Development of a New Tool for the Diagnosis and Monitoring of Fibromyalgia "FIBROKIT"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 250
- Locations
- 2
- Primary Endpoint
- Microtubule-associated proteins 1B light chain 3B (LC3B)
Study Overview
Brief 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.
Detailed 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:
- 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.
- Increase the number of patients participating in the study to validate the diagnostic capacity of the kit with robust statistics.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Treatment (extra virgin olive oil) and placebo (olive oil) were packed in 50 ml opaque envelopes for patients masking. Letters A and B were assigned randomly to each treatment by an external person not participating in the study design or analysis for investigator masking.
Eligibility Criteria
- Ages
- 40 Years to 59 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Women between 40 and 59 years
- •Do not carry out any type of guided and structured physical activity (detailed in the
Exclusion Criteria
- •Follow a balanced diet in terms of the food source (fruits, vegetables, legumes, meat, fish, etc.).
- •Exclusion Criteria:
- •Being outside the established age range (40-59) at the time of the start of the study
- •Have practiced some type of structured or planned physical activity more than 2 times a week during the last month, such as:
- •Go to collective classes of Yoga, Tai-Chi, Zumba, dance, gymnastics or similar
- •Going for a walk, cycling, hiking or similar for 30 minutes or more than 10,000 steps per day
- •Being underweight (BMI < 18.5) or type II or higher obesity (BMI > 34.9)
- •Suffer and have been diagnosed with any of the following chronic pathologies:
- •any type of cancer
- •Acquired Immunodeficiency Syndrome (AIDS)
- •Inflammatory diseases (rheumatoid arthritis, osteoarthritis)
- •Gastrointestinal diseases (Crohn's disease, ulcerative colitis)
- •Cardiovascular diseases (atherosclerosis, cardiomyopathy, stroke)
- •Autoimmune diseases (systemic lupus erythematosus, celiac disease, Hashimoto's thyroiditis, multiple sclerosis)
- •Metabolic diseases (Type I and II Diabetes, Metabolic Syndrome)
- •Having been under intensive pharmacological treatment (3 or more drugs daily) with non-steroidal anti-inflammatory drugs, corticosteroids, analgesics, or antidepressants during the month prior to the start of the study.
- •Being under antioxidant supplementation (Glutathione, Coenzyme Q10, plant extracts, phenolic compounds)
- •Consuming an amount greater than 12 g/day of alcohol, admitted in the context of the Mediterranean diet (Willett et al., 1995).
- •Smoking or consuming any type of narcotic substance (regardless of the amount and frequency)
Outcomes
Primary Outcomes
Microtubule-associated proteins 1B light chain 3B (LC3B)
Time Frame: 24 weeks
LC3B protein determination by western blot
Concentration of Plasma Proteins
Time Frame: 48 weeks
Plasma proteome Analysis by label-free nano Liquid Chromatography coupled to tandem mass spectrometry after top-14 depletion
Abundance of Bacteria from the Intestinal Microbiome
Time Frame: 48 weeks
Fecal metagenomic analysis by amplicon sequencing of hypervariable region V3-V4 from RNA 16S bacterial gene
Concentration of Microtubule-associated proteins 1B light chain 3B (LC3B)
Time Frame: 48 weeks
LC3B protein determination by western blot
Concentration of Voltage dependent anion channel 1 protein (VDAC)
Time Frame: 48 weeks
VDAC protein determination by western blot
Secondary Outcomes
- 36-Item Short Form Health Survey (SF-36) Score(48 weeks)
- Fibromyalgia Impact Questionnaire (FIQ) Score(48 weeks)