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NOT YET RECRUITING
NCT07738926
NA

PRL2019 in the Treatment of Juvenile Fibromyalgia

Sponsor: Istituto Giannina Gaslini

View on ClinicalTrials.gov

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

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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