Probiotics for Cognitive Function, Pain, and Quality of Life in People With Fibromyalgia
7 mei 2026 bijgewerkt door: Irene Fernánde Castaño, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Estudio Piloto, Prospectivo, Randomizado, Doble Ciego Para Estudiar el Efecto Sobre función Cognitiva, Dolor y Calidad de Vida de un Tratamiento Con probióticos en Pacientes Con Fibromialgia.
Fibromyalgia is a complex chronic disorder in which emerging evidence suggests a relevant role of the gut microbiota in modulating physiological processes through the gut-brain axis. In this context, probiotics have been proposed as a potential therapeutic strategy for symptom management in fibromyalgia.
This study aimed to evaluate the effects of a multispecies probiotic formulation administered over 12 weeks on pain and fatigue in patients with fibromyalgia. Secondary outcomes included sleep disturbances, cognitive function, and emotional symptoms.
This was a quadruple-blinded, randomized, placebo-controlled clinical trial. Participants were randomly assigned to receive either a daily capsule of a multispecies probiotic (Teoliance HPi10, Therascience) containing Lactobacillus acidophilus LA-3, Lactobacillus rhamnosus GG, Bifidobacterium BS01, Lactobacillus plantarum BG112, Streptococcus thermophilus SP4, Lactobacillus casei LCO3, and Lactobacillus reuteri LR92, or placebo, for 12 weeks. Clinical outcomes were assessed using validated questionnaires including VAS, BPI, SF-36, MOS, HADS, and FIQ.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
97
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
-
Barcelona, Spanje
- Hospital de Sant Pau
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- Female participants aged 18 years or older.
- Diagnosis of fibromyalgia (severity grade 1-4) according to the American College of Rheumatology (ACR) criteria, established at least 1 year prior to enrollment.
- Body mass index (BMI) < 30 kg/m².
- Ability and willingness to provide written informed consent.
Exclusion Criteria:
- Pregnancy or breastfeeding.
- Use of probiotics within 6 months prior to study enrollment.
- Use of antibiotics within 6 months prior to study enrollment.
- History of inflammatory bowel disease.
- Pre-existing psychiatric disorder diagnosed prior to fibromyalgia diagnosis.
- Active cancer.
- History of gastrointestinal cancer.
- History of chemotherapy treatment.
- History of radiotherapy in the abdomino-pelvic region.
- Participation in another clinical trial.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Probiotic Intervention Group
Participants in this arm receive a daily oral capsule of a multispecies probiotic (Teoliance HPi10, Therascience) for 12 weeks.
The formulation contains Lactobacillus acidophilus LA-3, Lactobacillus rhamnosus GG, Bifidobacterium animalis subsp.
lactis BS01, Lactobacillus plantarum BG112, Streptococcus thermophilus SP4, Lactobacillus casei LCO3, and Lactobacillus reuteri LR92.
The intervention is administered once daily.
|
Participants receive a daily oral capsule of a multispecies probiotic formulation (Teoliance HPi10, Therascience) for 12 weeks.
Each capsule contains Lactobacillus acidophilus LA-3, Lactobacillus rhamnosus GG, Bifidobacterium animalis subsp.
lactis BS01, Lactobacillus plantarum BG112, Streptococcus thermophilus SP4, Lactobacillus casei LCO3, and Lactobacillus reuteri LR92 (approximately 10⁹ CFU per capsule).
The intervention is administered once daily.
|
|
Placebo-vergelijker: Placebo arm
Participants in this arm receive a matching placebo capsule administered orally once daily for 12 weeks.
The placebo is identical in appearance to the active intervention but does not contain any active probiotic strains.
|
Participants receive a matching placebo capsule identical in appearance to the active product but without active probiotic strains, administered orally once daily for 12 weeks.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Pain from baseline to Week 12, assessed using Fibromyalgia Impact Questionnaire (FIQ).
Tijdsspanne: Baseline to Week 12
|
Change from baseline to Week 12 in pain intensity in patients with fibromyalgia.
Pain intensity will be assessed using the Fibromyalgia Impact Questionnaire (FIQ 0-100).
The primary endpoint will be the between-group difference in change over time (Group × Time interaction).
|
Baseline to Week 12
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Pain from baseline to Week 12, assessed using the Visual Analogue Scale (VAS).
Tijdsspanne: From baseline to Week 12
|
Change from baseline to Week 12 in pain intensity in patients with fibromyalgia.
Pain intensity will be assessed using the Visual Analogue Scale (VAS; 0-10).
The primary endpoint will be the between-group difference in change over time (Group × Time interaction).
|
From baseline to Week 12
|
|
Fatigue from baseline to Week 12, assessed using Fibromyalgia Impact Questionnaire (FIQ).
Tijdsspanne: From baseline to Week 12
|
Change from baseline to Week 12 in fatigue severity in patients with fibromyalgia.
Fatigue severity will be evaluated using validated patient-reported outcome measures, including the Fibromyalgia Impact Questionnaire (FIQ 0-100).
The primary endpoint will be the between-group difference in change over time (Group × Time interaction).
|
From baseline to Week 12
|
|
Sleep quality
Tijdsspanne: Baseline to Week 12
|
Sleep quality will be assessed using the Medical Outcomes Study Sleep Scale (MOS-Sleep 0-100).
This validated questionnaire evaluates multiple dimensions of sleep, including sleep disturbance, sleep adequacy, somnolence, and snoring.
Higher scores indicate poorer sleep quality.
Assessments will be performed at baseline and Week 12.
|
Baseline to Week 12
|
|
Anxiety and depression
Tijdsspanne: Baseline to Week 12
|
Anxiety and depressive symptoms will be assessed using the Hospital Anxiety and Depression Scale (HADS).
This instrument includes two subscales (anxiety and depression), each ranging from 0 to 21, with higher scores indicating greater symptom severity.
Scores ≥8 on either subscale indicate clinically relevant symptoms.
Assessments will be performed at baseline and Week 12.
|
Baseline to Week 12
|
|
Health-related quality of life
Tijdsspanne: Baseline to Week 12
|
Health-related quality of life will be measured using the Short Form-36 Health Survey (SF-36).
This instrument assesses eight domains of physical and mental health, with scores standardized from 0 to 100, where higher scores indicate better quality of life.
Assessments will be performed at baseline and Week 12.
|
Baseline to Week 12
|
|
Fibromyalgia impact
Tijdsspanne: Baseline to Week 12
|
The overall impact of fibromyalgia will be assessed using the Fibromyalgia Impact Questionnaire (FIQ 0-100), which evaluates physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and overall well-being.
Higher scores indicate greater disease impact.
Assessments will be performed at baseline and Week 12.
|
Baseline to Week 12
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
27 november 2020
Primaire voltooiing (Werkelijk)
31 oktober 2023
Studie voltooiing (Werkelijk)
31 oktober 2023
Studieregistratiedata
Eerst ingediend
16 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
7 mei 2026
Eerst geplaatst (Werkelijk)
13 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
13 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
7 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IIBSP-FIB-2020-08
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
Individual participant data (IPD) will not be shared.
The data generated in this study will remain under the responsibility of the sponsor and will not be made publicly available or shared with external researchers.
Results will be disseminated in aggregated form through peer-reviewed publications and scientific communications.
This decision is based on data protection considerations and the exploratory nature of the study.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .