FibromyalgiaFIBROPROBNCT04435886
Use of a Probiotic in the Treatment of Fibromyalgia (FIBROPROB)
A study testing Probiotic in people with Fibromyalgia, run by Biopolis S.L. at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 2 Mar 2020to 2 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Vinalopó
Elche, Alicante, 03293
Maria Victoria Soto Borrás
Maria Victoria Soto Borrás, Dra.
About this study
Official title: A 12-weeks Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of a Probiotic in the Treatment of Fibromyalgia
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.
- Conditions
- Fibromyalgia
- Being tested
- Probiotic, Placebo
- Keywords
- Probiotic, Fibromyalgia
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Probiotic mixture with maltodextrin as a carrier.
PlaceboDietary supplement
Placebo comparator with maltodextrin as a carrier.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | A multi-strain probiotic Receives: Dietary Supplement: Probiotic |
| Placebo group | Placebo comparator | Identical placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on the Fibromyalgia Impact Questionnaire (FIQ)
Score on the Fibromyalgia Impact Questionnaire (FIQ) in weeks 4
Measured: 4-week
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
Measured: 8-week
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.
Measured: 12-week
Secondary outcomes (13)
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
Measured: 4 weeks
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
Measured: 8 weeks
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.
Measured: 12 weeks
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
Measured: 12 weeks
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)
Measured: 4 weeks
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)
Measured: 8 weeks
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)
Measured: 12 weeks
Treatment adherence rate
Treatment adherence rate using the returned capsules, in weeks 4
Measured: 4 weeks
Treatment adherence rate
Treatment adherence rate using the returned capsules, in weeks 8
Measured: 8 weeks
Treatment adherence rate
Treatment adherence rate using the returned capsules, in weeks 12
Measured: 12 weeks
Number of adverse events
Numbre od adverse effects reported, 4 weeks
Measured: 4 weeks
Number of adverse events
Numbre od adverse effects reported, 8 weeks
Measured: 8 weeks
Number of adverse events
Numbre od adverse effects reported, 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start2 Mar 2020
- Primary completion2 Feb 2021 (estimated)
- Study completion2 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 12-week randomized, double-blind, parallel-group, placebo-controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biopolis S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435886
- Sponsor's protocol ID
- FIBRO.PROB
- Acronym
- FIBROPROB
- Status last verified
- Jun 2020
- First submitted
- 15 Jun 2020
- Last updated
- 10 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-weeks Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of a Probiotic in the Treatment of Fibromyalgia
- ClinicalTrials.gov ID
- NCT04435886
- Acronym / sponsor ID
- FIBROPROB / FIBRO.PROB
- Conditions
- Fibromyalgia
- Keywords
- Probiotic, Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Biopolis S.L.Industry (pharma, biotech, devices)
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 2 Feb 2021 (estimated)
- Study completion
- 2 May 2021 (estimated)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 12-week randomized, double-blind, parallel-group, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: ProbioticA multi-strain probiotic |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboIdentical placebo |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticProbiotic mixture with maltodextrin as a carrier. | Dietary supplement | Probiotic group |
| PlaceboPlacebo comparator with maltodextrin as a carrier. | Dietary supplement | Placebo group |
Primary outcome
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.
13 secondary outcomes
Score on the Hospital Anxiety and Depression Scale (HAD)
Time frame: 4 weeks
Score on the Hospital Anxiety and Depression Scale (HAD)
Time frame: 8 weeks
Score on the Hospital Anxiety and Depression Scale (HAD)
Time frame: 12 weeks
Visual Analogical Pain Scale (VAS) Score
Time frame: 12 weeks
Changes to a patient's usual medical treatment for fibromyalgia
Time frame: 4 weeks
Changes to a patient's usual medical treatment for fibromyalgia
Time frame: 8 weeks
Changes to a patient's usual medical treatment for fibromyalgia
Time frame: 12 weeks
Treatment adherence rate
Time frame: 4 weeks
Treatment adherence rate
Time frame: 8 weeks
Treatment adherence rate
Time frame: 12 weeks
Number of adverse events
Time frame: 4 weeks
Number of adverse events
Time frame: 8 weeks
Number of adverse events
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Fibromyalgia, run by Biopolis S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact María Empar Chenoll, PhD (+34 673 53 53 44, maria.chenoll@adm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on the Fibromyalgia Impact Questionnaire (FIQ) (time frame: 4-week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2020.