Detection and Characteristic of Whipple Diseases in the Great Britany
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StatusCompleted
Sponsors
University Hospital, Brest
CLINICAL TRIAL: NCT03350685
BioSeek: NCT03350685
Keywords
Abstract
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.
Dates
| Last Verified: | 01/31/2018 |
| First Submitted: | 11/16/2017 |
| Estimated Enrollment Submitted: | 11/20/2017 |
| First Posted: | 11/21/2017 |
| Last Update Submitted: | 02/11/2018 |
| Last Update Posted: | 02/12/2018 |
| Actual Study Start Date: | 11/14/2017 |
| Estimated Primary Completion Date: | 02/08/2018 |
| Estimated Study Completion Date: | 02/08/2018 |
Condition or disease
Whipple Disease
Phase
-
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Classic Whipple's disease (CWD) Classic Whipple's disease (CWD), defined as
duodenal biopsy positive by PAS/immunohistochemistry
or blood positive by PCR | |
| Focal Whipple's disease (FWD) 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) 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 |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Sampling method | Probability Sample |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Adult - patient with at least a screening test for Whipple'disease - participation agreement, Exclusion Criteria: - No test for Whipple'disease |
Outcome
Primary Outcome Measures
1. Number of patients diagnosed as whipple's disease [Day 0 ( Date of diagnostic)]
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
Secondary Outcome Measures
1. Number of test performed in each centre [Day 0 (Date of diagnostic)]
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
