<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04435886</url>
  </required_header>
  <id_info>
    <org_study_id>FIBRO.PROB</org_study_id>
    <nct_id>NCT04435886</nct_id>
  </id_info>
  <brief_title>Use of a Probiotic in the Treatment of Fibromyalgia (FIBROPROB)</brief_title>
  <acronym>FIBROPROB</acronym>
  <official_title>A 12-weeks Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of a Probiotic in the Treatment of Fibromyalgia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biopolis S.L.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biopolis S.L.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to understand the efficacy of two probiotic interventions as prophylaxes of&#xD;
      fibromyalgia symptoms in individuals diagnosed.&#xD;
&#xD;
      The primary outcome measure will be the progression and treatment of fibromyalgia, defined as&#xD;
      a decrease in the Fibromyalgia Impact Questionnaire (FIQ) score, other otucomes will be the&#xD;
      effect on the symptoms of anxiety and depression associated with fibromyalgia, defined as a&#xD;
      decrease in the Hospital Anxiety and Depression Scale (HAD) score; perception of pain by&#xD;
      scoring on a Visual Analogical Pain Scale (VAS), and differences in the patient's usual&#xD;
      medical treatment. Finally adverse effects will be evaluated.&#xD;
&#xD;
      The study will have two arms: one arm including a probiotic preparation and a placebo arm.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 2, 2020</start_date>
  <completion_date type="Anticipated">May 2, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 2, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>12-week randomized, double-blind, parallel-group, placebo-controlled study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Double-blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Score on the Fibromyalgia Impact Questionnaire (FIQ)</measure>
    <time_frame>4-week</time_frame>
    <description>Score on the Fibromyalgia Impact Questionnaire (FIQ) in weeks 4</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Score on the Fibromyalgia Impact Questionnaire (FIQ)</measure>
    <time_frame>8-week</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Score on the Fibromyalgia Impact Questionnaire (FIQ)</measure>
    <time_frame>12-week</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Score on the Hospital Anxiety and Depression Scale (HAD)</measure>
    <time_frame>4 weeks</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score on the Hospital Anxiety and Depression Scale (HAD)</measure>
    <time_frame>8 weeks</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score on the Hospital Anxiety and Depression Scale (HAD)</measure>
    <time_frame>12 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogical Pain Scale (VAS) Score</measure>
    <time_frame>12 weeks</time_frame>
    <description>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 &quot;no pain&quot; (score of 0) and &quot;pain as bad as it could be&quot; or &quot;worst imaginable pain&quot; (score of 100 [100-mm scale]). in weeks 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes to a patient's usual medical treatment for fibromyalgia</measure>
    <time_frame>4 weeks</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes to a patient's usual medical treatment for fibromyalgia</measure>
    <time_frame>8 weeks</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes to a patient's usual medical treatment for fibromyalgia</measure>
    <time_frame>12 weeks</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment adherence rate</measure>
    <time_frame>4 weeks</time_frame>
    <description>Treatment adherence rate using the returned capsules, in weeks 4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment adherence rate</measure>
    <time_frame>8 weeks</time_frame>
    <description>Treatment adherence rate using the returned capsules, in weeks 8</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment adherence rate</measure>
    <time_frame>12 weeks</time_frame>
    <description>Treatment adherence rate using the returned capsules, in weeks 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>4 weeks</time_frame>
    <description>Numbre od adverse effects reported, 4 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>8 weeks</time_frame>
    <description>Numbre od adverse effects reported, 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>12 weeks</time_frame>
    <description>Numbre od adverse effects reported, 12 weeks</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>Probiotic group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A multi-strain probiotic</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Identical placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic</intervention_name>
    <description>Probiotic mixture with maltodextrin as a carrier.</description>
    <arm_group_label>Probiotic group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo comparator with maltodextrin as a carrier.</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 20 - 65 years.&#xD;
&#xD;
          2. Signature of informed consent by the patient.&#xD;
&#xD;
          3. Patients diagnosed according to the 2010 American College of Rheumatology (ACR)&#xD;
