Saccharomyces Boulardii in Irritable Bowel Syndrome

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00589771

Acronym

SB-IBS

Enrollment

Registered

2008-01-10

Start date

2010-01-31

Completion date

2011-12-31

Last updated

2012-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhea Dominant Irritable Bowel Syndrome

Keywords

IBS, Saccharomyces boulardii, probiotics, cytokine, histology, Efficacy

Brief summary

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).

Interventions

DRUGSaccharomyces boulardii

1. Saccharomyces boulardii one capsule 250mg TDS for 6 weeks 2. Ispaghula husk 1 Tsf daily after dinner for six weeks

DRUGPlacebo

1. Cap Placebo TDS for six weeks 2. Ispaghula husk 1 Tsf daily after dinner for six weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Diarrhea-predominant IBS satisfying ROME III criteria. 2. Adults aged 18-70

Exclusion criteria

1. Pregnant and lactating females 2. Inflammatory bowel disease and other systemic disease 3. Patients on anti-diarrheal and antibiotics drugs 4. Patients with any ongoing infection 5. Not willing to participate 6. Allergy to any of Saccharomyces boulardii components 7. Central venous catheter carriers 8. Other probiotics e.g., Lactobacillus and Bifidobacterium

Design outcomes

Primary

Measure	Time frame
Assess the efficacy of Saccharomyces boulardii in reducing clinical symptoms, improving cytokines levels and histology features	6 weeks

Secondary

Measure	Time frame
Assess the efficacy of Saccharomyces boulardii in improving quality of life and safety of the drug	6 weeks

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026