NCT05921409: FIBROKIT

Tool for Fibromyalgia Diagnosis and Effect of Extra Virgin Olive Oil

Status unknown NA Last updated 14 July 2023

What this trial tests

NA trial testing Extra Virgin Olive oil-supplemented Mediterranean Diet Intervention in Fibromyalgia in 250 participants. Status unknown.

Timeline

1 January 2021

Primary endpoint
31 August 2023

31 December 2023

Quick facts

Lead sponsor	Pronacera Therapeutics SL
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	diagnostic
Enrollment	250
Start date	1 January 2021
Primary completion	31 August 2023
Estimated completion	31 December 2023
Sites	1 location across Spain

Drugs / interventions tested

• Extra Virgin Olive oil-supplemented Mediterranean Diet Intervention
• Olive oil-supplemented Mediterranean Diet Intervention

Conditions studied

• Fibromyalgia — all drugs for Fibromyalgia →

Sponsor

Pronacera Therapeutics SL

Who can join

Adults 40 to 59, female only, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Study protocol for FIBROKIT: a new tool for fibromyalgia diagnosis and patient follow-up.
   Del Amo LL, Durán-González E, Ramírez-Tejero JA, Martínez-Lara A, et al · · 2023 · cited 2× · PMID 38073622 · DOI 10.3389/fneur.2023.1286539
2. Fibromyalgia diagnosis from a multi-omics approach: a gut feeling.
   Durán-González E, Ramírez-Tejero JA, Pérez-Sánchez M, Morales-Torres C, et al · · 2025 · PMID 41113645 · DOI 10.3389/fmicb.2025.1641185