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

• ClinicalTrials.gov Identifier: NCT04435886
• Recruitment Status: Recruiting
• First Posted: June 17, 2020
• Last Update Posted: July 10, 2020
• Sponsor: Biopolis S.L.
• Information provided by (Responsible Party): Biopolis S.L.

Tracking Information

• First Submitted Date: June 15, 2020
• First Posted Date: June 17, 2020
• Last Update Posted Date: July 10, 2020
• Actual Study Start Date: March 2, 2020
• Estimated Primary Completion Date: February 2, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 8, 2020)

• Score on the Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: 4-week ]
  Score on the Fibromyalgia Impact Questionnaire (FIQ) in weeks 4
• Score on the Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: 8-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 8
• Score on the Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: 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.

Original Primary Outcome Measures (submitted: June 15, 2020)

• Score on the Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: 4-week ]
  Score on the Fibromyalgia Impact Questionnaire (FIQ) in weeks 4
• Score on the Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: 8-week ]
  Score on the Fibromyalgia Impact Questionnaire (FIQ), in weeks 8
• Score on the Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: 12-week ]
  Score on the Fibromyalgia Impact Questionnaire (FIQ), in weeks 12.

Current Secondary Outcome Measures (submitted: July 8, 2020)

• Score on the Hospital Anxiety and Depression Scale (HAD) [ Time Frame: 4 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 4
• Score on the Hospital Anxiety and Depression Scale (HAD) [ Time Frame: 8 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 8
• Score on the Hospital Anxiety and Depression Scale (HAD) [ Time Frame: 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.
• Visual Analogical Pain Scale (VAS) Score [ Time Frame: 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 [ Time Frame: 4 weeks ]
  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)
• Changes to a patient's usual medical treatment for fibromyalgia [ Time Frame: 8 weeks ]
  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)
• Changes to a patient's usual medical treatment for fibromyalgia [ Time Frame: 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 [ Time Frame: 4 weeks ]
  Treatment adherence rate using the returned capsules, in weeks 4
• Treatment adherence rate [ Time Frame: 8 weeks ]
  Treatment adherence rate using the returned capsules, in weeks 8
• Treatment adherence rate [ Time Frame: 12 weeks ]
  Treatment adherence rate using the returned capsules, in weeks 12
• Number of adverse events [ Time Frame: 4 weeks ]
  Numbre od adverse effects reported, 4 weeks
• Number of adverse events [ Time Frame: 8 weeks ]
  Numbre od adverse effects reported, 8 weeks
• Number of adverse events [ Time Frame: 12 weeks ]
  Numbre od adverse effects reported, 12 weeks

Original Secondary Outcome Measures (submitted: June 15, 2020)

• Score on the Hospital Anxiety and Depression Scale (HAD) [ Time Frame: 4 weeks ]
  Score on the Hospital Anxiety and Depression Scale (HAD), in weeks 4
• Score on the Hospital Anxiety and Depression Scale (HAD) [ Time Frame: 8 weeks ]
  Score on the Hospital Anxiety and Depression Scale (HAD), in weeks 8
• Score on the Hospital Anxiety and Depression Scale (HAD) [ Time Frame: 12 weeks ]
  Score on the Hospital Anxiety and Depression Scale (HAD), in weeks 12.
• Visual Analogical Pain Scale (VAS) Score [ Time Frame: 12 weeks ]
  Visual Analogical Pain Scale (VAS) Score, in weeks 12
• Changes to a patient's usual medical treatment for fibromyalgia [ Time Frame: 4 weeks ]
  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)
• Changes to a patient's usual medical treatment for fibromyalgia [ Time Frame: 8 weeks ]
  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)
• Changes to a patient's usual medical treatment for fibromyalgia [ Time Frame: 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 [ Time Frame: 4 weeks ]
  Treatment adherence rate using the returned capsules, in weeks 4
• Treatment adherence rate [ Time Frame: 8 weeks ]
  Treatment adherence rate using the returned capsules, in weeks 8
• Treatment adherence rate [ Time Frame: 12 weeks ]
  Treatment adherence rate using the returned capsules, in weeks 12
• Number of adverse events [ Time Frame: 4 weeks ]
  Numbre od adverse effects reported, 4 weeks
• Number of adverse events [ Time Frame: 8 weeks ]
  Numbre od adverse effects reported, 8 weeks
• Number of adverse events [ Time Frame: 12 weeks ]
  Numbre od adverse effects reported, 12 weeks

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Use of a Probiotic in the Treatment of Fibromyalgia (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

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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

12-week randomized, double-blind, parallel-group, placebo-controlled study

Masking: Double (Participant, Investigator)
Masking Description:

Double-blind

Primary Purpose: Treatment

• Condition: Fibromyalgia

Intervention

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

Study Arms

• Experimental: Probiotic group
  A multi-strain probiotic
  Intervention: Dietary Supplement: Probiotic
• Placebo Comparator: Placebo group
  Identical placebo
  Intervention: Dietary Supplement: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 15, 2020): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2, 2021
• Estimated Primary Completion Date: February 2, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: María Empar Chenoll, PhD; +34 673 53 53 44; maria.chenoll@adm.com

• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT04435886
• Other Study ID Numbers: FIBRO.PROB
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Biopolis S.L.
• Study Sponsor: Biopolis S.L.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Biopolis S.L.
• Verification Date: June 2020