Could a probiotic soothe fibromyalgia pain in young people?
NCT ID NCT07738926
First seen Jul 31, 2026 · Last updated Jul 31, 2026
Summary
This study tests whether a daily probiotic supplement, Bifidobacterium adolescentis PRL2019, can reduce pain in young people aged 9 to 25 with juvenile fibromyalgia, a condition marked by widespread musculoskeletal pain. Participants will take the probiotic or a placebo for 12 weeks, then switch, allowing each person to serve as their own comparison. The trial measures changes in pain scores and other symptoms to see if gut bacteria modulation might offer relief.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Bifidobacterium adolescentis PRL2019 (probiotic supplement)
- What this could lead to
- If effective, this probiotic could offer a simple, well-tolerated option to reduce pain and improve quality of life for young people with fibromyalgia.
- What could go wrong
- This is a small early-stage trial, and the supplement may not outperform placebo. Effects on pain could be modest, and individual responses may vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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9 to 25 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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IRCCS Giannina Gaslini
Genova, Genova, 16147, Italy
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