Probiotics for Cognitive Function, Pain, and Quality of Life in People With Fibromyalgia

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia (FM)
• Intervention / Treatment: Dietary supplement: Multispecies Probiotic (Teoliance HPi10); Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital de Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Multispecies Probiotic (Teoliance HPi10); 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 Comparator: 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.	Other: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain from baseline to Week 12, assessed using Fibromyalgia Impact Questionnaire (FIQ).	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain from baseline to Week 12, assessed using the Visual Analogue Scale (VAS).	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).	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2020
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia
• Other Study ID Numbers: IIBSP-FIB-2020-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No