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Probiotic VSL#3 for the Treatment of Gastrointestinal Symptoms Associated to Fibromyalgia

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04256785
Recruitment Status : Completed
First Posted : February 5, 2020
Results First Posted : August 2, 2021
Last Update Posted : August 2, 2021
Sponsor:
Collaborators:
Actial Farmaceutica S.r.l.
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Elena Pita Calandre, Universidad de Granada

Brief Summary:
The study evaluated the efficacy and tolerability of probiotic VSL#3 for the treatment of gastrointestinal symptoms in patients with fibromyalgia; 50% of the participants received probiotic and the remaining 50% received matching placebo in a double-blind, randomized design.The treatment was administered during a 12-week period and the participants were followed for an additional 12-week period in order to follow the evolution after treatment.

Condition or disease Intervention/treatment Phase
Fibromyalgia Gastrointestinal Disease Dietary Supplement: VSL#3 Dietary Supplement: Placebo Not Applicable

Detailed Description:
Many patients with fibromyalgia experience associated gastrointestinal symptomatology such as abdominal pain, abdominal bloating, meteorism, diarrhea and/or constipation. To date there is not any specific treatment for these symptoms that markedly impair the quality of life of these subjects. This trial intended to investigate if the addition of a polymicrobial probiotic product, which has shown efficacy in patients with irritable bowel syndrome, was also be useful to ameliorate the gastrointestinal symptomatology of patients with fibromyalgia.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Tolerability of the Probiotic VSL#3 for the Treatment of Patients With Fibromyalgia and Associated Gastrointestinal Symptomatology: a Randomized, Double-blind Clinical Trial
Actual Study Start Date : May 11, 2018
Actual Primary Completion Date : May 31, 2020
Actual Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: VSL#3
probiotic VSL#3, 2 sachets b.i.d for 3 months
Dietary Supplement: VSL#3
sachets containing probiotic

Placebo Comparator: placebo
matched placebo, 2 sachets b.i.d for 3 months
Dietary Supplement: Placebo
sachets containing placebo




Primary Outcome Measures :
  1. Change, From Baseline to Endpoint (12 Weeks) in the Composite Score of Abdominal Pain, Abdominal Bloating and Metheorism Each One Measured in a 0-10 Visual Analog Scale [ Time Frame: baseline and twelve weeks after treatment ]
    Visual analogue scales are frequently used to evaluate subjective symptoms; they range from 0 (no symptom at all) to 10 (worst possible intensity of the symptom) points. In the present case the three most frequent abdominal symptoms reported by patients with fibromyalgia have been selected to compose the primary outcome variable. Total symptoms range was 0 to 30 points. Change = (week 12 score - baseline score)


Secondary Outcome Measures :
  1. Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Fibromyalgia Impact Questionnaire Revised (FIQR) [ Time Frame: baseline and twelve weeks after treatment ]
    The FIQR is a self-reported, validated questionnaire that evaluates the severity of fibromyalgia symptomatology in a scale ranging from 0 to 100 points; the higher the score, the worse the severity of the disease. Change = (week 12 score - baseline score)

  2. Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Insomnia Severity Inventory (ISI) [ Time Frame: baseline and twelve weeks after treatment ]
    The ISI is a self-reported, validated questionnaire that measures the severity of sleep disturbances in a scale ranging from 0 to 28 points: higher scores indicate more severe sleep disturbance

  3. Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Patient Health Questionnaire (PHQ-9) [ Time Frame: baseline and twelve weeks after treatment ]
    PHQ-9 is a self-reported, validated questionnaire that measures the severity of depression in a scale ranging from 0 to 27 points; higher scores indicate more severe depression. Change = (week 12 score - baseline score)

  4. Change, From Baseline to Endpoint (12 Weeks) in the Short-Form Health Survey SF-36 PCS [ Time Frame: baseline and twelve weeks after treatment ]
    The SF-36 is a self-reported, validated questionnaire evaluating the general health quality in a scale ranging from 0 to 100 points; it evaluates 8 heath domains that yield two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Higher scores indicate better general health quality. Change = (week 12 score - baseline score).

