PRL2019 in the Treatment of Juvenile Fibromyalgia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-25
SponsorIstituto Giannina Gaslini
About this trial
Juvenile Fibromyalgia Syndrome (JFS) is a chronic condition affecting children and adolescents, characterised by widespread musculoskeletal pain and a significant impact on daily life and quality of life. Gastrointestinal symptoms and changes in gut microbiota have been reported in patients with fibromyalgia, suggesting a possible role of the gut-immune system interaction in the disease.
This study aims to investigate whether Gabapral®, a food supplement containing the probiotic strain Bifidobacterium adolescentis PRL2019, may help reduce pain symptoms and improve clinical outcomes in paediatric patients with JFS.
The hypothesis of this study is that modulation of the gut microbiota with Gabapral® may contribute to improvement of symptoms related to Juvenile Fibromyalgia Syndrome.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged between 9 and 25 years;
Written informed consent to participate in the study obtained prior to the start of the study from the patient or both parents/legal guardians of the patient if a minor, and the assent of the minor;
Diagnosis of JFS according to the 2010 American College of Rheumatology (ACR) criteria 15, with disease onset before 18 years of age;
Willingness to comply with follow-up visits and provide biological samples (blood and stool) according to the schedule defined in the protocol.
Disqualifiers
any conditions that may affect the ability to complete informed consent;
denial of the informed consent;
presence of concomitant organic GI diseases, such as inflammatory bowel disease, celiac disease, eosinophilic or autoimmune gastroenteropathies, or history of major abdominal surgery;
acute infection at the time of recruitment;
Trial design
Design model
Crossover
Treatments tested in this trial
Bifidobacterium adolescentis PRL2019
Dietary supplementGabapral® is an oral food supplement containing Bifidobacterium adolescentis PRL2019, provided as single-dose oral sticks containing 20 × 10\^9 colony-forming units (CFU). Participants will receive one oral stick once daily for a 12-week treatment period according to the assigned treatment sequence. The product is gluten- and lactose-free.
Placebo
Dietary supplementMatching placebo provided as an oral supplement stick, identical to Gabapral® in appearance, taste, texture, weight, and packaging. The placebo does not contain Bifidobacterium adolescentis PRL2019 or other active microorganisms. Participants will receive one oral stick once daily during the assigned 12-week treatment period.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Gabapral® followed by PlaceboExperimental treatment 2 interventions
Group B: Placebo followed by Gabapral®Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
To evaluate the clinical effectiveness of Gabapral® in reducing musculoskeletal pain in paediatric patients with JFS.
Reduction in musculoskeletal pain intensity, measured by the 21-numbered circle Visual Analogue Scale (VAS)14, where 0 corresponds to "no pain" and 10 to "worst imaginable pain". Baseline is defined as the mean VAS scores recorded over the 7 days preceding the start of each treatment period (i.e. before Period 1 start and before crossover to Period 2). The treatment effect is calculated as the change from baseline to the mean VAS score recorded over the last 7 days of the treatment period. A patient will be defined as a responder if achieving a 3 2 points reduction in the weekly average VAS score from baseline. The VAS will be self-reported by all enrolled patients.
Time frame
From the start of each treatment period (baseline) to the end of the 12-week treatment periodSecondary outcomes
1
To assess changes in abdominal pain intensity following treatment with Gabapral®
Abdominal pain intensity will be assessed using the 21-numbered circle Visual Analogue Scale (VAS) (0-10, with half-point scores permitted), where higher scores indicate greater symptom severity.
Time frame
Change from baseline to the end of each 12-week treatment period2
To assess changes in fatigue intensity following treatment with Gabapral®
To asses change in fatigue intensity from baseline following treatment with Gabapral. Fatigue intensity will be assessed using the 21-numbered circle Visual Analogue Scale (VAS) (0-10, with half-point scores permitted), where higher scores indicate greater symptom severity.
Time frame
Change from baseline to the end of each 12-week treatment period3
To assess changes in functional measures following treatment with Gabapral®
These Functional outcomes include functional disability assessed using the Functional Disability Inventory (FDI). The FDI comprises 15 items, each rated on a 5-point Likert scale (0 = no trouble, 4 = impossible), yielding a total score ranging from 0 to 60, with higher scores indicating greater functional disability
Time frame
Change from baseline to the end of each 12-week treatment period4
To assess changes in headache intensity following treatment with Gabapral®
Change in headache intensity from baseline following treatment with Gabapral. Headache intensity will be assessed using the 21-numbered circle Visual Analogue Scale (VAS) (0-10, with half-point scores permitted), where higher scores indicate greater symptom severity.
Time frame
From the start of each treatment period (baseline) to the end of the 12-week treatment periodSponsors and contacts
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Source ClinicalTrials.gov
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