FibromyalgiaIGG-microbiotaNCT07738926
PRL2019 in the Treatment of Juvenile Fibromyalgia
A study testing Bifidobacterium adolescentis PRL2019 in people with Fibromyalgia and Fibromyalgia Syndrome, run by Istituto Giannina Gaslini at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 25 years
- Conditions the study is for
- Fibromyalgia, Fibromyalgia Syndrome
- What is being tested?
- Bifidobacterium adolescentis PRL2019
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Giannina Gaslini
Genova, Genova, 16147
Clara Malattia, 01056362843, claramalattia@gaslini.org
About this study
Official title: A Prospective, Randomised, Controlled Crossover Study on the Effectiveness of Bifidobacterium Adolescentis PRL2019 in the Treatment of Juvenile Fibromyalgia
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.
Read the detailed description
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.
- Conditions
- Fibromyalgia, Fibromyalgia Syndrome
- Being tested
- Bifidobacterium adolescentis PRL2019, Placebo
- Keywords
- Juvenile Fibromyalgia Syndrome, Probiotics, Gut microbiota, Microbiome modulation, Chronic musculoskeletal pain
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium adolescentis PRL2019Dietary supplement
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.
PlaceboDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Gabapral® followed by Placebo | Experimental | 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. Receives: Dietary Supplement: Bifidobacterium adolescentis PRL2019; Dietary Supplement: Placebo |
| Placebo followed by Gabapral® | Experimental | 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. Receives: Dietary Supplement: Bifidobacterium adolescentis PRL2019; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the start of each treatment period (baseline) to the end of the 12-week treatment period
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Week 0) and end of each 12-week treatment period (Week 12 and Week 30).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Giannina Gaslini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738926
- Sponsor's protocol ID
- IGG-microbiotaFMG
- Acronym
- IGG-microbiota
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ting TV, Barnett K, Lynch-Jordan A, Whitacre C, Henrickson M, Kashikar-Zuck S. 2010 American College of Rheumatology Adult Fibromyalgia Criteria for Use in an Adolescent Female Population with Juvenile Fibromyalgia. J Pediatr. 2016 Feb;169:181-7.e1. doi: 10.1016/j.jpeds.2015.10.011. Epub 2015 Nov 3.
PubMed 26545727Giorgio V, Quatrale G, Mennini M, Piccirillo M, Furio S, Stella G, Ferretti A, Parisi P, Evangelisti M, Felici E, Quitadamo P, Di Nardo G. Bifidobacterium adolescentis PRL2019 in Pediatric Irritable Bowel Syndrome: A Multicentric, Randomized, Double-Blind, Placebo-Controlled Trial. Microorganisms. 2025 Mar 10;13(3):627. doi: 10.3390/microorganisms13030627.
PubMed 40142519Duranti S, Ruiz L, Lugli GA, Tames H, Milani C, Mancabelli L, Mancino W, Longhi G, Carnevali L, Sgoifo A, Margolles A, Ventura M, Ruas-Madiedo P, Turroni F. Bifidobacterium adolescentis as a key member of the human gut microbiota in the production of GABA. Sci Rep. 2020 Aug 24;10(1):14112. doi: 10.1038/s41598-020-70986-z.
PubMed 32839473Aslan CIn NN, Acik M, TertemIz OF, Aktan C, Akcali DT, Cakiroglu FP, OzcelIk AO. Effect of prebiotic and probiotic supplementation on reduced pain in patients with fibromyalgia syndrome: a double-blind, placebo-controlled randomized clinical trial. Psychol Health Med. 2024 Mar;29(3):528-541. doi: 10.1080/13548506.2023.2216464. Epub 2023 May 24.
PubMed 37224267Roman P, Estevez AF, Miras A, Sanchez-Labraca N, Canadas F, Vivas AB, Cardona D. A Pilot Randomized Controlled Trial to Explore Cognitive and Emotional Effects of Probiotics in Fibromyalgia. Sci Rep. 2018 Jul 19;8(1):10965. doi: 10.1038/s41598-018-29388-5.
PubMed 30026567Garofalo C, Cristiani CM, Ilari S, Passacatini LC, Malafoglia V, Viglietto G, Maiuolo J, Oppedisano F, Palma E, Tomino C, Raffaeli W, Mollace V, Muscoli C. Fibromyalgia and Irritable Bowel Syndrome Interaction: A Possible Role for Gut Microbiota and Gut-Brain Axis. Biomedicines. 2023 Jun 13;11(6):1701. doi: 10.3390/biomedicines11061701.
PubMed 37371796Lavarello C, Ancona S, Malattia C. Juvenile Primary Fibromyalgia Syndrome: Advances in Etiopathogenesis, Clinical Assessment and Treatment: A Narrative Review. Biomedicines. 2025 May 10;13(5):1168. doi: 10.3390/biomedicines13051168.