  5. Change, From Baseline to Endpoint (12 Weeks) in the Short-Form Health Survey SF-36 MCS [ Time Frame: baseline and 12 weeks after treatment ]
    The SF-36 is a self-reported, validated questionnaire evaluating the general health quality in a scale ranging from 0 to 100 points; it evaluates 8 heath domains that yield two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Higher scores indicate better general health quality. Change = (week 12 score - baseline score).

  6. Number of Patients Considered as Responders to Treatment [ Time Frame: Baseline and 12 weeks after treatment ]
    Patients that showed at least a a 30% reduction in the score of the primary variable, i.e. the composite ccore of abdominal pain, abdominal bloating and metheorism each one measured in a 0-10 Visual Analog Scale, were considered as responders to treatment.

  7. Change From Week 12 to Week 16 (Follow-up Period) in the Composite Score of Abdominal Pain, Bloating and Metheorism Among Responders After Discontinuing the Study Treatment [ Time Frame: Week 12 to week 16 ]
    Visual analogue scales are frequently used to evaluate subjective symptoms; they range from 0 (no symptom at all) to 10 (worst possible intensity of the symptom) points. In the present case the three most frequent abdominal symptoms reported by patients with fibromyalgia have been selected to compose the primary outcome variable. Total symptoms range was 0 to 30 points. Change = (week 16 score - week 12 score)

  8. Change From Week 12 to Week 20 (Follow-up Period) in the Composite Score of Abdominal Pain, Bloating and Metheorism Among Responders After Discontinuing the Study Treatment [ Time Frame: Week 12 to week 20 ]
    Visual analogue scales are frequently used to evaluate subjective symptoms; they range from 0 (no symptom at all) to 10 (worst possible intensity of the symptom) points. In the present case the three most frequent abdominal symptoms reported by patients with fibromyalgia have been selected to compose the primary outcome variable. Total symptoms range was 0 to 30 points. Change = (week 20 score - week 12 score)

  9. Change From Week 12 to Week 24 (Follow-up Period) in the Composite Score of Abdominal Pain, Bloating and Metheorism Among Responders After Discontinuing the Study Treatment [ Time Frame: Week 12 to week 24 ]
    Visual analogue scales are frequently used to evaluate subjective symptoms; they range from 0 (no symptom at all) to 10 (worst possible intensity of the symptom) points. In the present case the three most frequent abdominal symptoms reported by patients with fibromyalgia have been selected to compose the primary outcome variable. Total symptoms range was 0 to 30 points. Change = (week 24 score - week 12 score)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosed of fibromyalagia
  • experiencing at least 3 chronic gastrointestinal symptoms
  • signed informed consent to participate
  • accept to not change previously prescribed treatment during study duration

Exclusion Criteria:

  • mental illness excepting depression
  • severe organic disease
  • additional gastrointestinal disease excepting irritable bowel syndrome
  • pregnancy
  • breastfeeding

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): NCT04256785


Locations
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Spain
Instituto de Neurociencias "Federico Oloriz"
Granada, Spain, 18012
Sponsors and Collaborators
Elena Pita Calandre
Actial Farmaceutica S.r.l.
Ferring Pharmaceuticals
Investigators
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Principal Investigator: Elena P. Calandre, M.D. Universidad de Granada
  Study Documents (Full-Text)

Documents provided by Elena Pita Calandre, Universidad de Granada:
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Responsible Party: Elena Pita Calandre, professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT04256785    
Other Study ID Numbers: FMS-VSL3-19
First Posted: February 5, 2020    Key Record Dates
Results First Posted: August 2, 2021
Last Update Posted: August 2, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcomes will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: One year after study completion
Access Criteria: Data access requests will be reviewed by study sponsor and P.I.

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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 Elena Pita Calandre, Universidad de Granada:
probiotic
efficacy
tolerability
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Gastrointestinal Diseases
Digestive System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases