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PRL2019 in the Treatment of Juvenile Fibromyalgia
Sponsor: Istituto Giannina Gaslini
Summary
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.
Official title: A Prospective, Randomised, Controlled Crossover Study on the Effectiveness of Bifidobacterium Adolescentis PRL2019 in the Treatment of Juvenile Fibromyalgia
Key Details
Gender
All
Age Range
9 Years - 25 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-08-01
Completion Date
2026-09-30
Last Updated
2026-07-31
Healthy Volunteers
No
Conditions
Interventions
Bifidobacterium adolescentis PRL2019
Gabapral® 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
Matching 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.
Locations (1)
IRCCS Giannina Gaslini
Genova, Genova, Italy