Detection and Characteristic of Whipple Diseases in the Great Britany (WHO)

February 12, 2018 updated by: University Hospital, Brest

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

267

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • CHU d'Angers
      • Brest, France, 29609
        • CHRU de Brest
      • Le Mans, France, 72037
        • CH Le Mans
      • Nantes, France, 44093
        • CHU de Nantes
      • Orleans, France, 450000
        • CH d'Orleans
      • Poitiers, France, 86 021
        • CHU de Poitiers
      • Rennes, France, 35000
        • CHU de Rennes
      • Tours, France, 37044
        • CHU de Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with a diagnosis whipple's disease

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • No test for Whipple'disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0 ( Date of diagnostic)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0 (Date of diagnostic)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2017

Primary Completion (Actual)

February 9, 2018

Study Completion (Actual)

February 9, 2018

Study Registration Dates

First Submitted

November 17, 2017

First Submitted That Met QC Criteria

November 21, 2017

First Posted (Actual)

November 22, 2017

Study Record Updates

Last Update Posted (Actual)

February 13, 2018

Last Update Submitted That Met QC Criteria

February 12, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WHO (29BRC17.0179)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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