N/A
N=110
Probiotic VSL#3 for the Treatment of Gastrointestinal Symptoms Associated to Fibromyalgia
Fibromyalgia · Gastrointestinal Disease
Bottom Line
View on ClinicalTrials.gov: NCT04256785 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: 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 — -6.5; -5.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- VSL#3 (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Elena Pita Calandre
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
-6.5; -5.4 | — |
| SECONDARY Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Fibromyalgia Impact Questionnaire Revised (FIQR) |
-7.2; -12.5 | — |
| SECONDARY Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Insomnia Severity Inventory (ISI) |
-1.7; -1.2 | — |
| SECONDARY Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Patient Health Questionnaire (PHQ-9) |
-2.2; -2.5 | — |
| SECONDARY Change, From Baseline to Endpoint (12 Weeks) in the Short-Form Health Survey SF-36 PCS |
4.5; 2.2 | — |
| SECONDARY Change, From Baseline to Endpoint (12 Weeks) in the Short-Form Health Survey SF-36 MCS |
0.8; 1.9 | — |
| SECONDARY Number of Patients Considered as Responders to Treatment |
27; 22 | — |
| 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 |
2.0; 1.7 | — |
| 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 |
1.0; 3.4 | — |
| 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 |
1.3; 4.1 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04256785). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.