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OpenTrials
Completed

NCT Number: NCT03350685

Detection and Characteristic of Whipple Diseases in the Great Britany

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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Key information

Conditions

Whipple Disease Actinomycetales Infections Actinomycosis Bacterial Infections Bacterial Infections and Mycoses Digestive System Diseases Gastrointestinal Diseases Gram-Positive Bacterial Infections Infections Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d'ANGERS, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No test for Whipple'disease

Treatment and study plan

Primary outcomes

  1. Number of patients diagnosed as whipple's disease

    Time frame: 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

  1. Number of test performed in each centre

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: WHO

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 22, 2017
Registry last updated
Feb 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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