PRL2019 in the Treatment of Juvenile Fibromyalgia

Sponsor
Istituto Giannina Gaslini
Study ID
NCT07738926
Status
Not Yet Recruiting

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Conditions

  • Fibromyalgia
  • Fibromyalgia Syndrome

Eligibility Criteria

Sex
ALL
Age
9 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Bifidobacterium adolescentis PRL2019 — DIETARY_SUPPLEMENT
    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 — DIETARY_SUPPLEMENT
    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.

Study Details

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.

Key Dates

First listed
Jul 31, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Sep 1, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Gabapral® followed by Placebo
    Participants assigned to this sequence will receive Gabapral® (Bifidobacterium adolescentis PRL2019) as an oral supplement once daily for 12 weeks. This treatment period will be followed by a 6-week washout period without study treatment. Participants will then receive matching placebo once daily for 12 weeks. Treatments will be administered under double-blind conditions.
  • Experimental: Placebo followed by Gabapral®
    Participants assigned to this sequence will receive matching placebo as an oral supplement once daily for 12 weeks, followed by a 6-week washout period without study treatment. Participants will then receive Gabapral® (Bifidobacterium adolescentis PRL2019) once daily for 12 weeks. Treatments will be administered under double-blind conditions.

Primary Outcome Measure

To evaluate the clinical effectiveness of Gabapral® in reducing musculoskeletal pain in paediatric patients with JFS. [ Time Frame: From the start of each treatment period (baseline) to the end of the 12-week treatment period ]

Central Contacts

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