From: Effects of probiotics on child growth: a systematic review
Section 1: In healthy children | ||||||||
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Author, year | Sample details | Outcomes and units of measurement | Results | |||||
Country | Â | |||||||
Type of study | Â | |||||||
Quality | Â | |||||||
Firmansyah et al. 2009 [29] | Intervention: | Outcome: | Outcome | Intervention | Â | Control | Mean difference (CI) | p-value |
Indonesia | Age: 12 months | Weight, Length, Head circumference, Body Mass Index (BMI) | Sample size | 161 | Â | 153 | Â | |
RCT | Sample size: 199 |  | Weight (g/day) | 7.57 ± 4.13 |  | 6.64 ± 4.08 | 0.93 (0.12-1.95) | 0.025 |
Quality: | Control: | Units of measurement: | Change in weight-for-age | 0.11 ± 0.40 |  | 0.02 ± 0.40 | 0.09 (0.01-0.18) | 0.036 |
Unclear risk of bias for allocation concealment | Age: 12 months | Weight: | Weight (g) | 9711 ± 1142 |  | 9643 ± 1218 | Not reported | Not reported |
 | Sample size: 194 | Weight gain (g/day) | Length (cm) | 77.8 ± 3.0 |  | 77.9 ± 3.4 | Not reported | Not significant |
 |  | Change in weight-for-age after 4 months | Head circumference (cm) | 46.3 ± 1.3 |  | 46.4 ± 1.4 | Not reported | Not significant |
 |  | Weight (g) | BMI (kg/m2) | 16.0 |  | 15.9 | Not reported | Not reported |
 |  | Length: Length after 4 months (cm) |  |  |  |  |  | |
 |  | Head circumference: Head circumference after 4 months (cm) |  |  |  |  |  | |
 |  | BMI: kg/m2 |  |  |  |  |  | |
Scalabrin et al. 2009 [33] | Intervention: | Outcome: | Outcome | Intervention 1- EHF + P | Intervention 2 - PHF + P | Control EHF | Mean difference | p-value |
USA | Age: 14 days | Weight, Length, Head | Sample size | 63 | 77 | 70 | Â | Â |
RCT | Sample size: | circumference | Weight gain (g/day) | 28.4 ± 0.67 | 26.8 ± 0.76 | 27.6 ± 0.72 | Not reported | Not Significant |
Quality: | -Extensively hydrolysed formula with probiotic (EHF + P): 94 | Units of measurement: | Length (cm/day) | 0.11 ± 0.002 | 0.11 ± 0.002 | 0.11 ± 0.002 | No difference |  |
Low risk of bias for all parameters | -Partially hydrolysed formula with probiotic (PHF + P): 98 | Weight: | Head circumference (cm/day) | 0.05 ± 0.001 | 0.05 ± 0.001 | 0.05 ± 0.001 | No difference |  |
 |  | Weight gain (g/day) | ANOVA, 1-tailed t-tests |  |  |  |  |  |
 | Control: | Length: change in length (cm/day) |  |  |  |  |  |  |
 | Age: 14 days |  |  |  |  |  |  |  |
 | Sample size: Extensively hydrolysed formula without probiotic (EHF): 94 | Head circumference: |  |  |  |  |  |  |
 |  | Change in head circumference (cm/day) |  |  |  |  |  |  |
Saavedra et al. 2004 [32] | Intervention: | Outcome: | Outcome | Intervention 1 (HS) | Intervention 2 (LS) | Control | Mean difference | p-value |
USA | Age: 3–24 months | Weight and Height | Sample size | 39 | 39 | 40 |  |  |
RCT | Sample size: | Units of measurement: | Change in weight-for-age | 0.09 ± 0.64 | 0.06 ± 0.72 | 0.16 ± 0.69 | Not reported | Not significant |
Quality: | -High Supplement probiotic in formula (HS): 39 | Weight: | Change in weigh-for-length | 0.40 ± 0.85 | 0.53 ± 1.10 | 0.45 ± 0.75 | Not reported | Not significant |
Unclear risk of bias in allocation concealment | -Low Supplement probiotic in formula (LS): 39 | change in weight-for-age z-score | Change in height-for-age | −0.06 ± 0.44 | −0.09 ± 0.60 | −0.04 ± 0.59 | Not reported | Not significant |
 | Control- formula | change in weight-for-length score |  |  |  |  |  |  |
 | Age: 3–24 months | Height: |  |  |  |  |  |  |
 | Sample size: 40 | change in height- for-age z-score |  |  |  |  |  |  |
Gibson et al. 2009 [30] | Intervention: | Outcome: | Outcome | Intervention | Â | Control | Mean difference | p-value |
Australia | Age: <10 days | Weight, Length, Head Circumference, BMI | Sample size: | 62 | Â | 62 | Â | Â |
RCT | Sample size: 72 | Units of measurement: | Weight gain (g/day) | M(24) 33 · 6 ± 7 · 5 |  | M(19) 31 · 6 ± 7 · 7 | 1.5 (−0.08-3.1) | Not significant |
Quality: | Control: | Weight : Weight gain (g/day) |  | F(31) 28 · 1 ± 5 · 8 |  | F(24) 26 · 5 ± 4 · 9 |  |  |
Low risk of bias in all parameters | Age: <10 days Sample size: 70 | Length: Length gain (mm/month) | Length gain (mm/month) | M(24) 35 ± 3 · 7 |  | M(19) 37 · 3 ± 4 · 9 | Not reported | Not significant |
 |  | Head circumference: Change in head circumference (mm/month) |  | F(27) 32 · 8 ± 4 |  | F(23) 32 ± 4 · 6 |  |  |
 |  | BMI: change in BMI per month (kg/cm2/month) | Head circumference (mm/month) | M(23) 18 ± 2 · 4 |  | M(19) 17 · 5 ± 3 · 4 | Not reported | Not significant |
 |  |  |  | F(29) 16 · 1 ± 2 · 7 |  | F(24) 16 ± 3 |  |  |
 |  |  | BMI (kg/cm2/month) | M(24) 1 · 1 ± 0 · 6 |  | M(19) 1 ± 0 · 5 | Not reported | Not significant |
 |  |  |  | F(27) 0 · 9 ± 0 · 5 |  | F(23) 0 · 8 ± 0 · 4 |  |  |
 |  |  | ANOVA correcting for sex |  |  |  |  |  |
Zeigler et al. 2003 [34] | Intervention: | Outcome: | Outcome | Intervention (RP + P) | Intervention (RP) | Control | Mean difference | p-value |
USA | Age: 6–10 days | Weight and Height | Sample size | 28 | 27 | C:33 |  |  |
RCT | Sample size: | Units of measurement: | Weight gain (g/day) | 28.13 ± 4.63§ | 29.3 ± 5.41§ | 31.05 ± 5.88§ | Not Reported | 0.229 |
Quality: | RP + P | Weight: g/day |  |  |  |  |  |  |
The risk of bias in adequate sequence generation, allocation concealment and blinding was unclear while there was a high risk of bias in reporting of incomplete outcome data | (Bifidobacterium lactis in reduced protein formula): 40 | Length: mm/day |  | M 13 32.1 ± 5.2 | M 8 32.0 ± 4.7 | M 19 32.2 ± 5.2 |  |  |
 |  |  |  | F 15 24.7 ± 4.9 | F 19 28.2 ± 5.8 | F 14 29.5 ± 6.9 |  |  |
 | RP (Reduced protein formula): 40 |  | Length gain (mm/day) | M 13 1.14 ± 0.11 | M 8 1.14 ± 0.09 | M19 1.16 ± 0.09 | Not reported | 0.377 |
 |  |  |  | F 15 1.02 ± 0.07 | F 19 1.06 ± 0.10 | F14 1.07 ± 0.14 |  |  |
 | Control: |  |  |  |  |  |  | |
 | Age: 6–10 days |  |  |  |  |  |  | |
 | Sample size |  |  |  |  |  |  | |
 | Normal protein formula: 42 |  |  |  |  |  |  | |
Puccio et al. 2007 [31] | Intervention: | Outcomes: | Outcome | Intervention | Â | Control | Mean difference (90% CI) | p-value |
Italy | Age: <14 days | Weight, height, head circumference | Sample size | 42 | Â | 55 | Â | |
RCT | Sample size: 65 | Units of measurement: | Weight (g/day) | Not reported |  | Not reported | 0.50 (−1.48 ± 2.48) | Not reported |
Quality: Risk of bias was unclear in both adequate sequence generation and allocation concealment | Control: | Weight: weight gain (g/day) | Height (mm/month) | M 35.1 ± 4.2 |  | M: 35 ± 4.4 | Not reported | 0.1 |
 | Age: <14 days | Height: change in height (mm/month) |  | F 32.2 ± 4.3 |  | F : 32.2 ± 4.6 |  | 0.1 |
 | Sample size: 69 | Head circumference: Change in head circumference (mm/month) | Head circumference (mm/month) | M: 17.9 ± 2.7 |  | M : 17.4 ± 2.9 | Not reported | >0.1 for all |
 |  |  |  | F: 16.0 ± 2.8 |  | F: 15.5 ± 3.0 |  | |
Huet et al., 2006 [35] | Intervention: | Outcomes: | Outcome | Intervention | Â | Control | Mean difference | p-value |
France | Age: 1–28 days | Weight, Height, Head circumference | Sample size | 117 |  | 86 |  | |
CCT | Sample size: 117 | Units of measurement: | Weight gain (g/day) | 29.6 ± 6.6 |  | 29.8 ± 6.3 | Not reported | Not significant |
Quality: The study had high risk of bias in adequate sequence generation, allocation concealment and blinding. | Control: | Weight: weight gain (g/day) | Height (cm/day) | 0.110 ± 0.018 |  | 0.111 ± 0.018 | Not reported | Not significant |
 | Age: 1-28 days | Height: height gain (cm/day) | Head circumference(mm/day) | 0.56 ± 0.12 |  | 0.55 ± 0.12 | Not reported | Not significant |
 | Sample size: 86 | Head circumference: change in head circumference (mm/day) |  |  |  |  |  |  |
Gil-Campos et al. 2011 [27] | Intervention: | Outcomes: | Outcome | Intervention | Â | Control | Mean difference | p-value |
Spain | Age: 1 month | Weight, Height, Head Circumference | Sample size | 61 | Â | 60 | Â | |
RCT | Sample size: 71 | Units of measurement: | Weight gain (g/day) | 24.8 ± 5.1 |  | 25.3 ± 6.0 | Not reported | Not significant |
Quality: There was low risk of bias in all parameters. | Control: | Weight: weight gain (g/day), weight at 6 months (kg), weight-for-age z-scores at 6 months | Length gain (mm/day) | 0.96 ± 0.3 |  | 0.90 ± 0.2 | Not reported | Not significant |
 | Age: 1 month | Length: Length gain (mm/day), Length at 6 months (cm), Length for age z-scores at 6 months | Head Circumference (mm/day) | 0.43 ± 0.1 |  | 0.421 ± 0.1 | Not reported | Not significant |
 |  |  | Weight at 6 months (kg) | 8.0 ± 0.9 |  | 7.9 ± 1.0 | Not reported | Not significant |
 | Sample size: 66 | Head Circumference: Head Circumference at 6 months (cm), Head circumference z-scores at 6 months | Length at 6 months (cm) | 68.1 ± 3.4 |  | 66.6 ± 2.5 | Not reported | 0.038 |
 |  |  | Head Circumference at 6 months (cm) | 43.7 ± 1.6 |  | 43.7 ± 1.3 | Not reported | Not significant |
 |  |  | Weight for age z-scores at 6 months | Not reported |  | Not reported | Not reported | p = 0.061 |
 |  |  | Length for age z-scores at 6 months | Not reported |  | Not reported | Not reported | p = 0.021 |
 |  |  | Head circumference z-scores at 6 months | Not reported |  | Not reported | Not reported | p = 0.453 |
Section 2: In under-nourished children | Â | Â | Â | Â | ||||
Author, year | Sample details | Outcomes and units of measurement | Results | Â | Â | Â | Â | |
Country | Â | |||||||
Type of study | Â | |||||||
Quality | Â | |||||||
Nutritional status | Â | Â | Â | Â | Â | Â | Â | Â |
Sazawal et al. 2010 [16] India | Intervention: | Outcomes: | Outcome | Intervention | Â | Control | Mean difference | p-value |
RCT | Age: 1–3 years | Weight, height | Sample size | 257 |  | 245 |  | |
Quality: The risk of bias was low for all parameters | Sample size: 312 | Units of measurement: | Weight gain (g/year) | 2,130 ± 590 |  | 2,000 ± 590 | 130 (30–230) | 0.02 |
None severely malnourished | Control: | Weight: weight gain (g/year), change in weight for age z-score | Change in weight-for-age z-score | 0.34 ± 0.54 |  | 0.26 ± 0.54 | 0.08 (−0.02 to 0.17) | 0.12 |
Nutritional status | Â | Â | Â | Â | Â | Â | Â | Â |
