Use of a Probiotic in the Treatment of Fibromyalgia (FIBROPROB)

Not Applicable

• Conditions: Fibromyalgia
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Probiotic

• Registration Number: NCT04435886
• Lead Sponsor: Biopolis S.L.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-02
• Status Verified: 2020-06
• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-06-15
• Study First Posted: 2020-06-17
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-10
• Primary Completion: 2021-02-02
• Study Completion: 2021-05-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Age between 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

Exclusion Criteria

11. Women who are pregnant, breastfeeding or who do not commit to using an effective method of contraception during the course of the study.

12. Known allergy to any of the components of the study product or the placebo. 3. Consumption of antibiotics in the 2 weeks prior to the start of the study. 4. Consumption of probiotics in the 2 months prior to the start of the study. 5. Evidence of neuropsychiatric disorders including: Parkinson's disease, psychotic disorder, bipolar depression 6. Regular consumption of alcohol in excess of 45 g ethanol/day in the year prior to study inclusion.

13. Any concurrent malignant pathology known at the time of inclusion in the study or serious metabolic, cardiovascular, renal, hepatic or gastrointestinal diseases which may lead to non-completion of the study according to the investigator's criteria.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Identical placebo
Probiotic group	Probiotic	A multi-strain probiotic

Primary Outcome Measures

Name	Time	Method
Score on the Fibromyalgia Impact Questionnaire (FIQ)	12-week	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.

Secondary Outcome Measures

Name	Time	Method
Score on the Hospital Anxiety and Depression Scale (HAD)	12 weeks	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.
Number of adverse events	12 weeks	Numbre od adverse effects reported, 12 weeks
Visual Analogical Pain Scale (VAS) Score	12 weeks	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
Changes to a patient's usual medical treatment for fibromyalgia	12 weeks	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)
Treatment adherence rate	12 weeks	Treatment adherence rate using the returned capsules, in weeks 12

Trial Locations

Locations (1)

Hospital Universitario de Vinalopó; 🇪🇸 Elche, Alicante, Spain