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 | ||||||||
Type of study | ||||||||
Quality | ||||||||
Firmansyah et al. 2009 [29] | Intervention: | Outcome: | Outcome | Intervention | Control | Mean difference (CI) | p-value | |
Indonesia | Age: 12 months | Weight, Length, Head circumference, Body Mass Index (BMI) | Sample size | 161 | 153 | |||
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/m^{2}) | 16.0 | 15.9 | Not reported | Not reported | |||
Length: Length after 4 months (cm) | ||||||||
Head circumference: Head circumference after 4 months (cm) | ||||||||
BMI: kg/m^{2} | ||||||||
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 | ||
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 | Control | Mean difference | p-value | |
Australia | Age: <10 days | Weight, Length, Head Circumference, BMI | Sample size: | 62 | 62 | |||
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/cm^{2}/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/cm^{2}/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 | Control | Mean difference (90% CI) | p-value | |
Italy | Age: <14 days | Weight, height, head circumference | Sample size | 42 | 55 | |||
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 | 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 | Control | Mean difference | p-value | |
Spain | Age: 1 month | Weight, Height, Head Circumference | Sample size | 61 | 60 | |||
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 | ||||||||
Author, year | Sample details | Outcomes and units of measurement | Results | |||||
Country | ||||||||
Type of study | ||||||||
Quality | ||||||||
Nutritional status | ||||||||
Sazawal et al. 2010 [16] India | Intervention: | Outcomes: | Outcome | Intervention | 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 | ||||||||
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%) | ||||||||
Stunted | ||||||||
I: 137 (43.9%) C: 157 (50.3%) | ||||||||
Wasted and stunted | ||||||||
I: 53 (17.0%) C: 46 (14.7%) | ||||||||
Saran et al., 2002 [13] | Intervention: | Outcomes: | Outcome | Intervention | 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 | ||||||||
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 | 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 | ||||||||
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 | 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: | |||||||
There was an unclear risk of bias in adequate sequence generation, allocation concealment and blinding. | Age: 15–54 monthss | |||||||
Nutritional status | ||||||||
Underweight | Sample size: 40 | |||||||
I: 20 C: 20 | ||||||||
Severe Underweight | ||||||||
I: 7 C:10 | ||||||||
Normal Bodyweight | ||||||||
I:10 | ||||||||
C:9 |