Tool for Fibromyalgia Diagnosis and Effect of Extra Virgin Olive Oil

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.

Conditions

• Fibromyalgia

Interventions

DIETARY_SUPPLEMENT

Extra Virgin Olive oil-supplemented Mediterranean Diet Intervention

This intervention (treatment) consist of taking Extra Virgin Olive Oil ("treatment" group made up of 103 patients and 22 healthy people) for 6 months, accompanied by Mediterranean diet-based menus. During this time, blood and stool samples were taken at different points: before the start of the intervention (T0), 3 months after the start (T1), at the end of the intervention in the sixth month (T2) and 6 months after leaving the study (TF). Hence, a total of 4 time points were taken for analysis: T0, T1, T2, TF. Additionally, and following these same time points, the physical and psychological health status of the participants will be evaluated using the SF-36 health questionnaire. Similarly, the course of the pathology in terms of the Fibromyalgia Impact Questionnaire (FIQ) score were recorded.

DIETARY_SUPPLEMENT

Olive oil-supplemented Mediterranean Diet Intervention

This intervention (treatment) consist of taking Olive Oil ("placebo" group made up of 103 patients and 22 healthy people) for 6 months, accompanied by Mediterranean diet-based menus. During this time, blood and stool samples were taken at different points: before the start of the intervention (T0), 3 months after the start (T1), at the end of the intervention in the sixth month (T2) and 6 months after leaving the study (TF). Hence, a total of 4 time points were taken for analysis: T0, T1, T2, TF. Additionally, and following these same time points, the physical and psychological health status of the participants will be evaluated using the SF-36 health questionnaire. Similarly, the course of the pathology in terms of the Fibromyalgia Impact Questionnaire (FIQ) score were recorded.

Sponsors & Collaborators

• Centre for the Development of Industrial Technology, Spain

  collaborator UNKNOWN

• Pronacera Therapeutics SL

  lead INDUSTRY

Principal Investigators

• José Antonio Sánchez Alcázar, MD · Pablo de Olavide University, Seville (Spain)

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

59 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-01-01

Primary Completion

2023-08-31

Completion

2023-12-31

Countries

• Spain

Study Locations