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NCT07738926

Overview

NCT ID: NCT07738926
Lead Sponsor: Istituto Giannina GasliniOTHER
Official Title: A Prospective, Randomised, Controlled Crossover Study on the Effectiveness of Bifidobacterium Adolescentis PRL2019 in the Treatment of Juvenile Fibromyalgia
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

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 31, 2026Actual
Start Date: Aug 1, 2026Estimated
Primary Completion Date: Sep 1, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 30Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Quadruple

Contacts and Locations

Central Contacts: Clara MalattiaContact
claramalattia@gaslini.org010 5636 2843

Similar Studies

Participant Group/Arms

Gabapral® followed by PlaceboExperimental

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