At a glance
ClinicalIndex Comparison RecordN/ACompleted· 110 enrolled
Drug / intervention
VSL#3 +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating VSL#3 and Placebo for Fibromyalgia and Gastrointestinal Disease. Completed, enrolled 110 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia, Gastrointestinal Disease
CountriesSpain
CollaboratorsActial Farmaceutica S.r.l., Ferring Pharmaceuticals
Timeline
N/ACompletedFinished
20192020202120222023202420252026
Enrollment StartMay 2018
First PostedFeb 2020
Primary CompletionMay 2020
TodayJul 2026
First PostedFeb 5, 2020
Enrollment StartMay 11, 2018
Primary CompletionMay 31, 2020
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 6.4 years ago
Interventions
VSL#3dietary
sachets containing probiotic
Placebodietary
sachets containing placebo