Table 10

Summary of findings table: prebiotic studies
Effects of infant formula containing Prebiotics on clinical outcomes in full term infants
Patient or population: Full term infants, Settings: Multi-centre trials, Intervention: Infant formula with prebiotics, Comparison: Conventional 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 prebiotics
Weight gain (g/day) The mean (SD) weight gain (g/day) in the control group ranged from 26.4 (3.7) to 40.59 (3.95) The mean weight gain (g/day) in the intervention groups was 0.97 higher (0.24 to 1.7 higher) MD (95% CI): 0.97 (0.24 to 1.70) 861 (8 studies) ⊕⊕⊝⊝
Follow-up: 1 to 6 months low1,2,3
Length gain (cm/week) The mean (SD) length gain (cm/week) in the control group ranged from 0.74 (0.1) to 0.96 (0.11) The mean length gain (cm/week) in the intervention groups was 0.01 higher (0.01 lower to 0.04 higher) MD (95% CI): 0.01(−0.01 to 0.04) 697 (7 studies) ⊕⊕⊝⊝
Follow-up: 1 to 6 months low4,5,6
Head circumference gain (cm/ week) The mean (SD) head circumference gain (cm/ week) in the control group ranged from 0.34 (0.05) to 0.63 (0.1) The mean head circumference gain (cm/ week) in the intervention groups was 0.01 lower (0.02 lower to 0 higher) MD (95% CI): -0.01 (−0.02 to 0.00) 438 (3 studies) ⊕⊕⊝⊝
Follow-up: 1.5 to 6 months low7,8
Stool frequency (evacuations per day) The mean (SD) stool frequency (evacuations per day) in the control group ranged from1.5 (0.6) to 2.4 (1.64) The mean stool frequency (evacuations per day) in the intervention groups was 0.18 higher (0.06 to 0.3 higher) MD (95% CI): 0.18 (0.06 to 0.30) 579 (4 studies) ⊕⊕⊝⊝
Follow-up: 1 to 6 months low9,10
Diarrhea Study population RR 0.62 (0.19 to 1.99) 237 (2 studies) ⊕⊕⊝⊝
Follow-up: 4 to 12 months 23 per 100 14 per 100 (4 to 46) low11,12
Moderate
19 per 100 12 per 100 (4 to 38)
URTI Study population RR 0.74 (0.32 to 1.73) 409 (2 studies) ⊕⊕⊝⊝
Follow-up: 6 to 12 months 45 per 100 33 per 100 (14 to 77) low13, 14, 15
Moderate
44 per 100 33 per 100 (14 to 76)
Bifidobacteria -log10(CFU) per gram stool The mean(SD) bifidobacteria -log10(cfu) per gram stool in the control group ranged from 6(0.9) to 10.11 (1.67) The mean bifidobacteria -log10(cfu) per gram stool in the intervention groups was 0.92 higher (0.02 lower to 1.86 higher) MD (95% CI): 0.92 (−0.03 to 1.86) 280 (5 studies) ⊕⊕⊝⊝
Follow-up: 1 to 6 months low16, 17, 18
Lactobacilli -log10(CFU) per gram stool The mean (SD) lactobacilli -log10 (cfu) per gram stool in the control group ranged from 3.95 (1.57) to 4.27 (2.02) The mean lactobacilli -log10(cfu) per gram stool in the intervention groups was 1.12 higher (0.44 lower to 2.67 higher) MD (95% CI): 1.12 (−0.44 to 2.67) 202 (3 studies) ⊕⊕⊝⊝
Follow-up: 3 to 6 months low19,20,21

*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 Allocation concealment not clearly described in 6 studies.

2 Blinding not clearly demonstrated or described in 7 studies.

3 Possible publication bias.

4 Allocation concealment not clearly demonstrated in 5 studies.

5 Blinding not clearly demonstrated in 6 studies.

6 Possible publication bias.

7 Blinding not clearly described in 2 studies.

8 Possible publication bias.

9 Incomplete outcome data (with no reasons given for missing data) was present in 1 study.

10 Possible publication bias.

11 Small sample size n=237, 95% CI includes no effect.

12 Possible publication bias.

13 Unexplained heterogeneity.

14 95% CI includes no effect.

15 Possible publication bias.

16 Unexplained heterogeneity.

17 Small sample size n=280.

18 Possible publication bias.

19 Unexplained heterogeneity.

20 Small sample size n=202.

21 Possible publication bias.

Mugambi et al.

Mugambi et al. Nutrition Journal 2012 11:81   doi:10.1186/1475-2891-11-81

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