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Chronic Infection With Tropheryma Whipplei: Risk Factors Related to the Host

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02868450
Acronym
WHIPPLE
Enrollment
246
Registered
2016-08-16
Start date
2013-06-07
Completion date
2022-10-26
Last updated
2023-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Whipple Infection

Brief 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).

Detailed 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)

Interventions

BIOLOGICALBlood Sample

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient with a positive PCR to T. Whipplei diagnostics. * Patient aged \> or = 18 years old. * Patient who does not declined to have his medical records reviewed for research. * Patient with health insurance.

Exclusion criteria

* Patient minors (age \<18 years) * Pregnant woman, parturient or breastfeeding * Adult Patient under guardianship . * Patient deprived of liberty under court order * Patient refusing to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with HLA-DQB1 06 among patients with a chronic infection with T. whipplei (defined by classic Whipple disease and / or endocarditis and/or encephalitis) versus asymptomatic patients1 day
Proportion of patients with HLA-DRB 13 among patients with a chronic infection with T. whipplei (defined by classic Whipple disease and / or endocarditis and/or encephalitis) versus asymptomatic patients1 day

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026