Detection and Characteristic of Whipple Diseases in the Great Britany

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03350685

Acronym

WHO

Enrollment

267

Registered

2017-11-22

Start date

2017-11-15

Completion date

2018-02-09

Last updated

2018-02-13

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

Conditions

Whipple Disease

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult * patient with at least a screening test for Whipple'disease * participation agreement,

Exclusion criteria

* No test for Whipple'disease

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

France

Outcome results