Detection and Characteristic of Whipple Diseases in the Great Britany

Study Overview
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Brief Summary
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Whipple's disease is a chronic systemic infection caused by ubiquitous bacterium Tropheryma wipplei on a genetic predisposition which should be considered in patients with recurrent episodes of seronegative arthritis, erosive or not, or inflammatory low back pain, chronic diarrhea, persistent fever, unexplained neurological signs, uveitis, endocarditis, and epithelioid granuloma. Laboratory tests may show malabsorption, erythrocyte sedimentation rate and C-reactive protein elevation, anemia, thrombocytosis, eosinophilia and lymphopenia. None of theses findings is specific and most patients have arthritis or low back pain mimicking rheumatoid arthritis and spondyloarthritis. As the disease is rare, chance for positive polymerase chain reaction testing for Tropheryma whipplei is low in this context.

Official Title
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Detection and Characteristic of Whipple Diseases in the Great Britany

Conditions
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Whipple Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient with at least a screening test for Whipple'disease participation agreement, Exclusion Criteria: No test for Whipple'disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Classic Whipple's disease (CWD)<br>Classic Whipple's disease (CWD), defined as duodenal biopsy positive by PAS/immunohistochemistry or blood positive by PCR | |
| Focal Whipple's disease (FWD)<br>Focal Whipple's disease (FWD), defined as joint fluid positive by PCR but duodenal biopsy negative by PAS/immunohistochemistry | |
| Chronic T. whipplei-associated arthritis (CTWA)<br>Chronic T. whipplei-associated arthritis (CTWA) defined as chronic arthritis and duodenal biopsy, stool, or saliva positive by PCR duodenal biopsy negative by PAS/immunohistochemistry joint fluid negative by PCR | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients diagnosed as whipple's disease | Diagnosis of Whipple's disease based on at least one suggestive clinical finding at least one test detecting T. Whipplei diagnosis made by a specialist a dramatic and persistent response to antibiotic therapy Hydroxychloroquine 200mgx2 plus Doxycycline 100mgx2 or trimethoprim/sulfamethoxazole 800/160mg x2 | Day 0 ( Date of diagnostic) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of test performed in each centre | Number of diagnoses according to tests Patients will be divided into three groups Classic Whipple's disease (CWD), defined as : duodenal biopsy positive by PAS/immunohistochemistry or blood positive by PCR Focal Whipple's disease (FWD) joint fluid positive by PCR but duodenal biopsy negative by PAS/immunohistochemistry Chronic T. whipplei-associated arthritis (CTWA): chronic arthritis and duodenal biopsy, stool, or saliva positive by PCR duodenal biopsy negative by PAS/immunohistochemistry joint fluid negative by PCR | Day 0 (Date of diagnostic) |