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| Name | Class |
|---|---|
| Actial Farmaceutica S.r.l. | INDUSTRY |
| Ferring Pharmaceuticals | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VSL#3 | Experimental | probiotic VSL#3, 2 sachets b.i.d for 3 months |
|
| placebo | Placebo Comparator | matched placebo, 2 sachets b.i.d for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VSL#3 | Dietary Supplement | sachets containing probiotic |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) | baseline and twelve weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Fibromyalgia Impact Questionnaire Revised (FIQR) | 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) | baseline and twelve weeks after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena P. Calandre, M.D. | Universidad de Granada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Neurociencias "Federico Oloriz" | Granada | 18012 | Spain |
De-identified individual participant data for all primary and secondary outcomes will be made available
One year after study completion
Data access requests will be reviewed by study sponsor and P.I.
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| ID | Title | Description |
|---|---|---|
| FG000 | VSL#3 | probiotic VSL#3, 2 sachets b.i.d for 3 months VSL#3: sachets containing probiotic |
| FG001 | Placebo | matched placebo, 2 sachets b.i.d for 3 months Placebo: sachets containing placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VSL#3 | probiotic VSL#3, 2 sachets b.i.d for 3 months VSL#3: sachets containing probiotic |
| BG001 | Placebo | matched placebo, 2 sachets b.i.d for 3 months Placebo: sachets containing placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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) | Intent to Treat Population (all patients with at least a post-baseline evaluation) | Posted | Mean | Standard Deviation | score on a scale | baseline and twelve weeks after treatment |
|
12 weeks
Adverse events were collected at each visit during the 12 weeks treatment period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VSL#3 | probiotic VSL#3, 2 sachets b.i.d for 3 months VSL#3: sachets containing probiotic |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal distension | Gastrointestinal disorders | Non-systematic Assessment |
The high number of patients in both groups that prematurely withdrew from the study for reasons unrelated with treatment tolerability and/or efficacy, hinders the trials capacity to accurately evaluate efficacy of the studied probiotic.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elena Pita Calandre | Universidad de Granada | +34 958246291 | epita@ugr.es |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 2, 2020 | May 15, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| Dietary Supplement |
sachets containing placebo |
|
| Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Insomnia Severity Inventory (ISI) | 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 | baseline and twelve weeks after treatment |
| Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Patient Health Questionnaire (PHQ-9) | 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) | baseline and twelve weeks after treatment |
| Change, From Baseline to Endpoint (12 Weeks) in the Short-Form Health Survey SF-36 PCS | 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). | baseline and twelve weeks after treatment |
| Change, From Baseline to Endpoint (12 Weeks) in the Short-Form Health Survey SF-36 MCS | 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). | baseline and 12 weeks after treatment |
| Number of Patients Considered as Responders to 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. | Baseline and 12 weeks after treatment |
| 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 | 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) | Week 12 to week 16 |
| 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 | 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) | Week 12 to week 20 |
| 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 | 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) | Week 12 to week 24 |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Surgery or quarantined due to Covid-19 |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Weight (Kg) | Mean | Standard Deviation | kgs |
|
| Fibromyalgia diagnosis - Widespread Pain Index (WPI) total score | The WPI assesses presence of pain in 19 designated body locations over the past 7-days. Each location is equal to a score of 1. Items are summed to yield a total score, with higher scores indicating greater widespread pain. | Mean | Standard Deviation | scores on a scale |
|
| Fibromyalgia diagnosis - Symptom Severity Score | The SSS is a scale that evaluates the presence and severity of associated symptoms, excluding pain, in patients with fibromyalgia. The SSS total score is calculated by summing the 0-3 scores of somatic symptoms, waking unrefreshed, cognition, and fatigue into a 0-12 scale. Higher scores indicate more associated symptoms of higher severity. | Mean | Standard Deviation | scores on a scale |
|
| Fibromyalgia diagnosis - Fibromyalgia Score | The FS score is the sum of WPI and SSS. The total score ranges from 0 to 31 points. Higher scores indicate higher fibromyalgia severity scores. | Mean | Standard Deviation | scores on a scale |
|
| OG001 | Placebo | matched placebo, 2 sachets b.i.d for 3 months Placebo: sachets containing placebo 56 subjects |
|
|
| Secondary | Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Fibromyalgia Impact Questionnaire Revised (FIQR) | 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) | Intent to Treat Population (all patients with at least a post-baseline evaluation) | Posted | Mean | Standard Deviation | score on a scale | baseline and twelve weeks after treatment |
|
|
|
| Secondary | Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Insomnia Severity Inventory (ISI) | 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 | Intent to Treat Population (all patients with at least a post-baseline evaluation) | Posted | Mean | Standard Deviation | score on a scale | baseline and twelve weeks after treatment |
|
|
|
| Secondary | Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Patient Health Questionnaire (PHQ-9) | 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) | Intent to Treat Population (all patients with at least a post-baseline evaluation) | Posted | Mean | Standard Deviation | score on a scale | baseline and twelve weeks after treatment |
|
|
|
| Secondary | Change, From Baseline to Endpoint (12 Weeks) in the Short-Form Health Survey SF-36 PCS | 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). | Intent to Treat Population (all patients with at least a post-baseline evaluation) | Posted | Mean | Standard Deviation | score on a scale | baseline and twelve weeks after treatment |
|
|
|
| Secondary | Change, From Baseline to Endpoint (12 Weeks) in the Short-Form Health Survey SF-36 MCS | 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). | Intent to Treat Population (all patients with at least a post-baseline evaluation) | Posted | Mean | Standard Deviation | score on a scale | baseline and 12 weeks after treatment |
|
|
|
| Secondary | Number of Patients Considered as Responders to 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. | Intent to Treat Population (all patients with at least a post-baseline evaluation) | Posted | Number | participants | Baseline and 12 weeks after treatment |
|
|
|
| Secondary | 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 | 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) | Patients considered as responders to treatment | Posted | Mean | Standard Deviation | units on a scale | Week 12 to week 16 |
|
|
|
| Secondary | 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 | 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) | Patients considered as responders to treatment | Posted | Mean | Standard Deviation | units on a scale | Week 12 to week 20 |
|
|
|
| Secondary | 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 | 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) | Patients considered as responders to treatment | Posted | Mean | Standard Deviation | units on a scale | Week 12 to week 24 |
|
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| 20 |
| 54 |
| EG001 | Placebo | matched placebo, 2 sachets b.i.d for 3 months Placebo: sachets containing placebo | 0 | 56 | 0 | 56 | 19 | 56 |
| flatulence | Gastrointestinal disorders | Non-systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Disease worsening | General disorders | Non-systematic Assessment |
|
| Dispepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Upper abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Swelling | General disorders | Non-systematic Assessment |
|
| Influenza | Infections and infestations | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D009422 |
| Nervous System Diseases |
| D004066 | Digestive System Diseases |