             diagnostic criteria for fibromyalgia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        11. Women who are pregnant, breastfeeding or who do not commit to using an effective method&#xD;
        of contraception during the course of the study.&#xD;
&#xD;
        2. Known allergy to any of the components of the study product or the placebo. 3.&#xD;
        Consumption of antibiotics in the 2 weeks prior to the start of the study. 4. Consumption&#xD;
        of probiotics in the 2 months prior to the start of the study. 5. Evidence of&#xD;
        neuropsychiatric disorders including: Parkinson's disease, psychotic disorder, bipolar&#xD;
        depression 6. Regular consumption of alcohol in excess of 45 g ethanol/day in the year&#xD;
        prior to study inclusion.&#xD;
&#xD;
        7. Any concurrent malignant pathology known at the time of inclusion in the study or&#xD;
        serious metabolic, cardiovascular, renal, hepatic or gastrointestinal diseases which may&#xD;
        lead to non-completion of the study according to the investigator's criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>María Empar Chenoll, PhD</last_name>
    <phone>+34 673 53 53 44</phone>
    <email>maria.chenoll@adm.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Universitario de Vinalopó</name>
      <address>
        <city>Elche</city>
        <state>Alicante</state>
        <zip>03293</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Victoria Soto Borrás</last_name>
    </contact>
    <investigator>
      <last_name>Maria Victoria Soto Borrás, Dra.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Judith Torres Cañete, Dra.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Antonio Mas Mas, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sandra Rufo Carmona, Dra.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Probiotic</keyword>
  <keyword>Fibromyalgia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04435886
org study id: FIBRO.PROB
nct id: NCT04435886
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 12-week randomized, double-blind, parallel-group, placebo-controlled study
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Double-blind
measure: Score on the Fibromyalgia Impact Questionnaire (FIQ)
time frame: 4-week
description: Score on the Fibromyalgia Impact Questionnaire (FIQ) in weeks 4
measure: Score on the Fibromyalgia Impact Questionnaire (FIQ)
time frame: 8-week
description: 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
measure: Score on the Fibromyalgia Impact Questionnaire (FIQ)
time frame: 12-week
description: 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.
measure: Score on the Hospital Anxiety and Depression Scale (HAD)
time frame: 4 weeks
description: 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
measure: Score on the Hospital Anxiety and Depression Scale (HAD)
time frame: 8 weeks
description: 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
measure: Score on the Hospital Anxiety and Depression Scale (HAD)
time frame: 12 weeks
description: 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.
measure: Visual Analogical Pain Scale (VAS) Score
time frame: 12 weeks
description: 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
measure: Changes to a patient's usual medical treatment for fibromyalgia
time frame: 4 weeks
description: 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)
measure: Changes to a patient's usual medical treatment for fibromyalgia
time frame: 8 weeks
description: 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)
measure: Changes to a patient's usual medical treatment for fibromyalgia
time frame: 12 weeks
description: 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)
measure: Treatment adherence rate
time frame: 4 weeks
description: Treatment adherence rate using the returned capsules, in weeks 4
measure: Treatment adherence rate
time frame: 8 weeks
description: Treatment adherence rate using the returned capsules, in weeks 8
measure: Treatment adherence rate
time frame: 12 weeks
description: Treatment adherence rate using the returned capsules, in weeks 12
measure: Number of adverse events
time frame: 4 weeks
description: Numbre od adverse effects reported, 4 weeks
measure: Number of adverse events
time frame: 8 weeks
description: Numbre od adverse effects reported, 8 weeks
measure: Number of adverse events
time frame: 12 weeks
description: Numbre od adverse effects reported, 12 weeks
arm group label: Probiotic group
arm group type: Experimental
description: A multi-strain probiotic
arm group label: Placebo group
arm group type: Placebo Comparator
description: Identical placebo
intervention type: Dietary Supplement
intervention name: Probiotic
description: Probiotic mixture with maltodextrin as a carrier.
arm group label: Probiotic group
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo comparator with maltodextrin as a carrier.
arm group label: Placebo group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: María Empar Chenoll, PhD
phone: +34 673 53 53 44
email: maria.chenoll@adm.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Spain
responsible party type: Sponsor
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
sharing ipd: No