An interventional study of Bifidobacterium adolescentis PRL2019 and Placebo in Fibromyalgia and Fibromyalgia Syndrome, sponsored by Istituto Giannina Gaslini. Recruiting at 1 site in Italy. Open to participants aged 9 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Istituto Giannina Gaslini · Not applicable, Interventional, and Treatment
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Among 41 studies in Fibromyalgia with a site in Italy — 16 open to participants now, 17 under way, none of them phase 3. Fibromyalgia · Italy.
Among the 41 studies in Fibromyalgia with a site in Italy, this one is the 23rd largest by planned enrollment of the 31 interventional ones that give a count, is one of 6 that started in 2026, is one of 21 with no phase, reaches primary completion later than 12 of the 16 other live ones, and was the 38th registered.
1,244 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
Browse Fibromyalgia studies →16 of the 41 studies in Fibromyalgia with a site in Italy are open now. Recruiting first, the newest first:
Italian Association for the Research and the Scientific Update · Sites in Italy
Ages 35–64 · Women only
IRCCS San Raffaele Roma · Sites in Italy
Ages 18–70
University of Roma La Sapienza · Sites in Italy
Ages 18–70 · Women only
Universita degli Studi di Genova · Sites in Italy
Ages 18–65 · Women only
University of Bari · Sites in Italy
Ages 18+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 161 Fibromyalgia studies recruiting now, 50 (31%) set no upper age limit and 97 (60%) stop at 75 or younger; 15 take children under 18; 35 take healthy volunteers.
This study: 9 Years to 25 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
41 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 6 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 60 across 938 interventional studies indexed under Fibromyalgia.
Median enrollment 80 across the 31 interventional studies, 69 across the 10 observational. Of the 23 that completed or were terminated, 5 (22%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 41 have an industry lead sponsor. The 10 most frequent:
Istituto Giannina Gaslini is the lead sponsor of 54 studies on the registry; 36 are open to participants now.
Istituto Giannina Gaslini has 3 studies filed under Fibromyalgia — fewer than ten, so there is no comparison to draw.
8 of the studies in Fibromyalgia with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06135753University of FlorencePsychosomatic Intervention in Fibromyalgia. | 2026-12-30 |
| NCT07641374Italian Association for the Research and the Scientific UpdateAuricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia | 2026-12-31 |
| NCT07865403IRCCS San Raffaele RomaPsychologically Informed Telerehabilitation for Fibromyalgia | 2026-12-31 |
| NCT07785362Istituto Giannina GasliniNeuro-modulation of Central Pain Pathways in Non Inflammatory Musculoskeletal Pain Syndrome | 2027-03 |
| NCT07682090University of Roma La SapienzaTranscutaneous Vagus Nerve Stimulation for Pain and Autonomic Dysfunction in Fibromyalgia (RESET-FMS) | 2027-05-25 |
Add all 8 to your calendar (.ics) → With an account.
Among the 41 studies in Fibromyalgia with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Juvenile Fibromyalgia Syndrome (JFS) is a complex condition characterised by widespread pain, fatigue, and functional impairment. The pathophysiology of JFS is multifactorial, involving mechanisms related to central sensitisation, pain regulation, immune response, and possible alterations in the gut-brain axis.
The intestinal microbiota is involved in several physiological processes, including regulation of immune function, maintenance of intestinal barrier integrity, and production of bioactive metabolites that may influence communication between the gut and nervous system. Alterations in gut microbiota composition have been described in patients with fibromyalgia, and gastrointestinal symptoms are frequently observed in this population.
Gabapral® contains Bifidobacterium adolescentis PRL2019, a probiotic strain naturally found in the human intestinal microbiota. Bifidobacterium adolescentis has been associated with immunomodulatory properties and the production of gamma-aminobutyric acid (GABA), a metabolite involved in gut-brain communication. Preclinical studies have identified PRL2019 among strains with high GABA-producing capacity.
Previous studies have evaluated the safety and potential effects of Bifidobacterium adolescentis PRL2019 in paediatric patients with gastrointestinal disorders, including irritable bowel syndrome. However, its potential role in Juvenile Fibromyalgia Syndrome has not yet been explored.
This study is designed to investigate whether modulation of the gut microbiota through Gabapral® supplementation may influence clinical symptoms and biological pathways associated with JFS. Exploratory microbiota and metabolomic analyses will provide additional information regarding possible mechanisms underlying treatment response.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Bifidobacterium adolescentis PRL2019 · Dietary Supplement: Placebo
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.
Dietary Supplement: Bifidobacterium adolescentis PRL2019 · Dietary Supplement: Placebo
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.
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.
To evaluate the clinical effectiveness of Gabapral® in reducing musculoskeletal pain in paediatric patients with JFS.
Reduction in musculoskeletal pain intensity, measured by the 21-numbered circle Visual Analogue Scale (VAS)14, where 0 corresponds to "no pain" and 10 to "worst imaginable pain". Baseline is defined as the mean VAS scores recorded over the 7 days preceding the start of each treatment period (i.e. before Period 1 start and before crossover to Period 2). The treatment effect is calculated as the change from baseline to the mean VAS score recorded over the last 7 days of the treatment period. A patient will be defined as a responder if achieving a 3 2 points reduction in the weekly average VAS score from baseline. The VAS will be self-reported by all enrolled patients.
