Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

Tracking Information
First Submitted Date  ICMJE June 15, 2020
First Posted Date  ICMJE June 17, 2020
Last Update Posted Date July 10, 2020
Actual Study Start Date  ICMJE March 2, 2020
Estimated Primary Completion Date February 2, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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.
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Use of a Probiotic in the Treatment of Fibromyalgia (FIBROPROB)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE Fibromyalgia
Intervention  ICMJE
  • Dietary Supplement: Probiotic
    Probiotic mixture with maltodextrin as a carrier.
  • Dietary Supplement: Placebo
    Placebo comparator with maltodextrin as a carrier.
Study Arms  ICMJE
  • Experimental: Probiotic group
    A multi-strain probiotic
    Intervention: Dietary Supplement: Probiotic
  • Placebo Comparator: Placebo group
    Identical placebo
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 15, 2020)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2, 2021
Estimated Primary Completion Date February 2, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: María Empar Chenoll, PhD +34 673 53 53 44 maria.chenoll@adm.com
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04435886
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Biopolis S.L.
Study Sponsor  ICMJE Biopolis S.L.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Biopolis S.L.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP