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PRL2019 in the Treatment of Juvenile Fibromyalgia

Key facts

Who runs it
Istituto Giannina Gaslini
Where
Italy1 site in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
People taking part
30 people, planned
Started
1 Aug 2026
Planned end
30 Sept 2026
Type of study
Interventional, 2 groups
Treatments tested
  • Bifidobacterium adolescentis PRL2019
  • Placebo
Record updated
31 July 2026

Who can take part

Age
9 years to 25 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • presence of concomitant organic GI diseases, such as inflammatory bowel disease, celiac disease, eosinophilic or autoimmune gastroenteropathies, or history of major abdominal surgery
  • antibiotic treatment within 3 months prior to recruitment
  • use of any prebiotic, probiotic, or postbiotic in the previous 2 months before enrolment
  • any conditions that may affect the ability to complete informed consent
  • acute infection at the time of recruitment
  • significant eating disorders, including diagnosed eating behaviour disorders
  • denial of the informed consent

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 9 and 25 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

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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.

The 2 groups in the trial

  • Gabapral® followed by PlaceboTreatment being tested

    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.

    Treatment: Bifidobacterium adolescentis PRL2019 and Placebo

  • Placebo followed by Gabapral®Treatment being tested

    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.

    Treatment: Bifidobacterium adolescentis PRL2019 and Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Prospective, Randomised, Controlled Crossover Study on the Effectiveness of Bifidobacterium Adolescentis PRL2019 in the Treatment of Juvenile Fibromyalgia
Fit questions
Built from NCT07738926, who can take part
Record updated
31 July 2026