Detection and Characteristic of Whipple Diseases in the Great Britany

NCT03350685 — Completed, 267 participants, University Hospital, Brest

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Registry	NCT03350685, acronym WHO
Status	Completed
Study type	Observational
Enrollment	267 (Actual)
Sponsor	University Hospital, Brest (Other)
Conditions	Whipple Disease
Dates	start 2017-11-15, primary completion 2018-02-09, completion 2018-02-09, first posted 2017-11-22, last updated 2018-02-13
Locations	8 sites in France

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
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

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

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

Exclusion Criteria:

* No test for Whipple'disease

+Locations (8)

Facility	City	Country
CHU d'ANGERS	Angers	France
CHRU de Brest	Brest	France
CH le MAns	Le Mans	France
CHU de Nantes	Nantes	France
CH d'ORLEANS	Orléans	France
CHU de POITIERS	Poitiers	France
CHU de Rennes	Rennes	France
CHU de Tours	Tours	France