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

NCT04256785 | Completed Results

• 1 other identifier: FMS-VSL3-19
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Gastrointestinal Disease

Keywords

probiotic; efficacy; tolerability

Outcome Measures

Primary Outcomes (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

  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

Secondary Outcomes (9)

• Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Fibromyalgia Impact Questionnaire Revised (FIQR)

  baseline and twelve weeks after treatment

• Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Insomnia Severity Inventory (ISI)

  baseline and twelve weeks after treatment

• Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Patient Health Questionnaire (PHQ-9)

  baseline and twelve weeks after treatment

• Change, From Baseline to Endpoint (12 Weeks) in the Short-Form Health Survey SF-36 PCS

  baseline and twelve weeks after treatment

• Change, From Baseline to Endpoint (12 Weeks) in the Short-Form Health Survey SF-36 MCS

  baseline and 12 weeks after treatment

Study Arms (2)

VSL#3

EXPERIMENTAL

probiotic VSL#3, 2 sachets b.i.d for 3 months

Dietary Supplement: VSL#3

placebo

PLACEBO COMPARATOR

matched placebo, 2 sachets b.i.d for 3 months

Dietary Supplement: Placebo

Interventions

VSL#3 DIETARY_SUPPLEMENT

sachets containing probiotic

VSL#3

Placebo DIETARY_SUPPLEMENT

sachets containing placebo

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Elena Pita Calandre: lead
• Actial Farmaceutica S.r.l.: collaborator
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

Instituto de Neurociencias "Federico Oloriz"

Granada, 18012, Spain

Location

MeSH Terms

Conditions

Fibromyalgia; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Digestive System Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Elena Pita Calandre
• Organization: Universidad de Granada

epita@ugr.es

+34 958246291

Study Officials

• Elena P. Calandre, M.D.

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 2, 2020
• First Posted: February 5, 2020
• Study Start: May 11, 2018
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: August 2, 2021
• Results First Posted: August 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: One year after study completion
• Access Criteria: Data access requests will be reviewed by study sponsor and P.I.

Locations

ES (1)