Normal | Age: 1–3 years |  | Height (cm/year) | 8.49 ± 1.41 |  | 8.28 ± 1.35 | 0.20 (−0.04 to 0.45) | 0.09 |
I: 107 (34.3%) C: 95 (30.4%) | Sample size: 312 | Height: height gain (cm/year), change in height for age z-score after one year | change in height for age z-score after 1 year | 0.21 ± 0.42 |  | 0.18 ± 0.49 | 0.03 (−0.06 to 0.10) | 0.55 |
Wasted |  |  | Difference in weight/height | 0.44 ± 0.65 |  | 0.34 ± 0.63 | 0.09 (−0.01 to 0.21) | 0.09 |
I: 15 (4.8%) C: 14 (4.5%) | Â | |||||||
Stunted | Â | Â | Â | |||||
I: 137 (43.9%) C: 157 (50.3%) | Â | |||||||
Wasted and stunted | Â | |||||||
I: 53 (17.0%) C: 46 (14.7%) | Â | |||||||
Saran et al., 2002 [13] | Intervention: | Outcomes: | Outcome | Intervention | Â | Control | Mean difference | p-value |
India | Age: 2–5 years | Weight, height | Sample size | 50 |  | 50 |  | |
Non-randomised controlled trial | Sample size: 50 | Units of measurement: | Weight (g/6 months) | 1,290 ± 730 |  | 810 ± 840 | 0.002 | Not reported |
Quality: high risk of bias for adequate sequence generation, allocation concealment and blinding. | Control: | Weight: weight gain (g per 6 months) | Height: (cm/6months) | 3.21 ± 1.48 |  | 1.74 ± 0.80 | Not reported | 0.0001 |
Nutritional status | Â | Â | Â | Â | Â | Â | Â | Â |
Stunted (height for age) and matched in both groups | Age: 2–5 years | Height: height gain (cm per 6 months) |  |  |  |  |  |  |
 | Sample size: 50 |  |  |  |  |  |  |  |
He et al., 2005 [12] | Intervention: | Outcomes: | Outcome | Intervention | Â | Control | Mean difference | p-value |
China | Age: 3–5 years | Weight, height | Sample size | 201 |  | 201 |  | |
RCT | Sample size: 201 |  | Gram per 3, 6 and 9 months | 700 ± 430 |  | 490 ± 350 | Not reported | 0.01 |
Quality: | Control: | Units of measurement: Weight: Weight gain (g per 3, 6 and 9 months), Change in weight-for-age at 3, 6 and 9 months |  | 980 ± 620 |  | 800 ± 600 |  | 0.01 |
There was an unclear risk of bias in adequate sequence generation and high risk of bias in both allocation concealment and blinding | Age: 3–5 years |  | 1,420 ± 760 |  | 1,200 ± 670 |  | 0.01 | |
 | Sample size: 201 | Change in weight-for-age at 3, 6 and 9 months | 0.139 ± 0.228 |  | 0.031 ± 0.184 |  | 0.01 | |
Nutritional status | Â | Â | Â | Â | Â | Â | Â | Â |
Undernourished - weight for age and/or height for age were below reference values |  | Height: change in height for age z-scores at 9 months |  | 0.058 ± 0.306 |  | −0.047 ± 0.28 |  | 0.01 |
 |  |  |  | 0.078 ± 0.365 |  | −0.043 ± 0.28 |  | 0.01 |
 |  |  | Change in height for age z-scores at 9 months | 0.123 ± 0.168 |  | 0.077 ± 0.175 | Not reported | <0.01 |
Surono et al. 2011 [28] Indonesia | Intervention: | Outcomes: Weight | Outcome | Intervention | Â | Control | Mean difference | p-value |
RCT | Age: 15–54 months | Units of measurement: | Sample size | 37 |  | 39 |  |  |
 | Sample size: 39 | Weight: Mean gain in bodyweight after 90 days | Mean bodyweight gain (g) | 1280 ± 940 |  | 990 ± 990 | Not reported | Not reported |
Quality: | Control: | Â | ||||||
There was an unclear risk of bias in adequate sequence generation, allocation concealment and blinding. | Age: 15–54 monthss |  | ||||||
Nutritional status | Â | |||||||
Underweight | Sample size: 40 | Â | ||||||
I: 20 C: 20 | Â | |||||||
Severe Underweight | Â | |||||||
I: 7 C:10 | Â | |||||||
Normal Bodyweight | Â | |||||||
I:10 | Â | |||||||
C:9 | Â |