PRL2019 in the Treatment of Juvenile Fibromyalgia (NCT07738926) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
PRL2019 in the Treatment of Juvenile Fibromyalgia
Italy30 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
9 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the clinical effectiveness of Gabapral® in reducing musculoskeletal pain in paediatric patients with JFS.
Timeframe: From the start of each treatment period (baseline) to the end of the 12-week treatment period