Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Completed NCT04624581

FIbromyalgia anD GenetIcs Subgroups (FIDGIS)

Conditions: Fibromyalgia

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 260
Sponsor: University Hospital, Clermont-Ferrand

Location: CHU de Clermont-Ferrand Clermont-Ferrand

Summary

Fibromyalgia syndrome (FS) is characterized by widespread pain and affect 0.5 to 5 % of the general population, with a higher prevalence in women. Recognized as disease by World Health Organization since 1992, FS concern 1.2 to 2 million of French people and his etiology need to be clarified. This affection is characterized by a higher sensitivity to nociceptive stimulus, articular and muscular pain and associated to: fatigue, headache, sleep disorders, depression and irritated bowel syndrome. The presentation of this symptoms varied according to the patient with a heterogeneity of the clinical, physical, social and psychologic conditions and of the therapeutic responses. Faced to the heterogeneity of FS, various hypotheses about the development mechanisms exist. Central sensitization could be one of the key mechanisms of FS, it is described as a loss of the natural balance between the transmission of a painful stimulus to the central nervous system and pain-inhibiting mechanisms, which results in permanent or chronic pain. Moreover, work on the familial character of FS suggests that a genetic component may be involved in its development, but the identification of a genetic determinant is difficult given the multifactorial nature and complexity of FS. The objective of this study is to characterize the predispositions of central sensitization and genetics in patients with FS compared to a control group, matched in age, sex and menopausal status.

Eligibility Criteria

Patient Inclusion criteria : * Patient between 18 and 65 years old (included), * Patient with fibromyalgia according to the criteria of the 2016 ACR, * Patient weighing more than 45kg * Cooperation and understanding sufficient to comply with the requirements of the study, * Acceptance to give written consent, * Affiliation to the French Social Security system, Patient exclusion criteria : * treated with antibiotics in the three months prior to inclusion, * who has reported gastroenteritis in the two months prior to inclusion, * having a medical and / or surgical history judged by the investigator or his representative to be incompatible with the test * of childbearing age not using an effective contraceptive method, pregnant or breastfeeding woman. * participating in another clinical trial, or being in the exclusion period, or having received a total amount of benefits exceeding EUR 4500 over the 12 months preceding the start of the trial, * benefiting from a measure of legal protection (guardianship, guardianship, deprivation of liberty, safeguard of justice), Subject inclusion criteria: * Aged of more than 18 years, * weighing more than 45kg * non-painful subjects matched by age (+/- 5 years), by sex, and by menopausal status for women, * Cooperation and understanding sufficient to comply with the requirements of the study, * Acceptance of written consent, * Affiliation to the French Social Security system, * Registration or acceptance of registration in the National Register of Volunteers participating in research. Subject exclusion criteria : * treated with antibiotics in the three months prior to inclusion, * who has reported gastroenteritis in the two months prior to inclusion, * Medical and / or surgical history judged by the investigator or his representative to be incompatible with the test, * Intake of any drugs in the 7 days before inclusion, * Pregnant or nursing woman * Participating in another clinical trial, or within the exclusion period, or having received a total amount of compensation in excess of EUR 4500 over the 12 months preceding the start of the trial, * Benefiting from a measure of legal protection (curatorship, guardianship, safeguard of justice ...)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04624581). StuddyBuddy aggregates publicly available trial information.