Biological Evolution of Whipple's Disease (WHIP) (WHIP)

Biological Evolution of Whipple's Disease

Whipple's disease (WD), a rare systemic infection by Tropheryma whipplei, lacks research on biological abnormalities pre- and post-treatment. This study explores these abnormalities for their diagnostic and monitoring value.

Study Overview

• Status: Completed
• Conditions: Whipple Disease

Detailed Description

Whipple's disease (WD) is a rare systemic infection caused by *Tropheryma whipplei*. Despite advancements in diagnosis through PCR and biopsy, there is limited research comparing biological abnormalities before and after treatment. This study aimed to characterize these abnormalities and evaluate their potential for aiding in diagnosis and monitoring.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHU Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Retrospective study of patients hospitalised in Brest who tested positive for Whipple's disease between 2010 and 2024

Description

Inclusion Criteria:

• Patients with at least one positive PCR test for Whipple's disease and a retained diagnosis at Brest University Hospital between 2010 and 2024
• Major patient

Exclusion Criteria:

• Minors
• No screening test for Whipple's disease
• Opposition to participation
• Protected patients

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biological changes	Biological changes (inflammation, liver function tests, haematology, lymphocyte subpopulations) in patients diagnosed with classic, localised or reactive Whipple's disease	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 14, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Intestinal Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Malabsorption Syndromes; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Actinomycosis; Whipple Disease
• Other Study ID Numbers: 29BRC24.0315 - WHIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No