The Effect of Probiotic and Prebiotic Use on Fibromyalgia Syndrome

Ankara University

Status: Completed

Conditions: Fibromyalgia

Treatments: Dietary Supplement: Prebiotic; Dietary Supplement: Probiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04607278

2019-08/375

Details and patient eligibility

About

The aim of the present study is to determine the effectiveness of probiotic and prebiotic treatments in patients with fibromyalgia syndrome.

Full description

Fifty-three, fibromyalgia syndrome participants were randomized to receive either: 1) probiotic 4×1010 CFUs per day 2) 10 g dose prebiotic (inulin) per day or 3) placebo for 8 wk. Fibromyalgia Impact Questionnaire (FIQ), Visual Analogical Pain Scale (VAS), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Pittsburg Sleep Quality Index (PSQI) and quality of life (SF-36) were measured during the baseline, 4 weeks and 8 weeks intervention phases. Finally, the adverse effects will be evaluated.

Enrollment: 53 patients

Sex: Female

Ages: 21 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women aged 20-65 years.
2. Signature of informed consent by the patient.
3. Patients diagnosed according to the 2010 American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia.
4. Participants should be diagnosed with fibromyalgia at least 1 year ago.

Exclusion criteria

1. using of antibiotic and nutritional supplements
2. being pregnant or breastfeeding
3. the presence of any allergies
4. being involved in any medical or psychological research
5. the presence of severe gastrointestinal diseases
6. psychiatric illness other than depression and anxiety.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 3 patient groups, including a placebo group

Probiotic

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Probiotic

Prebiotic

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Prebiotic

Placebo

Placebo Comparator group

Description:

It was composed of maltodextrin, and provided by the manufacturer Fibrelle; (Belgium). The prescription was similar to probiotics or prebiotics groups.

Treatment:

Dietary Supplement: Placebo