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The effect of Saccharomyces boulardii on acute gastroenteritis in adults: a randomized controlled trial

The effect of Saccharomyces boulardii on acute gastroenteritis in adults: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050478
Enrollment
Unknown
Registered
2021-08-27
Start date
2021-12-31
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

Acute gastroenteritis in adults

Interventions

Intervention group:Routine treatment and Saccharomyces boulardii 500mg/d
Control group:Conventional treatment and placebo 500mg/d

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The patient agrees to participate in the trial and signs the informed consent; 2. The patient has >= 3 stool samples within 24 hours; 3. The duration of the patient's diarrhea is less than 72 hours; 4. Aged >=18 years.

Exclusion criteria

Exclusion criteria: 1. There is indwelling vascular access (risk of bacteremia); 2. Being receiving immunosuppressive therapy or a known history of immunodeficiency (risk of bacteremia); 3. Oral or gastrointestinal surgery in the first 7 days (risk of bacteremia); 4. Critically ill patients (risk of bacteremia); 5. Blood in the stool in the past 72 hours, potentially serious chronic gastrointestinal problems or inflammatory bowel disease: excluding constipation, gastroesophageal reflux or chronic pain; 6. Patients during lactation or pregnancy; 7. Symptoms are caused by excessive drinking or taking drugs; 8. Use of probiotics, prebiotics or synbiotics in the first 4 weeks: but those who eat food containing the above ingredients are not excluded; 9. Received antibiotic treatment within the first 4 weeks; 10. Allergies to Saccharomyces boulardii or placebo ingredients (maltodextrin); 11. Previously included in this trial or participated in other trials at the same time; 12. No daily follow-up by phone or internet, or recent travel/business trip plans.

Design outcomes

Primary

MeasureTime frame
Duration of diarrhea;Total effective rate;

Secondary

MeasureTime frame
Number of diarrhea;Number of vomiting;Vomiting duration;Abdominal pain score;Duration of abdominal pain;Modified Vesikari Score (MVS);Peripheral blood mononuclear cells;Inflammatory factors;Adverse reactions;Intestinal flora;

Countries

China

Contacts

Public ContactTang Yuhan

Tongji Medical College, Huazhong University of Science and Technology

2015220157@hust.edu.cn+86 150712693339

Outcome results

None listed

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