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Search / Trial NCT04256785

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

Launched by ELENA PITA CALANDRE · Feb 4, 2020

Trial Information

Current as of June 24, 2025

Completed

Keywords

Probiotic Efficacy Tolerability

ClinConnect Summary

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.

Gender

ALL

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

About Elena Pita Calandre

Elena Pita Calandre is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. Leveraging extensive expertise in clinical development and regulatory affairs, she oversees innovative studies aimed at evaluating new therapies and interventions across various therapeutic areas. Her focus on collaboration and ethical standards ensures that trials are conducted with the utmost integrity, prioritizing patient safety and data reliability. With a passion for translating scientific discoveries into practical solutions, Elena Pita Calandre plays a pivotal role in enhancing the landscape of healthcare through rigorous clinical investigation.

Locations

Granada, , Spain

Patients applied

0 patients applied

Trial Officials

Elena P. Calandre, M.D.

Principal Investigator

Universidad de Granada

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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