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

Primary Purpose

Fibromyalgia

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
Biopolis S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Probiotic, Fibromyalgia

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario de VinalopóRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic group

Placebo group

Arm Description

A multi-strain probiotic

Identical placebo

Outcomes

Primary Outcome Measures

Score on the Fibromyalgia Impact Questionnaire (FIQ)
Score on the Fibromyalgia Impact Questionnaire (FIQ) in weeks 4
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
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.

Secondary Outcome Measures

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
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
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.
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
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)
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)
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)
Treatment adherence rate
Treatment adherence rate using the returned capsules, in weeks 4
Treatment adherence rate
Treatment adherence rate using the returned capsules, in weeks 8
Treatment adherence rate
Treatment adherence rate using the returned capsules, in weeks 12
Number of adverse events
Numbre od adverse effects reported, 4 weeks
Number of adverse events
Numbre od adverse effects reported, 8 weeks
Number of adverse events
Numbre od adverse effects reported, 12 weeks

Full Information

First Posted
June 15, 2020
Last Updated
July 8, 2020
Sponsor
Biopolis S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT04435886
Brief Title
Use of a Probiotic in the Treatment of Fibromyalgia (FIBROPROB)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
February 2, 2021 (Anticipated)
Study Completion Date
May 2, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biopolis S.L.

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Probiotic, Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
12-week randomized, double-blind, parallel-group, placebo-controlled study
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic group
Arm Type
Experimental
Arm Description
A multi-strain probiotic
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Identical placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
Probiotic mixture with maltodextrin as a carrier.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator with maltodextrin as a carrier.
Primary Outcome Measure Information:
Title
Score on the Fibromyalgia Impact Questionnaire (FIQ)
Description
Score on the Fibromyalgia Impact Questionnaire (FIQ) in weeks 4
Time Frame
4-week
Title
Score on the Fibromyalgia Impact Questionnaire (FIQ)
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
Time Frame
8-week
Title
Score on the Fibromyalgia Impact Questionnaire (FIQ)
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.
Time Frame
12-week
Secondary Outcome Measure Information:
Title
Score on the Hospital Anxiety and Depression Scale (HAD)
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
Time Frame
4 weeks
Title
Score on the Hospital Anxiety and Depression Scale (HAD)
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
Time Frame
8 weeks
Title
Score on the Hospital Anxiety and Depression Scale (HAD)
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.
Time Frame
12 weeks
Title
Visual Analogical Pain Scale (VAS) Score
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
Time Frame
12 weeks
Title
Changes to a patient's usual medical treatment for fibromyalgia
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)
Time Frame
4 weeks
Title
Changes to a patient's usual medical treatment for fibromyalgia
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)
Time Frame
8 weeks
Title
Changes to a patient's usual medical treatment for fibromyalgia
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)
Time Frame
12 weeks
Title
Treatment adherence rate
Description
Treatment adherence rate using the returned capsules, in weeks 4
Time Frame
4 weeks
Title
Treatment adherence rate
Description
Treatment adherence rate using the returned capsules, in weeks 8
Time Frame
8 weeks
Title
Treatment adherence rate
Description
Treatment adherence rate using the returned capsules, in weeks 12
Time Frame
12 weeks
Title
Number of adverse events
Description
Numbre od adverse effects reported, 4 weeks
Time Frame
4 weeks
Title
Number of adverse events
Description
Numbre od adverse effects reported, 8 weeks
Time Frame
8 weeks
Title
Number of adverse events
Description
Numbre od adverse effects reported, 12 weeks
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 20 - 65 years. Signature of informed consent by the patient. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
María Empar Chenoll, PhD
Phone
+34 673 53 53 44
Email
maria.chenoll@adm.com
Facility Information:
Facility Name
Hospital Universitario de Vinalopó
City
Elche
State/Province
Alicante
ZIP/Postal Code
03293
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Victoria Soto Borrás
First Name & Middle Initial & Last Name & Degree
Maria Victoria Soto Borrás, Dra.
First Name & Middle Initial & Last Name & Degree
Judith Torres Cañete, Dra.
First Name & Middle Initial & Last Name & Degree
Antonio Mas Mas, Dr.
First Name & Middle Initial & Last Name & Degree
Sandra Rufo Carmona, Dra.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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