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

Fibromyalgia Clinical Trial

— FIBROPROB  

Official title:

A 12-weeks Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of a Probiotic in the Treatment of Fibromyalgia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04435886
• Other study ID #: FIBRO.PROB
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2020
• Est. completion date: May 2, 2021

Study information

• Verified date: June 2020
• Source: Biopolis S.L.
• Contact: María Empar Chenoll, PhD
• Phone: +34 673 53 53 44
• Email: maria.chenoll[@]adm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2, 2021
• Est. primary completion date: February 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

2. 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.

7. 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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Dietary Supplement:
• Probiotic
Probiotic mixture with maltodextrin as a carrier.
• Placebo
Placebo comparator with maltodextrin as a carrier.

Locations

Country	Name	City	State
Spain	Hospital Universitario de Vinalopó	Elche	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Biopolis S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on the Fibromyalgia Impact Questionnaire (FIQ)	Score on the Fibromyalgia Impact Questionnaire (FIQ) in weeks 4	4-week
Primary	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	8-week
Primary	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.	12-week
Secondary	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	4 weeks
Secondary	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	8 weeks
Secondary	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.	12 weeks
Secondary	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	12 weeks
Secondary	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)	4 weeks
Secondary	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)	8 weeks
Secondary	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)	12 weeks
Secondary	Treatment adherence rate	Treatment adherence rate using the returned capsules, in weeks 4	4 weeks
Secondary	Treatment adherence rate	Treatment adherence rate using the returned capsules, in weeks 8	8 weeks
Secondary	Treatment adherence rate	Treatment adherence rate using the returned capsules, in weeks 12	12 weeks
Secondary	Number of adverse events	Numbre od adverse effects reported, 4 weeks	4 weeks
Secondary	Number of adverse events	Numbre od adverse effects reported, 8 weeks	8 weeks
Secondary	Number of adverse events	Numbre od adverse effects reported, 12 weeks	12 weeks