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Adjunctive Use of Saccharomyces boulardii versus Bismuth Subsalicylate in the Management of Non-Clostridioides difficile Nosocomial Diarrhea in Severely Ill Patients: A Three-Arm Randomized Controlled Trial

Adjunctive Use of Saccharomyces boulardii versus Bismuth Subsalicylate in the Management of Non-Clostridioides difficile Nosocomial Diarrhea in Severely Ill Patients: A Three-Arm Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250904004
Enrollment
72
Registered
2025-09-04
Start date
2016-08-10
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Non-Clostridioides difficile infection nosocomial diarrhea in hospitalized adult patients Nosocomial diarrhea Antibiotic-associated diarrhea Probiotics Saccharomyces boulardii Bismuth subsalicylate

Interventions

Saccharomyces boulardii (Bioflor) 250 mg capsule orally twice daily for 5 days (500 mg/day).,Bismuth subsalicylate (Gastrobismol-L) 1048 mg tablet orally twice daily for 5 days (2.1 g/day).,Standard c
discretion without adjunctive intervention.
Saccharomyces boulardii,Bismuth subsalicylate,Standard care

Sponsors

Faculty of Medicine Siriraj Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adults patients admitted to internal medicine wards or intensive care units. 2. Development of diarrhea during hospitalization defined as at least 3 or more episodes of unformed stools within 24 hours or at least 1 or more episode of mucous bloody stool within 24 hours. 3. Onset of diarrhea occurred after hospital admission for more than 72 hours. 4. Negative stool test for PCR for Clostridioides difficile toxin. 5. No prior history of chronic diarrhea before hospitalization.

Exclusion criteria

Exclusion criteria: 1. Hemodynamic instability. 2. History of bowel resection resulting in short bowel syndrome. 3. Absolute neutrophil count (ANC) less than 1000 cells/mm3. 4. Ongoing chemotherapy session. 5. HIV infection with CD4 count less than 200 cells/mm3. 6. Known allergy or intolerance to probiotics, bismuth or salicylates. 7. Refusal to participate in the study or withdrawal of consent. 8. Patients with nil per os (NPO) status.

Design outcomes

Primary

MeasureTime frame
Stool weight At end of intervention (day 5) Weighing stool subtract with its container weight.,Stool frequency At end of intervention (day 5) Number of bowel movements per 24 hours,Stool consistency At end of intervention (day 5) Bristol Stool Form Scale

Secondary

MeasureTime frame
Nosocomial diarrhea incidence 12 months Number of hospitalized patients with nosocomial diarrhea,Clinical course of nosocomial diarrhea 7 days Onset of diarrhea, duration of diarrhea, total diarrhea day,Risk factors of nosocomial diarrhea 7 days Patient's factors contributed to diarrhea

Countries

Thailand

Contacts

Public ContactMonthira Maneerattanaporn

Faculty of Medicine Siriraj Hospital, Mahidol University

monthira.man@mahidol.ac.th024197281

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026