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Completed

NCT Number: NCT00589771

Saccharomyces Boulardii in Irritable Bowel Syndrome

Various studies have been conducted in past using different strains of probiotics in evaluating IBS symptoms. The results are by no means consistent and the overall impact of probiotics in IBS remains unclear. However, recently O'Mahony L et al have shown that Bifidobacterium infantis 35624 alleviates symptoms in IBS; this symptomatic response was associated with normalization of the ratio of an anti-inflammatory to a proinflammatory cytokine (IL-10/IL-12 ratio), suggesting an immune-modulating role for this organism, in this disorder.Saccharomyces boulardii is a probiotic yeast that has been successfully used for the antibiotic induced diarrhea, prevent relapse of Clostridium difficile and Crohn's disease. It ameliorates intestinal injury and inflammation caused by a wide variety of enteric pathogens.We therefore plan a Double-blind, randomized, placebo-controlled study to assess the effects of Saccharomyces boulardii in improving symptomatology of diarrhea predominant IBS and its effect on quality of life. We also plan to assess the changes in the relative production of anti-inflammatory interleukin (IL)-10 to proinflammatory cytokines (IL-12, IL-8 and TNFα).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diarrhea-predominant IBS satisfying ROME III criteria.
  • Adults aged 18-70

Exclusion criteria

  • Pregnant and lactating females
  • Inflammatory bowel disease and other systemic disease
  • Patients on anti-diarrheal and antibiotics drugs
  • Patients with any ongoing infection
  • Not willing to participate
  • Allergy to any of Saccharomyces boulardii components
  • Central venous catheter carriers
  • Other probiotics e.g., Lactobacillus and Bifidobacterium

Treatment and study plan

Saccharomyces boulardii

Drug
  • Saccharomyces boulardii one capsule 250mg TDS for 6 weeks
  • Ispaghula husk 1 Tsf daily after dinner for six weeks

Other names: Enflor

Placebo

Drug
  • Cap Placebo TDS for six weeks
  • Ispaghula husk 1 Tsf daily after dinner for six weeks

Primary outcomes

  1. Assess the efficacy of Saccharomyces boulardii in reducing clinical symptoms, improving cytokines levels and histology features

    Time frame: 6 weeks

Secondary outcomes

  1. Assess the efficacy of Saccharomyces boulardii in improving quality of life and safety of the drug

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Collaborators

  • Biocodex

Registry information

Official study title

Clinical and Cytokine Response to Saccharomyces Boulardii Therapy in Diarrhea Dominant Irritable Bowel Syndrome

Acronym: SB-IBS

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 10, 2008
Registry last updated
Oct 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.