Time frame: From the start of each treatment period (baseline) to the end of the 12-week treatment period
To assess changes in abdominal pain intensity following treatment with Gabapral®
Abdominal pain intensity will be assessed using the 21-numbered circle Visual Analogue Scale (VAS) (0-10, with half-point scores permitted), where higher scores indicate greater symptom severity.
Time frame: Change from baseline to the end of each 12-week treatment period
To assess changes in fatigue intensity following treatment with Gabapral®
To asses change in fatigue intensity from baseline following treatment with Gabapral. Fatigue intensity will be assessed using the 21-numbered circle Visual Analogue Scale (VAS) (0-10, with half-point scores permitted), where higher scores indicate greater symptom severity.
Time frame: Change from baseline to the end of each 12-week treatment period
To assess changes in functional measures following treatment with Gabapral®
These Functional outcomes include functional disability assessed using the Functional Disability Inventory (FDI). The FDI comprises 15 items, each rated on a 5-point Likert scale (0 = no trouble, 4 = impossible), yielding a total score ranging from 0 to 60, with higher scores indicating greater functional disability
Time frame: Change from baseline to the end of each 12-week treatment period
To assess changes in headache intensity following treatment with Gabapral®
Change in headache intensity from baseline following treatment with Gabapral. Headache intensity will be assessed using the 21-numbered circle Visual Analogue Scale (VAS) (0-10, with half-point scores permitted), where higher scores indicate greater symptom severity.
Time frame: From the start of each treatment period (baseline) to the end of the 12-week treatment period
To assess changes in global assessment of disease severity following treatment with Gabapral®
Change in global assessment of disease severity from baseline following treatment with Gabapral. Global disease severity will be assessed using the 21-numbered circle Visual Analogue Scale (VAS) (0-10, with half-point scores permitted), where higher scores indicate greater symptom severity.
Time frame: From the start of each treatment period (baseline) to the end of the 12-week treatment period
To assess changes in widespread pain following treatment with Gabapral®
Change in widespread pain from baseline following treatment with Gabapral. Widespread pain will be assessed using the Widespread Pain Index (WPI) (0-19), where higher scores indicate greater widespread pain.
Time frame: From the start of each treatment period (baseline) to the end of the 12-week treatment period
To assess changes in symptom severity following treatment with Gabapral®
Change in symptom severity from baseline following treatment with Gabapral. Symptom severity will be assessed using the Symptom Severity Score (SSS) (0-12), where higher scores indicate greater symptom severity.
Time frame: From the start of each treatment period (baseline) to the end of the 12-week treatment period
To assess changes in depressive symptoms following treatment with Gabapral®.
Change in depressive symptoms from baseline following treatment with Gabapral. Depressive symptoms will be assessed using validated instruments, including the Children's Depression Inventory - Second Edition (CDI-2) (0-56) or the Beck Depression Inventory - Second Edition (BDI-II) (0-63). Higher scores indicate greater depressive symptom severity. Scoring will follow the standardized procedures defined in the respective manuals.
Time frame: Change from baseline to the end of each 12-week treatment period
To assess changes in anxiety symptoms following treatment with Gabapral®
Change in anxiety symptoms from baseline following treatment with Gabapral. Anxiety symptoms will be assessed using validated instruments, including the Multidimensional Anxiety Scale for Children - Second Edition (MASC-2) (0-150) or the State-Trait Anxiety Inventory for Youth (STAI-Y) (20-80 for each subscale). Higher scores indicate greater anxiety symptom severity. Scoring will follow the standardized procedures defined in the respective manuals.
Time frame: Change from baseline to the end of each 12-week treatment period
To characterise the composition of the gut microbiota in a cohort of JFS patients.
Gut microbiota composition will be characterised from fecal samples collected before and after each treatment period using shotgun metagenomic sequencing. Results will be reported as the relative abundance of bacterial taxa at the phylum, genus, and species levels together with alpha- and beta-diversity metrics, summarized descriptively at each study time point.
Time frame: Baseline before Period 1 (Week 0), end of Treatment Period 1 (Week 12), baseline before Period 2 following washout (Week 18), and end of Treatment Period 2 (Week 30).
To examine the impact of Gabapral on gut microbiota composition and related metabolomic pathways.
Changes from baseline in gut microbiota taxonomic composition and diversity, determined by shotgun metagenomic sequencing of fecal samples, and in fecal and plasma metabolomic profiles, determined by untargeted metabolomic analysis, will be evaluated after each treatment period. Metabolomic results will be summarised as differential metabolite abundances (up- and down-regulated metabolites) together with pathway enrichment analyses to identify biological pathways associated with treatment response.
Time frame: Baseline (Week 0) and end of each 12-week treatment period (Week 12 and Week 30).
Plan to share: No
Started Nov 2026 (actual). Primary completion is estimated for Jun 2027, 7 months after the start.
Of 438 non-industry interventional studies with no phase under Fibromyalgia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 7 months is below that.
Counting every sponsor, half of 451 studies reached it within 15 months; a quarter within 6 and three quarters within 30.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 13, 2026: start Aug 2026 → Nov 2026, primary completion Sep 2026 → Jun 2027 and completion Sep 2026 → Jun 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Istituto Giannina Gaslini