Introduction
Methods
1. Study design
2. Patients and methods
3. Randomization and blinding
4. Statistical analysis
Results
Table 1.
Crying frequency | Probiotics | Control | Test value | P value |
---|---|---|---|---|
Day 0 | - | - | ||
 Increased | 15 (100) | 16 (100) | ||
 Decreased | - | |||
 Unchanged | - | |||
Day 7 | 7.315†| 0.030 | ||
 Increased | 0 (0) | 5 (31.2) | ||
 Decreased | 8 (53.3) | 3 (18.8) | ||
 Unchanged | 7 (46.7) | 8 (50.0) | ||
Day 15 | 14.895†| 0.000 | ||
 Increased | 0 (0) | 4 (25.0) | ||
 Decreased | 12 (80.0) | 2 (12.5) | ||
 Unchanged | 3 (20.0) | 10 (62.5) | ||
Sum | 15 (100) | 16 (100) |
†Chi-square analysis (increase, expressed as ≥50% increase in mean daily crying time [intensity greater than 5/10] expressed as duration; decreased, expressed as ≥50% reduction in mean daily crying time [intensity less than 5/10] expressed as duration; unchanged, average daily crying time [intensity greater than 5/10] unchanged compared to the previous day expressed as duration).
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Fig. 2.Alpha and beta diversity measurements of the infant fecal microbiome in the probiotic (PG) and control groups (CG). (A) Pairwise comparisons of alpha diversity indices (Shannon, Simpson) were performed between visits to examine specific comparisons of interest in the CG (green) and PG (blue). Boxplots show the first and second quartiles and the whiskers extend out to the 1.5×interquartile range of the upper and lower limits. (B) Diversity index comparisons with microbial stool samples of infants with infantile colic. Principal component analysis profiles of bacterial composition at the operational taxonomic unit level of infants in the PG and CG to evaluate beta variations between stool samples; distance algorithm: weighted unifrac distance is used. Ellipses (yellow and blue) represent the standard deviation of all points within a cohort. Comparison of community profiles at the amplicon sequence variant level between the PG and CG on days 0 and 15: CG (blue) and PG (yellow). Principal component analysis (PCA) was performed (P=0.001). |