Probiotics and Prebiotics as a Potential Treatment in Fibromyalgia Patients: A Randomized, Double-Blinded, Placebo-Controlled
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ankara University
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Fibromyalgia Impact Questionnaire (FIQ)
Study Overview
Brief Summary
The aim of the present study is to determine the effectiveness of probiotic and prebiotic treatments in patients with fibromyalgia syndrome.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Patients and investigators are double-blinded
Eligibility Criteria
- Ages
- 21 Years to 64 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Placebo
It was composed of maltodextrin, and provided by the manufacturer Fibrelle; (Belgium). The prescription was similar to probiotics or prebiotics groups.
Intervention: Placebo (Dietary Supplement)
Prebiotic
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.
Intervention: Prebiotic (Dietary Supplement)
Probiotic
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.
Intervention: Probiotic (Dietary Supplement)
Outcomes
Primary Outcomes
Fibromyalgia Impact Questionnaire (FIQ)
Time Frame: 8 weeks
Fibromyalgia Impact Questionnaire (FIQ) form is a evaluate the functional status of the patients. In this scale, 10 different features are measured: physical function, well-being, not being able to go to work, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression. The scale is scored range 0-100. Low scores indicated recovery except for the feeling of well-being.
Secondary Outcomes
- Visual Analogue Scale (VAS)(8 weeks)
- Beck Depression Inventory (BDI)(8 weeks)
- Beck Anxiety Inventory (BAI)(8 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(8 weeks)
- SF-36 Quality of Life(8 weeks)
Investigators
Nazlı Nur ASLAN ÇİN, PhD
Research Assistant in Department of Nutrition and Dietetics
Ankara University