MedTrace Logo

Probiotic VSL#3 for the Treatment of Gastrointestinal Symptoms Associated to Fibromyalgia

NCT04256785 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2021-08-02

Study results available
· View outcomes & findings →

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.

Conditions

  • Fibromyalgia
  • Gastrointestinal Disease

Interventions

DIETARY_SUPPLEMENT

VSL#3

sachets containing probiotic

DIETARY_SUPPLEMENT

Placebo

sachets containing placebo

Sponsors & Collaborators

  • Actial Farmaceutica S.r.l.

    collaborator INDUSTRY

  • Ferring Pharmaceuticals

    collaborator INDUSTRY

  • Elena Pita Calandre

    lead OTHER

Principal Investigators

  • Elena P. Calandre, M.D. · Universidad de Granada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-11
Primary Completion
2020-05-31
Completion
2020-05-31

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04256785 on ClinicalTrials.gov