PubMed 40426996
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised, Controlled Crossover Study on the Effectiveness of Bifidobacterium Adolescentis PRL2019 in the Treatment of Juvenile Fibromyalgia
- ClinicalTrials.gov ID
- NCT07738926
- Acronym / sponsor ID
- IGG-microbiota / IGG-microbiotaFMG
- Conditions
- Fibromyalgia, Fibromyalgia Syndrome
- Keywords
- Juvenile Fibromyalgia Syndrome, Probiotics, Gut microbiota, Microbiome modulation, Chronic musculoskeletal pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istituto Giannina GasliniUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapral® followed by Placebo | Experimental | Dietary Supplement: Bifidobacterium adolescentis PRL2019, Dietary Supplement: PlaceboParticipants 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. |
| Placebo followed by Gabapral® | Experimental | Dietary Supplement: Bifidobacterium adolescentis PRL2019, Dietary Supplement: PlaceboParticipants 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. |
Who may qualify
- Ages
- 9 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bifidobacterium adolescentis PRL2019Gabapral® 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. | Dietary supplement | Gabapral® followed by Placebo, Placebo followed by Gabapral® |
| PlaceboMatching 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. | Dietary supplement | Gabapral® followed by Placebo, Placebo followed by Gabapral® |
Primary outcome
To evaluate the clinical effectiveness of Gabapral® in reducing musculoskeletal pain in paediatric patients with JFS.
Time frame: From the start of each treatment period (baseline) to the end of the 12-week treatment period
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.
11 secondary outcomes
To assess changes in abdominal pain intensity following treatment with Gabapral®
Time frame: Change from baseline to the end of each 12-week treatment period
To assess changes in fatigue intensity following treatment with Gabapral®
Time frame: Change from baseline to the end of each 12-week treatment period
To assess changes in functional measures following treatment with Gabapral®
Time frame: Change from baseline to the end of each 12-week treatment period
To assess changes in headache intensity following treatment with Gabapral®
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®
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®
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®
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®.
Time frame: Change from baseline to the end of each 12-week treatment period
To assess changes in anxiety symptoms following treatment with Gabapral®
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.
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.
Time frame: Baseline (Week 0) and end of each 12-week treatment period (Week 12 and Week 30).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Background: PubMed 26545727Ting TV, Barnett K, Lynch-Jordan A, Whitacre C, Henrickson M, Kashikar-Zuck S. 2010 American College of Rheumatology Adult Fibromyalgia Criteria for Use in an Adolescent Female Population with Juvenile Fibromyalgia. J Pediatr. 2016 Feb;169:181-7.e1. doi: 10.1016/j.jpeds.2015.10.011. Epub 2015 Nov 3.
- Background: PubMed 40142519Giorgio V, Quatrale G, Mennini M, Piccirillo M, Furio S, Stella G, Ferretti A, Parisi P, Evangelisti M, Felici E, Quitadamo P, Di Nardo G. Bifidobacterium adolescentis PRL2019 in Pediatric Irritable Bowel Syndrome: A Multicentric, Randomized, Double-Blind, Placebo-Controlled Trial. Microorganisms. 2025 Mar 10;13(3):627. doi: 10.3390/microorganisms13030627.
- Background: PubMed 32839473Duranti S, Ruiz L, Lugli GA, Tames H, Milani C, Mancabelli L, Mancino W, Longhi G, Carnevali L, Sgoifo A, Margolles A, Ventura M, Ruas-Madiedo P, Turroni F. Bifidobacterium adolescentis as a key member of the human gut microbiota in the production of GABA. Sci Rep. 2020 Aug 24;10(1):14112. doi: 10.1038/s41598-020-70986-z.
- Background: PubMed 37224267Aslan CIn NN, Acik M, TertemIz OF, Aktan C, Akcali DT, Cakiroglu FP, OzcelIk AO. Effect of prebiotic and probiotic supplementation on reduced pain in patients with fibromyalgia syndrome: a double-blind, placebo-controlled randomized clinical trial. Psychol Health Med. 2024 Mar;29(3):528-541. doi: 10.1080/13548506.2023.2216464. Epub 2023 May 24.
- Background: PubMed 30026567Roman P, Estevez AF, Miras A, Sanchez-Labraca N, Canadas F, Vivas AB, Cardona D. A Pilot Randomized Controlled Trial to Explore Cognitive and Emotional Effects of Probiotics in Fibromyalgia. Sci Rep. 2018 Jul 19;8(1):10965. doi: 10.1038/s41598-018-29388-5.
- Background: PubMed 37371796Garofalo C, Cristiani CM, Ilari S, Passacatini LC, Malafoglia V, Viglietto G, Maiuolo J, Oppedisano F, Palma E, Tomino C, Raffaeli W, Mollace V, Muscoli C. Fibromyalgia and Irritable Bowel Syndrome Interaction: A Possible Role for Gut Microbiota and Gut-Brain Axis. Biomedicines. 2023 Jun 13;11(6):1701. doi: 10.3390/biomedicines11061701.
- Background: PubMed 40426996Lavarello C, Ancona S, Malattia C. Juvenile Primary Fibromyalgia Syndrome: Advances in Etiopathogenesis, Clinical Assessment and Treatment: A Narrative Review. Biomedicines. 2025 May 10;13(5):1168. doi: 10.3390/biomedicines13051168.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium adolescentis PRL2019 in people with Fibromyalgia and Fibromyalgia Syndrome, run by Istituto Giannina Gaslini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clara Malattia (010 5636 2843, claramalattia@gaslini.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the clinical effectiveness of Gabapral® in reducing musculoskeletal pain in paediatric patients with JFS. (time frame: From the start of each treatment period (baseline) to the end of the 12-week treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07738926, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.