We aim to investigate whether a relation between intestinal microbiota composition, mucosal integrity and translocation of bacteria into adipose tissue of the affected eye is related to the severity of Graves orbitopathy.
ID
Source
Brief title
Condition
- Thyroid gland disorders
- Ocular neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine differences in orbital tissue bacterial content and inflammatory
genes expression is associated with clinical disease severity score (CAS) in
Graves orbitopathy patients
Secondary outcome
Differences in gutmicrobiota composition, mucosal integrity, subsequent
endotoxemia and plasma levels of inflammation between subjects with low and
high CAS scores in patients with Graves orbitopathy
Background summary
Graves hyperthyreoidism (prevalencee 400 per 100,000, more females than males,
age of onset between 20*50 years) is an autoimmune disease with undefined
pathophysiology in which thyroid autoantibodies are produced against thyroid
TSH-receptor thus inducing hyperthyroidism. In 10-15% of these cases Graves
Orbitopathy develops due to influx of mononucleair cell (lymfocytic)
infiltration in adipose tissue of the affected eye. recent articles have
suggested a role for the intestinal microbiota composition in the development
of Graves orbitopathy.
Study objective
We aim to investigate whether a relation between intestinal microbiota
composition, mucosal integrity and translocation of bacteria into adipose
tissue of the affected eye is related to the severity of Graves orbitopathy.
Study design
observational study
Study burden and risks
Based on the observational nature of this researchproposal we postulate that
the studyburden is low and risk for participating patients will be nil.
Meibergdreef 9 kamer F4-159.2
Amsterdam 1105 AZ
NL
Meibergdreef 9 kamer F4-159.2
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Caucasian subjects with Graves orbitopathy (males/postmenopauzal females, aged 18 to 69 years-old; and not on concomitant medication besides block/replacement therapy (thyrax en strumazol/PTU))
Exclusion criteria
Use of prednisone/antibiotic in the last three months including proton pump inhibitors (PPI) is prohibited.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL44564.018.13 |