Table 9 |
|||||
| Summary of findings table: probiotic studies | |||||
| Effects of infant formula containing Probiotics on clinical outcomes in full term infants | |||||
| Patient or population: Full term infants, Settings: Multi-centre trials (hospitals), Intervention: Infant formula with probiotics, Comparison: Conventional infant formula | |||||
| Outcomes | Illustrative comparative risks* (95% CI) | Measure of effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | |
| Assumed risk | Corresponding risk | ||||
| Conventional formula | Infant formula with probiotics | ||||
| Weight gain (g/day) for boys | The mean (SD) weight gain (g/day) for boys in the control group ranged from 30.9 (6.1) to 32.8 (4.1) | The mean weight gain (g/day) for boys in the intervention groups was 1.64 higher (0.36 lower to 3.64 higher) | MD (95% CI): 1.64 (−0.36 to 3.64) | 158 (4 studies) | ⊕⊕⊝⊝ |
| Follow-up: 4 to 7 months | low1,2 | ||||
| Weight gain (g/day) for girls | The mean (SD) weight gain (g/day) for girls in the control group ranged from 26.5 (4.9) to 29 (6.3) | The mean weight gain (g/day) for girls in the intervention groups was 0.76 higher (2.57 lower to 4.09 higher) | MD (95% CI): 0.76 (−2.57 to 4.09) | 170 (4 studies) | ⊕⊕⊝⊝ |
| Follow-up: 4 to 7 months | low3,4,5 | ||||
| Length gain (mm/month) for boys | The mean (SD) length gain (mm/month) for boys in the control group ranged from 31.36 (4.48) to 37.3 (4.9) | The mean length gain (mm/month) for boys in the intervention groups was 0.37 lower (1.64 lower to 0.9 higher) | MD (95% CI): -0.37 (−1.64 to 0.90) | 158 (4 studies) | ⊕⊕⊝⊝ |
| Follow-up: 4 to 7 months | low6,7 | ||||
| Length gain (mm/month) for girls | The mean (SD) length gain (mm/month) for girls in the control group ranged from 28 (3.64) to 32 (4.6) | The mean length gain (mm/month) for girls in the intervention groups was 0.32 higher (0.81 lower to 1.45 higher) | MD (95% CI): 0.32 (−0.81 to 1.45) | 165 (4 studies) | ⊕⊕⊝⊝ |
| Follow-up: 4 to 7 months | low8,9 | ||||
| Head circumference gain (mm/month) for boys | The mean (SD) head circumference gain (mm/month) for boys in the control group ranged from 17.5 (3.4) to 35.28 (7) | The mean head circumference gain (mm/month) for boys in the intervention groups was 0.76 higher (1.02 lower to 2.54 higher) | MD (95% CI): 0.76 (−1.02 to 2.54) | 125 (3 studies) | ⊕⊕⊝⊝ |
| Follow-up: 4 to 7 months | low10,11 | ||||
| Head circumference gain (mm/month) for girls | The mean (SD) head circumference gain (mm/month) for girls in the control group ranged from16 (3) to 36.68 (15.4) | The mean head circumference gain (mm/month) for girls in the intervention groups was 0.27 higher (0.7 lower to 1.23 higher) | MD (95% CI): 0.27 (−0.70 to 1.23) | 139 (3 studies) | ⊕⊕⊝⊝ |
| Follow-up: 4 to 7 months | low12,13 | ||||
| Bifidobacteria -log10(CFU) per gram of stool | The mean (SD) bifidobacteria -log10(cfu) per gram of stool in the control group ranged 9.75 (0.5) to 10.11 (1.67) | The mean bifidobacteria -log10(cfu) per gram of stool in the intervention groups was 1.27 lower (2.03 to 0.51 lower) | MD (95% CI): -1.27 (−2.03 to −0.51) | 57 (2 studies) | ⊕⊕⊝⊝ |
| low14, 15 | |||||
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the measure of effect of the intervention (and its 95% CI). CI: Confidence interval, CFU: colony forming units, MD: Mean Difference, RR: Risk ratio.
GRADE Working Group grades of evidence. High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
1 Small sample size n=158, 95% CI includes no effect.
2 Possible publication bias.
3 Unexplained heterogeneity).
4 Small sample size n=170.
5 Possible publication bias.
6 Small sample size n=158, 95% CI includes no effect.
7 Possible publication bias.
8 Small sample size n=165, 95% CI includes no effect.
9 Possible publication bias.
10 Small sample size n=125, 95% CI includes no effect.
11 Possible publication bias.
12 Small sample size n=139.
13 Possible publication bias.
14 Small sample size n=57.
15 Possible publication bias.
Mugambi et al. Nutrition Journal 2012 11:81 doi:10.1186/1475-2891-11-81
