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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-11

Study Completion Date

2020-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of the Symptomatic Improvement in Patients With Fibromyalgia by Means of a Food Supplement

NCT05718908

Fibromyalgia

COMPLETED

The Effect of Probiotic and Prebiotic Use on Fibromyalgia Syndrome

NCT04607278

Fibromyalgia

COMPLETED NA

Evaluating the Added Benefit of Osteopathic Care to a Flexi-FODMAP Diet in Fibromyalgia Patients With Irritable Bowel Syndrome: a Randomized Sham-controlled Trial

NCT07176078

Irritable Bowel Syndrome (IBS) Fibromyalgia (FM)

NOT_YET_RECRUITING NA

Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients

NCT01271933

Fibromyalgia

COMPLETED PHASE3

Effect of PERMEAPROTECT on the Quality of Life of Patients With Fibromyalgia

NCT01469936

Fibromyalgia

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fibromyalgia Gastrointestinal Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

VSL#3

probiotic VSL#3, 2 sachets b.i.d for 3 months

Group Type EXPERIMENTAL

VSL#3

Intervention Type DIETARY_SUPPLEMENT

sachets containing probiotic

placebo

matched placebo, 2 sachets b.i.d for 3 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

sachets containing placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VSL#3

sachets containing probiotic

Intervention Type DIETARY_SUPPLEMENT

Placebo

sachets containing placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No