Table 1.
Characteristics of study participants and disease symptoms at enrollment.
| Characteristic | Saccharomyces boulardiiCNCM I-745 (N = 157) | Bacillus clausiiO/C, SIN, N/R, T (N = 158) |
|---|---|---|
| Gender, n (%) | ||
| Female | 67 (42.7) | 72 (45.6) |
| Age | ||
| Mean ± SD (mo) | 26.8 ± 15.5 | 24.0 ± 14.2 |
| Range (mo) | 6.2-69.9 | 6.0-71.3 |
| Body weight | ||
| Mean ± SD (kg) | 12.8 ± 3.7 | 11.9 ± 3.0 |
| Range (kg) | 10.2-15.1 | 9.7-13.9 |
| Breast-fed since birth, n (%) | 152 (96.8) | 154 (97.5) |
| Any medical history, n (%)* | ||
| Infections and infestations | 7 (4.5) | 10 (6.3) |
| Respiratory disorders | 2 (1.3) | 2 (1.3) |
| Gastrointestinal disorders | 3 (1.9) | 0 |
| Skin conditions | 0 | 3 (1.9) |
| Congenital, familial and genetic disorders | 1 (0.6) | 0 |
| Neoplasms (benign/malignant/unspecified) | 0 | 1 (0.6) |
| Diarrhea severity, n (%)† | ||
| Mild | 153 (97.5) | 150 (94.9) |
| Moderate | 4 (2.5) | 8 (5.1) |
| Severe | 0 | 0 |
| Dehydration, n (%) | ||
| None | 155 (99.4) | 158 (100) |
| Mild | 1 (0.6) | 0 |
| Severe | 0 | 0 |
| Not reported | 1 | 0 |
| Nutritional status, n (%) | ||
| Overweight/obese | 2 (1.3) | 0 (0) |
| Normal | 155 (98.7) | 158 (100) |
| Malnutrition | 0 (0) | 0 (0) |
| History rotavirus vaccination, n (%) | 127 (80.9) | 142 (89.9) |
| Time since rotavirus vaccination, mean ± SD (days) | 581.9 ± 408.7 | 518.5 ± 365.0 |
| Recent history diarrhea in family, n (%) | 30 (19.1) | 28 (17.7) |
| Duration diarrhea prior to Day 1, mean ± SD | 1.9 ± 0.9 | 2.2 ± 1.0 |
| Etiology of diarrhea, n (%)‡ | ||
| Not determined | 114 (72.6) | 122 (77.24) |
| Rotavirus | 13 (8.3) | 11 (6.9) |
| Adenovirus | 7 (4.5) | 10 (6.3) |
| Shigella | 9 (5.7) | 6 (3.8) |
| Campylobacter | 6 (3.8) | 2 (1.3) |
| Salmonella | 4 (2.5) | 2 (1.3) |
| Escherichia coli O:157 | 1 (0.6) | 0 |
% = percentage, n = number of patients, SD = standard deviation.
Any medical conditions include: infections and infestations (bronchitis, rhinitis, bronchiolitis, gastroenteritis, influenza, conjunctivitis, urinary tract infection, viral rash or laryngitis), respiratory disorders (asthma, bronchial disorder, cough), gastrointestinal disorders (gastroesophageal reflux disease or inguinal hernia), skin conditions (dermatitis), congenital, familial and genetic disorders (congenital heart disease), and neoplasms (hemangioma).
Severity measured with Modified Vesikari Score (0–8 mild, 9–10 moderate, >11 severe).
Excluding no stool sample collected (n = 8) and missing data (n = 1).