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Long-term Effects of Saccharomyces boulardii on Efficacy and Gut Microbiota in IBS-D: A Multicenter, Interventional, Single-Arm Clinical Trial

Long-term Effects of Saccharomyces boulardii on Efficacy and Gut Microbiota in IBS-D: A Multicenter, Interventional, Single-Arm Clinical Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115213
Enrollment
Unknown
Registered
2025-12-23
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Diarrhea-predominant irritable bowel syndrome

Interventions

Saccharomyces boulardii intervention group:Enterol (Saccharomyces boulardii powder): Manufacturer: BIOCODEX (France) 500mg twice a day, taken for four weeks.

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients aged 18 years or older and below 65 years diagnosed with IBS according to the Rome IV criteria. 2. Underwent colonoscopy at a tertiary hospital within 2 years prior to screening, with the examination report retained. 3. Able to comprehend and accept the study protocol, and voluntarily provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant individuals or those unable to practice effective contraception during the study period. 2. Require long-term use of immunosuppressants, glucocorticoids, opioids, antidepressants, or anxiolytics; or use of alcohol, illicit drugs, or other medications that could potentially interfere with the study. 3. Previous definitive diagnosis of organic gastrointestinal diseases, such as inflammatory bowel disease, intestinal tuberculosis, intestinal polyps (polyps < 0.5 cm may still be included), intestinal diverticula, intestinal tumors, etc.; or current coexisting conditions such as peptic ulcer or infectious diarrhea. 4. Systemic diseases that may affect gastrointestinal function, such as hyperthyroidism, diabetes, myasthenia gravis, etc. 5. Previous definitive diagnosis of diseases with symptoms similar to IBS, such as eosinophilic gastroenteritis, microscopic colitis (including collagenous colitis and lymphocytic colitis), lactose intolerance, or malabsorption syndrome. 6. History of gastrointestinal surgery (except appendectomy and intestinal polypectomy), such as cholecystectomy. 7. Presence of severe psychiatric disorders or language barriers, preventing adequate understanding of the study and provision of informed consent. 8. Any other condition considered by the investigator to make the subject unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Gut microbiota;

Secondary

MeasureTime frame
Response rate to treatment for IBS-D;

Countries

China

Contacts

Public ContactXiaohua Hou

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

houxh@hust.edu.cn+86 130 3514 3646

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026