Table 1.
Clinical trials included in the meta-analysis
| Study | Type of study | Probiotic strain (dose) | Duration of treatment | Population and type of feeding | Age | Results |
|---|---|---|---|---|---|---|
| Kianifar et al. [28] | A randomized controlled trial | Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium infantis, Lactobacillus bulgaricus and fructooligosaccharide (108 CFU/day) | 30 Days | BF infants | 15–120 Days | Significant improvement of colic symptoms in the probiotics group |
| Pärtty et al. [4] | Doubleblind placebo-controlled intervention trial | LGG (4.5 × 109 CFU/day) | 28 Days | 30 BF and FF infants | 34.8–38 Days | The parents declared about the protective role of probiotics in infantile colic but the results of the evaluation of crying time were not significantly different between placebo and probiotics group |
| Mi et al. [29] | A placebo-controlled observational randomized study | Lactobacillus reuteri DSM 17938 (108 CFU) | 21 Days | 42 BF infants | Less than 4 months | 100% Treatment success in the probiotic group, significant reduction of mean crying time, maternal depression and significant increment of maternal satisfaction. |
| Savino et al. [30] | Randomized clinical trial | Lactobacillus reuteri DSM17938 (1×108 CFU/day) | 28 Days | 50 BF infants | <50 Days | Probiotics treatment significantly reduced crying time partly due to the increased expression of CC-chemokine receptor Meanwhile, there was no significant difference in the experimental groups in term of IL-10. |
| Gerasimov et al. [31] | Phase II randomized parallel group prospective controlled multi-center dietary study. | Lactobacillus rhamnosus 19070- 2 and Lactobacillus reuteri 12246 (125×106 CFU/day), vitamin D3 (200 IU/day), fructooligosaccharides (3.33 mg/day) | 28 Days | 168 BF infants | 4–12 Weeks | Significant reduction of crying and fussing after 28 days of probiotic administration. |
| Sung et al. [32] | Double-blind, placebocontrolled randomized trial. | Lactobacillus reuteri DSM 17938 (1×108 CFU/day) | 30 Days | 167 BF or FF infants | <3 Months | There was not a significant difference in crying time, fecal calprotectin levels, or Escherichia coli load probiotic group cried 49 minutes more than the placebo group |
| Savino et al. [26] | A double-blind, placebo-controlled randomized trial | Lactobacillus reuteri DSM 17938 (1 × 108 CFU/day) | 30 Days | 87 BF infants | <12 Weeks | Significantly shorter crying time in the infants received probiotics. |
| Forkhead box P3 (FOXP3) significantly increased with probiotic consumption. | ||||||
| Increased Lactobacillus and reduced fecal calprotectin were observed in the probiotic group. | ||||||
| Ashraf et al. [33] | A nonblinded randomized controlled trial | Lactobacillus reuteri (108 CFU/day) | 7 Days | 90 BF infants | 21–90 Days | Improvement of colic symptoms was associated with the probiotic consumption |
| Giglione et al. [34] | A pilot, controlled, randomized, and doubleblind study | Bifidobacterium breve B632 and BR03 (5 cc/108) | 90 Days | 60 FF and BF infants | | Significant reduction of the mean crying time in the probiotic group was observed after treatment for 3 months. |
| Baldassarre et al. [35] | A double-blind, randomized, placebo-controlled clinical trial | Lactobacillus paracasei DSM 24733, Lactobacillus plantarum DSM 24730, Lactobacillus acidophilus DSM 24735, Lactobacillus delbrueckii subsp. bulgaricus DSM 24734, Bifidobacterium longum DSM 24736, Bifidobacterium breve DSM 24732, Bifidobacterium infantis DSM 24737, and Streptococcus thermophilus DSM 24731 (5×109 CFU/day) | 21 days | 62 BF Infants | 30–90 Days | Significant reduction of crying time in comparison with the placebo as well as higher responders to treatment was observed in the probiotic group. |
| No significant difference were observed regarding bowel movements, microbiota composition or stool consistency. |
CFU, colony-forming unit; BF, breast-fed; FF, formula-fed.