Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02868450 |
| Other study ID # |
2013-10 |
| Secondary ID |
2013-A00460-45 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 7, 2013 |
| Est. completion date |
October 26, 2022 |
Study information
| Verified date |
April 2023 |
| Source |
Assistance Publique Hopitaux De Marseille |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In 2012, a previous work showed that T. whipplei is a common bacterium detected in various
situations. A large part of the population is therefore exposed to a T. whipplei but there is
that some people probably with immunological and genetic factors predisposing which develop a
disease. The association teams with experience in HLA-typing will allow us to better identify
patients with a risk of chronic complication.
The main aim of this study is to evaluate if the HLA-DRB13 and/or HLA-DQB106 typing in
patients are risk factors of chronic infection with T. whipplei (defined by classic Whipple
disease and/ or, endocarditis and/or encephalitis).
Description:
Since the first isolation of a strain of Tropheryma whipplei (T. whipplei) and the
development of molecular tools, the natural history of this bacterium continued to clarify.
The currently proposed scheme is as follows: after contamination human oral-oral or fecal,
patients will develop acute infections such as bacteremia, gastroenteritis and pneumonia.
They can then produce specific antibodies. Likely depending on the host-related factors,
three types of evolution appear to be possible: (i) some patients eliminate the bacteria and
develop specific antibodies. (ii) some patients are chronic carriers of the bacterium with a
strong immune response. (iii) Finally, patients develop subacute or chronic infections, with
an insufficient immune response or non-existent answer to T. whipplei.
Subacute or chronic infections include Whipple's disease characterized by histological
involvement of the small intestine, as well as localized without digestive impairment, such
as endocarditis or encephalitis. Despite appropriate antibiotic therapy, patients with
Whipple's disease will present relapse (30-40% of patients), but also of re-infection with
different genotypes of T. whipplei.
Here the hypothesis is that HLA-DRB 13 and/or HLA-DQB1 06 alleles are associated with the
presence of chronic infections with T. whipplei (defined by classic Whipple disease and / or
endocarditis and/or encephalitis)
