Tool for Fibromyalgia Diagnosis and Effect of Extra Virgin Olive Oil — FIBROKIT  

Fibromyalgia Clinical Trial

Official title: Development of a New Tool for the Diagnosis and Monitoring of Fibromyalgia "FIBROKIT"

Status Active, not recruiting

Clinical Trial Summary

PRONACERA THERAPEUTICS S.L. is a young biotechnological company focused on the development of genetic diagnostic tools and treatments for pathologies in different medical areas such as reproduction, fibromyalgia and rare diseases or with deficiencies in diagnosis, with the aim of helping to optimize health systems through improvement in terms and forms of diagnosis. Among the multiple lines of R+D+i that are currently being developed, the reproductive genomic line and endometrial functional molecular biology stand out. Specifically, it develops the design of markers and performs the genetic analysis of infertility focused on female endometrial tissue.

Fibromyalgia is a complex and common chronic pain disorder that affects 12 million Europeans. Along with other symptoms, fibromyalgia causes pain and general tenderness to touch. Currently this disease is diagnosed following the criteria established by the American College of Rheumatology (ACR) of a combination of relevant symptoms and the description of how the person feels. In other words, in practice it is a diagnosis by elimination. A patient suffering from fibromyalgia usually takes between 2 to 3 years to obtain the correct diagnosis. Health experts consider that fibromyalgia is a disease that is difficult to diagnose and that is associated with an expensive use of health system services.

With FIBROKIT, Pronacera aims to design and develop a new diagnostic and monitoring tool for fibromyalgia by designing a panel of specific plasma proteome and intestinal microbiome biomarkers and reducing the number of biological samples used. During the execution of this project, the company will have three leading research and innovation organizations in the sector (Helix BioS, CINUSA and CICbioGUNE) that will support Pronacera. FIBROKIT will have a cohort of 250 participants (206 patients and 44 healthy volunteers) to validate the diagnostic capacity of the tool and perform a robust biostatistical study.

Clinical Trial Description

Fibromyalgia (FM) is a chronic syndrome characterized mainly by the presence of widespread pain. This pain is usually accompanied by other alterations, both physically and psychologically, which, ultimately, seriously compromise people's quality of life, affecting their family, social and work environment and causing high social-sanitary costs. Although different factors such as an imbalance at the oxidative level or control of the inflammatory response have been studied, to date it is not known exactly what molecular alteration is responsible for the appearance and development of FM. This situation makes extremely difficult the search for a curative treatment and a specific and accurate laboratory diagnosis. The concept of FIBROKIT was born with the intention of solving both shortcomings. Thus, the main objective of this project is to fully design the panel of specific biomarkers to use in FIBROKIT. To achieve this great objective, three specific objectives have been set:

1. Design, based on new scientific evidence, the components of the molecular diagnostic panel focused on Peripheral Blood Mononuclear Cell-specific proteins, plasma proteome and intestinal microbiome biomarkers.

2. Increase the number of patients participating in the study to validate the diagnostic capacity of the kit with robust statistics.

3. Analytically validate the response of the new panel of molecular markers to the course of the pathology and its monitoring under a nutritional intervention with olive oil-supplemented mediterranean diet. ;

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

• NCT number: NCT05921409
• Study type: Interventional
• Source: Pronacera Therapeutics SL
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2021
• Completion date: December 31, 2023