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

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

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 Overview

• Status: Unknown
• Conditions: Fibromyalgia
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: María Empar Chenoll, PhD; Phone Number: +34 673 53 53 44; Email: maria.chenoll@adm.com

Study Locations

• Spain
  • Alicante
    • Elche, Alicante, Spain, 03293
      • Recruiting
      • Hospital Universitario de Vinalopo
      • Contact: Maria Victoria Soto Borrás
      • Principal Investigator: Maria Victoria Soto Borrás, Dra.
      • Sub-Investigator: Judith Torres Cañete, Dra.
      • Sub-Investigator: Antonio Mas Mas, Dr.
      • Sub-Investigator: Sandra Rufo Carmona, Dra.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic group; A multi-strain probiotic	Dietary supplement: Probiotic; Probiotic mixture with maltodextrin as a carrier.
Placebo Comparator: Placebo group; Identical placebo	Dietary supplement: Placebo; Placebo comparator with maltodextrin as a carrier.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score on the Fibromyalgia Impact Questionnaire (FIQ)	Score on the Fibromyalgia Impact Questionnaire (FIQ) in weeks 4	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	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.	12-week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Treatment adherence rate	Treatment adherence rate using the returned capsules, in weeks 4	4 weeks
Treatment adherence rate	Treatment adherence rate using the returned capsules, in weeks 8	8 weeks
Treatment adherence rate	Treatment adherence rate using the returned capsules, in weeks 12	12 weeks
Number of adverse events	Numbre od adverse effects reported, 4 weeks	4 weeks
Number of adverse events	Numbre od adverse effects reported, 8 weeks	8 weeks
Number of adverse events	Numbre od adverse effects reported, 12 weeks	12 weeks

Collaborators and Investigators

• Sponsor: Biopolis S.L.

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2020
• Primary Completion (Anticipated): February 2, 2021
• Study Completion (Anticipated): May 2, 2021

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: June 15, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Actual): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Fibromyalgia; Probiotic
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: FIBRO.PROB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No