This study aims to understand the efficacy of two probiotic interventions as prophylaxes of fibromyalgia symptoms in individuals diagnosed. The primary outcome measure will be the progression and treatment of fibromyalgia, defined as a decrease in the Fibromyalgia Impact Questionnaire (FIQ) score, other otucomes will be the effect on the symptoms of anxiety and depression associated with fibromyalgia, defined as a decrease in the Hospital Anxiety and Depression Scale (HAD) score; perception of pain by scoring on a Visual Analogical Pain Scale (VAS), and differences in the patient's usual medical treatment. Finally adverse effects will be evaluated. The study will have two arms: one arm including a probiotic preparation and a placebo arm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Probiotic mixture with maltodextrin as a carrier.
Placebo comparator with maltodextrin as a carrier.
Hospital Universitario de Vinalopó
Elche, Alicante, Spain
RECRUITINGScore on the Fibromyalgia Impact Questionnaire (FIQ)
Score on the Fibromyalgia Impact Questionnaire (FIQ) in weeks 4
Time frame: 4-week
Score on the Fibromyalgia Impact Questionnaire (FIQ)
Score on the Fibromyalgia Impact Questionnaire (FIQ), The score range is form 0 to 100, where each question has an score from 0 to 10. Higher scores refers a higher impact of fybromialgia in lifestile where 0 is the best functional capacity and higher quality of life and 100 the worst stat, in weeks 8
Time frame: 8-week
Score on the Fibromyalgia Impact Questionnaire (FIQ)
Score on the Fibromyalgia Impact Questionnaire (FIQ), The score range is form 0 to 100, where each question has an score from 0 to 10. Higher scores refers a higher impact of fybromialgia in lifestile where 0 is the best functional capacity and higher quality of life and 100 the worst stat, in weeks 12.
Time frame: 12-week
Score on the Hospital Anxiety and Depression Scale (HAD)
Score on the Hospital Anxiety and Depression Scale (HAD), To determine the levels of anxiety and depression that a person is experiencing. It is a fourteen item scale; seven items are related to anxiety and seven to depression. Each item is scored from 0-3, being the total score from 0 to 21 for either anxiety or depression. The higher score the worse state. in weeks 4
Time frame: 4 weeks
Score on the Hospital Anxiety and Depression Scale (HAD)
Score on the Hospital Anxiety and Depression Scale (HAD), To determine the levels of anxiety and depression that a person is experiencing. It is a fourteen item scale; seven items are related to anxiety and seven to depression. Each item is scored from 0-3, being the total score from 0 to 21 for either anxiety or depression. The higher score the worse state. In weeks 8
Time frame: 8 weeks
Score on the Hospital Anxiety and Depression Scale (HAD)
Score on the Hospital Anxiety and Depression Scale (HAD), To determine the levels of anxiety and depression that a person is experiencing. It is a fourteen item scale; seven items are related to anxiety and seven to depression. Each item is scored from 0-3, being the total score from 0 to 21 for either anxiety or depression. The higher score the worse state. In weeks 12.
Time frame: 12 weeks
Visual Analogical Pain Scale (VAS) Score
Visual Analogical Pain Scale (VAS) Score. It is a unidimensional continuous measure of pain intensity. It comprises a horizontal (HVAS) or vertical (VVAS) line, 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[100-mm scale\]). in weeks 12
Time frame: 12 weeks
Changes to a patient's usual medical treatment for fibromyalgia
Changes to a patient's usual medical treatment for fibromyalgia, in weeks 4 Little or no impact (46 or less) Some impact (50 -55) Substantial impact (56-59) Severe impact (60-78)
Time frame: 4 weeks
Changes to a patient's usual medical treatment for fibromyalgia
Changes to a patient's usual medical treatment for fibromyalgia, in weeks 8 Little or no impact (46 or less) Some impact (50 -55) Substantial impact (56-59) Severe impact (60-78)
Time frame: 8 weeks
Changes to a patient's usual medical treatment for fibromyalgia
Changes to a patient's usual medical treatment for fibromyalgia, in weeks 12 Little or no impact (46 or less) Some impact (50 -55) Substantial impact (56-59) Severe impact (60-78)
Time frame: 12 weeks
Treatment adherence rate
Treatment adherence rate using the returned capsules, in weeks 4
Time frame: 4 weeks
Treatment adherence rate
Treatment adherence rate using the returned capsules, in weeks 8
Time frame: 8 weeks
Treatment adherence rate
Treatment adherence rate using the returned capsules, in weeks 12
Time frame: 12 weeks
Number of adverse events
Numbre od adverse effects reported, 4 weeks
Time frame: 4 weeks
Number of adverse events
Numbre od adverse effects reported, 8 weeks
Time frame: 8 weeks
Number of adverse events
Numbre od adverse effects reported, 12 weeks
Time frame: 12 weeks
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