CompletedNot Applicable

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

Spain97 participantsStarted 2020-11-27

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline to Week 12

Trial details

NCT IDNCT07582965

SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-31

View on ClinicalTrials.gov More Fibromyalgia (FM) trials