The Effect of Probiotic and Prebiotic Use on Fibromyalgia Syndrome
Fibromyalgia
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring probiotics, prebiotics, fibromyalgia
Eligibility Criteria
Inclusion Criteria:
- Women aged 20-65 years.
- Signature of informed consent by the patient.
- Patients diagnosed according to the 2010 American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia.
- Participants should be diagnosed with fibromyalgia at least 1 year ago.
Exclusion Criteria:
- using of antibiotic and nutritional supplements
- being pregnant or breastfeeding
- the presence of any allergies
- being involved in any medical or psychological research
- the presence of severe gastrointestinal diseases
- psychiatric illness other than depression and anxiety.
Sites / Locations
- Ankara University
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Placebo Comparator
Probiotic
Prebiotic
Placebo
Oral probiotic supplementation (Pro-Probiotic) was provided by iHealth; Cromwell, USA. Each sachet included a 1×1010 CFUs dose of four viable microbial cell preparation strains: there are two strains of lactobacillus genus (Lactobacillus acidophillus L1 (2.9×109) and Lactobacillus rhamnosus liobif (2.9×109)), Bifidobacterium longum (2.9×109) and Saccharomyces boulardii (1.3×109). Each participant took a total daily dose of 4×1010 CFUs.
The prebiotic (Inulin) was made up of inulin from the chicory plant and provided by the Fibrelle (Belgium) company. Five grams packs were given to the participants in boxes. Each participant was requested to take a total daily 10 g dose.
It was composed of maltodextrin, and provided by the manufacturer Fibrelle; (Belgium). The prescription was similar to probiotics or prebiotics groups.