Whipple DiseaseWHONCT03350685
Detection and Characteristic of Whipple Diseases in the Great Britany
An observational study of Whipple Disease, run by University Hospital, Brest at 8 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Whipple Disease
- How many people
- 267 participants
- Where
- 8 sitesFrance
- Study dates
- 15 Nov 2017to 9 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis whipple's disease
Who may be able to join
- Adult
- patient with at least a screening test for Whipple'disease
- participation agreement,
Who cannot join
- No test for Whipple'disease
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CHU d'ANGERS
Angers, 49933
CHRU de Brest
Brest, 29609
CH le MAns
Le Mans, 72037
CHU de Nantes
Nantes, 44093
CH d'ORLEANS
Orléans, 450000
CHU de POITIERS
Poitiers, 86 021
CHU de Rennes
Rennes, 35000
CHU de Tours
Tours, 37044
About this study
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.
Read more
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.
- Conditions
- Whipple Disease
- Medical subject headings
- Whipple Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Number of patients diagnosed as whipple's disease
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
Measured: Day 0 ( Date of diagnostic)
Secondary outcomes (1)
Number of test performed in each centre
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
Measured: Day 0 (Date of diagnostic)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start15 Nov 2017
- Primary completion9 Feb 2018
- Study completion9 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whipple DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350685
- Sponsor's protocol ID
- WHO (29BRC17.0179)
- Acronym
- WHO
- Status last verified
- Feb 2018
- First submitted
- 17 Nov 2017
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Characteristic of Whipple Diseases in the Great Britany
- ClinicalTrials.gov ID
- NCT03350685
- Acronym / sponsor ID
- WHO / WHO (29BRC17.0179)
- Conditions
- Whipple Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 9 Feb 2018 (actual)
- Study completion
- 9 Feb 2018 (actual)
- First posted
- 22 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis whipple's disease
Key inclusion criteria (3 listed)
- Adult
- patient with at least a screening test for Whipple'disease
- participation agreement,
Key exclusion criteria (1 listed)
- No test for Whipple'disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Number of test performed in each centre
Time frame: Day 0 (Date of diagnostic)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Whipple Disease, run by University Hospital, Brest at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients diagnosed as whipple's disease (time frame: Day 0 ( Date of diagnostic)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.