Probiotics: Clinical Intervention Trial in Patients With Fibromyalgia

Pablo Román López

Status: Completed

Conditions: Fibromyalgia

Treatments: Other: Placebo; Dietary Supplement: Lactobacillus Rhamnosus GG ®; Dietary Supplement: Lactobacillus acidophilus

Study type: Interventional

Funder types: Other

Identifiers

NCT02642289

UAL-270415

Details and patient eligibility

About

This study evaluates the benefits of probiotics in patients with fibromyalgia syndrome.

Full description

Probiotics has demonstrated to be effective in the management of anxiety and depression. Although these results are promising, more research is needed to explore the role of probiotics to improve physical, emotional and cognitive processes in different clinical populations that are associated with altered microbiome. Thus, the main aim of the present project is to explore whether the oral intake of probiotics might provide benefits to a group of patients with fibromyalgia.

The investigators expect to found significant differences between some physical, emotional and cognitive measures assessed pre- and post-treatment demonstrating the effects of microbiota on the Central Nervous System as well as its potential as a therapeutic tool for the treatment of Fibromyalgia.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fibromyalgia syndrome diagnosis.
• No treatment with antibiotic.
• More than a year of diagnosis
• Agreement to participate in the study.

Exclusion criteria

• Severe physical disability.
• Malignancy.
• Pregnancy
• Psychiatric illnesses (eg, schizophrenia or substance abuse).
• Medication usage other than as-needed analgesics (excluding long-term narcotics).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

Probiotic1: Lactobacillus acidophilus

Experimental group

Description:

Dietary Supplement: Probiotics 1. 8-week probiotic food-supplement intervention with Lactobacillus acidophilus (Daily intake: 24 millions)

Treatment:

Dietary Supplement: Lactobacillus acidophilus

Placebo

Placebo Comparator group

Description:

Inactivate substance

Treatment:

Other: Placebo

Probiotic2: Lactobacillus Rhamnosus GG ®

Experimental group

Description:

Dietary Supplement: Probiotics 2 8-week probiotic food-supplement intervention with Lactobacillus Rhamnosus (Daily intake: 24 millions)

Treatment:

Dietary Supplement: Lactobacillus Rhamnosus GG ®