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

Elena Pita Calandre

Status: Completed

Conditions: Gastrointestinal Disease; Fibromyalgia

Treatments: Dietary Supplement: VSL#3; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04256785

FMS-VSL3-19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

110 participants in 2 patient groups, including a placebo group

VSL#3

Experimental group

Description:

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

Treatment:

Dietary Supplement: VSL#3

placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo