time Frame: 6 months ]modification the microbiome in GD patients to reduce pathogenic species and enrich its commensal, symbiotic components. The proportion (%) of each species will be assessed and recorded.
- Improvement immunological status (antibody responses will be analyzed to identify if microbial or food derived antigens are involved in triggering disease or associated with GO progression) [ Time Frame: 6 months ]To decrease the anti-TSHr antibody titer and the concentration of IgG and IgA in patients with Graves' disease. The concentration of each parameter will be assessed in mg/dl and recorded.
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): NCT02373995
|Contact: Mario Salvi, MDfirstname.lastname@example.org|
|Contact: Giuseppe Colucci, MDemail@example.com|
|Fondazione Ca' Granda Ospedale Maggiore Policlinico|
|Milan, Italy, 20122|
|Principal Investigator:||Mario Salvi, MD||IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico Milano|