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

NCT07582965 | Completed

• 1 other identifier: IIBSP-FIB-2020-08
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia (FM)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Pain from baseline to Week 12, assessed using the Visual Analogue Scale (VAS).

  From baseline to Week 12

• Fatigue from baseline to Week 12, assessed using Fibromyalgia Impact Questionnaire (FIQ).

  From baseline to Week 12

• Sleep quality

  Baseline to Week 12

• Anxiety and depression

  Baseline to Week 12

• Health-related quality of life

  Baseline to Week 12

Study Arms (2)

Probiotic Intervention Group

EXPERIMENTAL

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)

Placebo arm

PLACEBO COMPARATOR

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

Interventions

Placebo OTHER

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.

Placebo arm

Multispecies Probiotic (Teoliance HPi10) DIETARY_SUPPLEMENT

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.

Probiotic Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hospital de Sant Pau

Barcelona, Spain

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant Physician, PhD, Principal Investigator

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 13, 2026
• Study Start: November 27, 2020
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)