ECE2019 Guided Posters Thyroid Autoimmune Disorders (12 abstracts)
The randomised probiotic trial of indigo study (investigation of novel biomarkers and definition of role of the microbiome in Graves’ orbitopathy)
Mario Salvi 1 , Giuseppe Colucci 1 , Giulia Masetti 2 , Danila Covelli 1 , Ilaria Muller 1, , Hedda Koehling 3 , Iveta Garaiova 4 , Daryn Michael 4 , Lei Zhang 2 , Marian Ludgate 2 , Julian Marchesi 2 & Filippo Biscarini 5
1Graves’ Orbitopathy Centre, Fondazione IRCCS Cà Granda and University of Milan, Milan, Italy; 2School of Medicine, Cardiff University, Cardiff, UK; 3Department of Ophthalmology, University Hospital Essen/University of Duisburg-Essen, Essen, Germany; 4Cultech Ltd, Port Talbot, Cardiff, UK; 5CNR, Milan, Italy.
Background: Changes of the gut microbiota may impact on the mechanisms of immune tolerance in Graves’ disease (GD) and Graves’ orbitopathy (GO). Probiotics, which contain live micro-organisms, can modify the composition of the gut microbiota.
Aims: We tested in a double-blind randomized placebo controlled trial whether the administration of a well-characterized, commercially available, probiotic would 1) modify the microbiota composition in GD/GO patients, 2) change the natural course of GD and/or GO progression, and 3) affect the systemic immunological status.
Methods: The probiotic compound LAB4 comprises 25 billion colony-forming-units/capsule of two Lactobacillus acidophilus strains plus Bidifobacterium bifidum and Bidifobacterium animalis var.lactis. Thirty GD patients untreated or within 4 weeks of anti-thyroid therapy (ATD) were randomized to receive LAB4 (n=14, 11 women and 3 men) or placebo (n=16, 14 women and 2 men) for 6 months orally while treated with ATD. Ten patients in each arm had mild to moderate GO. Serum concentrations of IgA, IgG, TSH, FT4, FT3, autoantibodies to the thyrotropin receptor (TRAb) and gene sequencing for 16S rRNA on fecal samples were assessed at baseline, at euthyroidism (EU) and at the end of 6 months follow-up (EFU).
Results: At EU we observed a significant reduction in counts of the Firmicutes phylum in the probiotics group compared to placebo (P=0.033). At EFU, 6 and 5 patients on placebo were hyperthyroid and euthyroid, respectively, compared to 3 and 8 on probiotics (P=NS). At EFU GD patients treated with placebo had higher FT3 concentrations than those receiving probiotics (P<0.05). Severity or progression of GO were not different between patients in the placebo or probiotic group. IgA and IgG levels were transiently lower (at EU) in patients treated with probiotics (P<0.01 and P=0.02, respectively), and returned to baseline levels after probiotic withdrawal. The probiotic administration did not affect TRAb levels.
Conclusions: Although these results have to be confirmed in a larger clinical trial, we suggest that probiotics are effective in modifying the microbiota composition in GD patients. GD patients on probiotics seem to relapse less at 6 months after ATD therapy, compared with those on placebo. Probiotics induce a transient, but significant decrease of both circulating IgA and IgG, suggesting a systemic effect of the treatment.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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