PRL2019 in the Treatment of Juvenile Fibromyalgia
Not yet recruitingNot applicableNCT07738926
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Prospective, Randomised, Controlled Crossover Study on the Effectiveness of Bifidobacterium Adolescentis PRL2019 in the Treatment of Juvenile Fibromyalgia
- Conditions
- Interventions
- Dietary supplement: Bifidobacterium adolescentis PRL2019
- Dietary supplement: Placebo
- Sponsor
- Istituto Giannina Gaslini
- Start date
- 2026-08-01
- Primary completion
- 2026-09-01
- Sex
- All
- Age range
- from 9 Years to 25 Years
- Results posted
- No results posted in this snapshot
- Countries
- Italy
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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. Exclusion Criteria: * 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; * antibiotic treatment within 3 months prior to recruitment; * use of any prebiotic, probiotic, or postbiotic in the previous 2 months before enrolment; * significant eating disorders, including diagnosed eating behaviour disorders.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07738926