Clinical trial NCT04256785: Probiotic VSL#3 for the Treatment of Gastrointestinal Symptoms Associated to Fibromyalgia
Official title: Efficacy and Tolerability of the Probiotic VSL#3 for the Treatment of Patients With Fibromyalgia and Associated Gastrointestinal Symptomatology: a Randomized, Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Gastrointestinal Disease
Keywords: probiotic
efficacy
tolerability
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Actial Farmaceutica S.r.l.
name: Ferring Pharmaceuticals
First posted: 2020-02-05
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study evaluated the efficacy and tolerability of probiotic VSL#3 for the treatment of gastrointestinal symptoms in patients with fibromyalgia; 50% of the participants received probiotic and the remaining 50% received matching placebo in a double-blind, randomized design.The treatment was administered during a 12-week period and the participants were followed for an additional 12-week period in order to follow the evolution after treatment.

Detailed description: Many patients with fibromyalgia experience associated gastrointestinal symptomatology such as abdominal pain, abdominal bloating, meteorism, diarrhea and/or constipation. To date there is not any specific treatment for these symptoms that markedly impair the quality of life of these subjects. This trial intended to investigate if the addition of a polymicrobial probiotic product, which has shown efficacy in patients with irritable bowel syndrome, was also be useful to ameliorate the gastrointestinal symptomatology of patients with fibromyalgia.

Eligibility criteria: Inclusion Criteria:

* diagnosed of fibromyalagia
* experiencing at least 3 chronic gastrointestinal symptoms
* signed informed consent to participate
* accept to not change previously prescribed treatment during study duration

Exclusion Criteria:

* mental illness excepting depression
* severe organic disease
* additional gastrointestinal disease excepting irritable bowel syndrome
* pregnancy
* breastfeeding

Primary outcomes:
measure: Change, From Baseline to Endpoint (12 Weeks) in the Composite Score of Abdominal Pain, Abdominal Bloating and Metheorism Each One Measured in a 0-10 Visual Analog Scale
timeFrame: baseline and twelve weeks after treatment
Secondary outcomes:
measure: Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Fibromyalgia Impact Questionnaire Revised (FIQR)
timeFrame: baseline and twelve weeks after treatment
measure: Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Insomnia Severity Inventory (ISI)
timeFrame: baseline and twelve weeks after treatment
measure: Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Patient Health Questionnaire (PHQ-9)
timeFrame: baseline and twelve weeks after treatment
measure: Change, From Baseline to Endpoint (12 Weeks) in the Short-Form Health Survey SF-36 PCS
timeFrame: baseline and twelve weeks after treatment
measure: Change, From Baseline to Endpoint (12 Weeks) in the Short-Form Health Survey SF-36 MCS
timeFrame: baseline and 12 weeks after treatment
measure: Number of Patients Considered as Responders to Treatment
timeFrame: Baseline and 12 weeks after treatment
measure: Change From Week 12 to Week 16 (Follow-up Period) in the Composite Score of Abdominal Pain, Bloating and Metheorism Among Responders After Discontinuing the Study Treatment
timeFrame: Week 12 to week 16
measure: Change From Week 12 to Week 20 (Follow-up Period) in the Composite Score of Abdominal Pain, Bloating and Metheorism Among Responders After Discontinuing the Study Treatment
timeFrame: Week 12 to week 20
measure: Change From Week 12 to Week 24 (Follow-up Period) in the Composite Score of Abdominal Pain, Bloating and Metheorism Among Responders After Discontinuing the Study Treatment
timeFrame: Week 12 to week 24
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Instituto de Neurociencias "Federico Oloriz"
Study officials:
affiliation: Universidad de Granada
name: Elena P. Calandre, M.D.
role: PRINCIPAL_INVESTIGATOR
References: