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Method Article
This protocol evaluates the age-specific clinical efficacy and safety of Saccharomyces boulardii as an adjunct therapy for infectious enteritis, using a randomized controlled trial in pediatric patients and a real-world observational study in adults.
Infectious enteritis remains a significant global health burden, particularly among children under five years of age. Saccharomyces boulardii (S. boulardii), a probiotic yeast, has been widely studied for its role in reducing diarrhea; however, direct comparisons of its effects across age groups remain limited. This study aims to evaluate and compare the efficacy and safety of S. boulardii in pediatric and adult patients with infectious enteritis. A double-blind, randomized, placebo-controlled trial was conducted in 186 children with acute diarrhea, while a retrospective observational study included 270 adult patients. All participants received standard rehydration therapy; the intervention groups additionally received S. boulardii. The primary outcome was diarrhea duration. Secondary outcomes included stool frequency, length of hospital stay, recurrence rate, and adverse events. In pediatric patients, S. boulardii significantly reduced diarrhea duration (2.1 vs. 3.9 days in rotavirus-positive cases), hospital stay (3.2 vs. 4.8 days), and stool frequency (4.2 vs. 6.7 stools/day) compared to placebo (all p < 0.05). In adult patients, S. boulardii was associated with shorter diarrhea duration (2.7 vs. 5.4 days), reduced hospital stay (3.6 vs. 5.2 days), higher symptom resolution rates (77.8% vs. 15.8%), and lower recurrence (8.1% vs. 21.7%; all p < 0.01). Adverse events were mild and comparable between groups. S. boulardii appears to be a safe and effective adjunct therapy for infectious enteritis, with age-related differences in clinical outcomes. S. boulardii appears to be a safe and effective adjunct therapy for infectious enteritis in both pediatric and adult populations. Within each cohort, improvements were observed in clinical outcomes, including diarrhea duration, hospitalization, and recurrence. Observed differences between pediatric and adult cohorts are descriptive and reflect separate analyses conducted under different study designs; therefore, no direct statistical comparisons between age groups were performed.
Infectious enteritis is an inflammatory condition of the small intestine caused by bacterial, viral, or parasitic pathogens and represents a major global health burden affecting both children and adults. Transmission commonly occurs through contaminated food or water and via person-to-person spread, making the disease highly contagious1,2. Children under 5 years of age are disproportionately affected, with infectious enteritis contributing significantly to morbidity and mortality in low- and middle-income countries3,4. According to the World Health Org....
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All procedures involving human participants were conducted in accordance with institutional and national ethical standards. The pediatric randomized controlled trial was approved by the Ethics Committee of Harbin Fourth Hospital, Harbin, China (Approval No.: KY2026-06). Written informed consent was obtained from the parents or legal guardians of all pediatric participants prior to enrolment. The adult retrospective observational cohort study was approved by the Ethics Committee of Harbin Fourth Hospital, Harbin, China (Approval No.: KY2026-06), with informed consent waived due to the study's retrospective nature.
1. Study design a....
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Table 3 summarizes the demographic and clinical baseline characteristics of the pediatric participants (n = 176). The mean age of children receiving S. boulardii was 23.0 ± 12.3 months, compared to 21.2 ± 11.8 months in the placebo group. The sex distribution was comparable between groups (S. boulardii: 47 males/43 females; placebo: 51 males/35 females). Chi-square analysis of sex distribution showed no statistically significant difference (χ2 = 0.63, p = 0.428), confirming t.......
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Importantly, outcomes from pediatric and adult cohorts should not be directly compared. The pediatric study was a randomized controlled trial, whereas the adult cohort was a retrospective, observational cohort. Therefore, any differences observed between cohorts are descriptive and may reflect differences in study design, population characteristics, or underlying disease etiology rather than true comparative treatment effects. The study is presented in a structured protocol format to enhance reproducibility and transpare.......
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The authors declare that they have no financial conflicts of interest.
| Name | Company | Catalog Number | Comments |
|---|---|---|---|
| Computer with statistical software | IBM; R Foundation for Statistical Computing | SPSS v25.0; R v4.3.1 | Licensed statistical software Purpose: Data analysis |
| Econorm | Beijing Hanmi Pharmaceutical Co., Ltd., Beijing | CNCM I-745 | Commercial strains Purpose: NA |
| Electronic medical record system | Hospital information system | Institutional system | Secure digital patient database Purpose: Data extraction (adult cohort) |
| Florastor | Biocodex, France | (S. boulardii CNCM I-745) | Commercial strains Purpose: NA |
| IBM SPSS Statistics version 25.0 | IBM Corp., Armonk, NY, USA | Version 25.0 | Used for statistical analysis, including chi-square tests, odds ratio calculation, and significance testing |
| Intravenous fluid (0.9% sodium chloride) | Baxter Healthcare / Fresenius Kabi | As per supplier | Sterile isotonic saline solution Purpose: Intravenous rehydration |
| Oral rehydration salts (ORS) | World Health Organization formulation | WHO standard ORS sachet | Low-osmolarity ORS (Na + 75 mmol/L) Intravenous rehydration Purpose: Oral rehydration therapy |
| Personal protective equipment (PPE) | 3M / equivalent | Gloves, masks, lab coats | Disposable protective gear Purpose: Biosafety compliance |
| Placebo sachets (maltodextrin) | Beijing Hanmi Pharmaceutical Co., Ltd., Beijing, China. | Custom-prepared | 250 mg per sachet, identical in appearance to active drug Purpose: Control intervention |
| R software version 4.3.1 | R Foundation for Statistical Computing, Vienna, Austria | Version 4.3.1 | Used for statistical analysis, subgroup analysis, and multivariable regression modeling |
| Randomization software | R software / GraphPad Prism | v4.3.1 / v10 | Computer-generated block randomization Purpose: Allocation sequence |
| Rotavirus antigen rapid test kit | Abbott Diagnostics / SD Biosensor | SD BIOLINE Rota/Adeno | Immunochromatographic assay Purpose: Rotavirus detection |
| Saccharomyces boulardii CNCM I-745 sachets | [Beijing Hanmi Pharmaceutical Co., Ltd., Beijing, China. | [Insert catalog/product code] | 250 mg lyophilized probiotic yeast per sachet Purpose: Intervention |
| Stool collection container (sterile) | Thermo Fisher Scientific / equivalent | 120 mL sterile container | Leak-proof, sterile Purpose: Stool sample collection |
| Stool transport container/bag | BD Biosciences / equivalent | Specimen transport kit | Biohazard-labeled, sealed transport Purpose: Sample handling |