PRL2019 in the Treatment of Juvenile Fibromyalgia

NCT07738926 | Not Yet Recruiting DMC

• 1 other identifier: IGG-microbiotaFMG
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibromyalgia; Fibromyalgia Syndrome

Keywords

Juvenile Fibromyalgia Syndrome; Probiotics; Gut microbiota; Microbiome modulation; Chronic musculoskeletal pain

Outcome Measures

Primary Outcomes (1)

• 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.

  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®

  Change from baseline to the end of each 12-week treatment period

• To assess changes in fatigue intensity following treatment with Gabapral®

  Change from baseline to the end of each 12-week treatment period

• To assess changes in functional measures following treatment with Gabapral®

  Change from baseline to the end of each 12-week treatment period

• To assess changes in headache intensity following treatment with Gabapral®

  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®

  From the start of each treatment period (baseline) to the end of the 12-week treatment period

Study Arms (2)

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.

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.

Dietary Supplement: Bifidobacterium adolescentis PRL2019; Dietary Supplement: Placebo

Interventions

Bifidobacterium adolescentis PRL2019 DIETARY_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.

Gabapral® followed by Placebo; Placebo followed by Gabapral®

Placebo DIETARY_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.

Gabapral® followed by Placebo; Placebo followed by Gabapral®

Eligibility Criteria

• Age: 9 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Giannina Gaslini: lead

Study Sites (1)

IRCCS Giannina Gaslini

Genova, Genova, 16147, Italy

Location

Related Publications (7)

• 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.

  PMID: 26545727 BACKGROUND

• Giorgio 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.

  PMID: 40142519 BACKGROUND

• Duranti 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.

  PMID: 32839473 BACKGROUND

• Aslan 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.

  PMID: 37224267 BACKGROUND

• Roman 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.

  PMID: 30026567 BACKGROUND

• Garofalo 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.

  PMID: 37371796 BACKGROUND

• Lavarello 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.

  PMID: 40426996 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Clara Malattia

CONTACT

010 5636 2843; claramalattia@gaslini.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 31, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)