Detection and Characteristic of Whipple Diseases in the Great Britany

NCT ID: NCT03350685

Last Updated: 2018-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

267 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-15

Study Completion Date

2018-02-09

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.

Detailed Description

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Conditions

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Whipple Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Classic Whipple's disease (CWD)

Classic Whipple's disease (CWD), defined as

* duodenal biopsy positive by PAS/immunohistochemistry
* or blood positive by PCR

No interventions assigned to this group

Focal Whipple's disease (FWD)

Focal Whipple's disease (FWD), defined as

* joint fluid positive by PCR
* but duodenal biopsy negative by PAS/immunohistochemistry

No interventions assigned to this group

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

No interventions assigned to this group

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU d'ANGERS

Angers, , France

Site Status

CHRU de Brest

Brest, , France

Site Status

CH le MAns

Le Mans, , France

Site Status

CHU de Nantes

Nantes, , France

Site Status

CH d'ORLEANS

Orléans, , France

Site Status

CHU de POITIERS

Poitiers, , France

Site Status

CHU de Rennes

Rennes, , France

Site Status

CHU de Tours

Tours, , France

Site Status

Countries

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France

Other Identifiers

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WHO (29BRC17.0179)

Identifier Type: -

Identifier Source: org_study_id

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