NCT05418686

Study of Colchicine Resistance in Familial Mediterranean Fever

Study Of Colchicine Resistance In Familial Mediterranean Fever

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Five to 10% of familial mediterranean patients are considered colchicine-resistant (i.e. patients with a persistent inflammatory syndrome, despite taking the maximum tolerated dose of colchicine daily). The recommended treatment in this case is a subcutaneous anti-interleukin 1 biotherapy (anakinra or canakinumab). These treatments are expensive (1,000 to 12,000 euros/month). However, for a patient to be considered colchicine-resistant, compliance with the treatment must be verified. Furthermore specific activation of the pyrin inflammasome by Clostrioides difficile toxin and the overrepresentation of these bacteria in the stools of our patients led us to systematically search for them in our resistant patients. The demonstration of the involvement of C. difficile in the imbalance of the disease has not yet been published. The colchiresist study aim to better characterize colchicine-resistance by confirming good compliance to treatment with colchicine hair measurement and by looking for clostrioides infection or intestinal dysbiosis.

Detailed description

Patients meeting the criteria for colchicine resistance will be included in a follow-up visit. * Adherence to colchicine therapy will be assessed by the Girerd questionnaire completed by the patient at the inclusion visit. * A blood test is performed including a haemogram, CRP and SAA, creatinine and proteinuria. * a standard stool analysis on site to look for C. difficile toxin. For research purposes, samples of: * Stool. * A strand of hair with the diameter of a pencil and a minimum length of 2 cm, in the region of the posterior vertex, where the growth and integration are relatively constant to avoid variability. * In patients with baldness or bleached hair only: pubic and/or axillary hair will be taken, The samples will then be processed without segmentation. * Additional blood (5ml) and urine (2ml) samples for colchicine dosage. The patient's participation ends after this visit

Conditions

• Mediterranean Fever
• Colchicine Resistance

Interventions

Type	Name	Description
BIOLOGICAL	Capillary colchicine dosage in colchicine-resistant Familial Mediterranean Fever patients.	* Adherence to colchicine therapy will be assessed by the Girerd questionnaire (6 questions ) completed by the patient at the inclusion visit. * A blood sample (8ml) is taken, including a haemogram, CRP and creatinine and proteinuria. * Standard on-site stool analysis for C. difficile toxin. For research purposes, samples of: * Stool. If the patient is unable to produce stools on the day of the visit, a collection kit with 2 tubes containing a preservative will be given to him/her as well as a stamped envelope to take the sample at home and send it by post within 10 days according to a validated procedure. * A strand of hair with the diameter of a pencil and a minimum length of 2 cm, in the region of the posterior vertex. * In patients with baldness or bleached hair only: pubic and/or axillary hair, a pencil-sized strand. * Additional blood (5ml) and urine (2ml) samples for colchicine determination.

Timeline

• Start date: 2022-12-09
• Primary completion: 2023-07-04
• Completion: 2023-10-27
• First posted: 2022-06-14
• Last updated: 2024-04-08

Locations

1 site across 1 country: France