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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04435886
Recruitment Status : Recruiting
First Posted : June 17, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Fibromyalgia Dietary Supplement: Probiotic Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Official Title: A 12-weeks Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of a Probiotic in the Treatment of Fibromyalgia
Actual Study Start Date : March 2, 2020
Estimated Primary Completion Date : February 2, 2021
Estimated Study Completion Date : May 2, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

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.




Primary Outcome Measures :
  1. Score on the Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: 4-week ]
    Score on the Fibromyalgia Impact Questionnaire (FIQ) in weeks 4

  2. 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

  3. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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)

  6. 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)

  7. 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)

  8. Treatment adherence rate [ Time Frame: 4 weeks ]
    Treatment adherence rate using the returned capsules, in weeks 4

  9. Treatment adherence rate [ Time Frame: 8 weeks ]
    Treatment adherence rate using the returned capsules, in weeks 8

  10. Treatment adherence rate [ Time Frame: 12 weeks ]
    Treatment adherence rate using the returned capsules, in weeks 12

  11. Number of adverse events [ Time Frame: 4 weeks ]
    Numbre od adverse effects reported, 4 weeks

  12. Number of adverse events [ Time Frame: 8 weeks ]
    Numbre od adverse effects reported, 8 weeks

  13. Number of adverse events [ Time Frame: 12 weeks ]
    Numbre od adverse effects reported, 12 weeks



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04435886


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

Locations
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Spain
Hospital Universitario de Vinalopó Recruiting
Elche, Alicante, Spain, 03293
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.         
Sponsors and Collaborators
Biopolis S.L.
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Responsible Party: Biopolis S.L.
ClinicalTrials.gov Identifier: NCT04435886    
Other Study ID Numbers: FIBRO.PROB
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biopolis S.L.:
Probiotic
Fibromyalgia
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases