Table 5.
Effects of a combination of Lactobacillus spp. and Bifidobacterium spp. on NEC occurrence and/or all-cause mortality.
| Study | Country | Treatment | Mortality (no. with event divided by no. in treatment arm) |
NEC (Bell stage ≥ II) frequency (no. with event divided by no. in treatment arm) |
Registered | Sequence generation & Allocation concealment |
Data collectors/outcome (NEC) assessors blinded | Year last enrolled participant | Primary Outcome(s) | Comments | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment | Control | Treatment | Control | |||||||||
| Lin et al.126 | Taiwan | L. acidophilus, B. infantis | 7/180* | 20/187* | 2/180* | 10/187* | No | Low risk | The investigators knew the infants’ group assignments, but NEC was diagnosed by individuals who were not aware of the allocation of the participants. | 2003 | NEC or death | Efficacy not reported by birthweight of participants |
| Lin et al.127 | Taiwan | L. acidophilus, B. bifidum | 2/217† | 9/217† | 4/217 | 14/217 | Yes (NCT00540033)‡ | Low risk | The investigators knew the infants’ group assignments, but NEC was diagnosed by individuals who were not aware of the allocation of the participants. | 2007 | NEC or death | Protective effect not apparent in children whose birth weights were ≤ 1,000 g |
| Samanta et al.128 | India | B. infantis, B. bifidum, B. longum, B. acidophilus | 4/91* | 15/95* | 5/91* | 15/95* | No | Low risk | UTD | 2008 | NEC, sepsis, death, days to reach full feed, DOH were co-primary outcomes | P-values not corrected for multiple comparisons |
| Rougé et al.129 | France | B. longum BB536, L. rhamnosus GG | 2/45 | 4/49 | 1/45 | 2/49 | Yes (NCT00290576)‡ | Low risk | UTD | 2007 | Percent of infants receiving more than half of their nutritional needs enterally | Mortality but not NEC stated as secondary outcome |
| Braga et al.130 | Brazil | L. casei, B. breve | 26/119 | 27/112 | 0/119 | 4/112 | Yes (67165178)§ | Low risk | Low risk | 2008 | NEC | P-value for efficacy in preventing NEC was 0.054 |
| Al-Hosni et al.49 | United States | L. rhamnosus GG, B. infantis | 3/50 | 4/51 | 3/50 | 4/51 | Yes (NCT01164124)‡ | UTD randomization method | UTD | 2009 | Growth velocity, weight gain, volume of feeding | Outcome category unclear but not primary |
| Roy et al.131 | India | L. acidophilus, B. longum, B. bifidum, B. lactis | 7/56 | 8/56 | 2/56 | 2/56 | Yes (CTRI REF/2012/12/004378)¶ | Low risk | UTD | 2013 | Incidence of enteric fungal colonization | NEC stated as secondary outcome |
| Saengtawesin et al.132 | Thailand | L. acidophilus, B. bifidum | 0/31 | 0/29 | 1/31 | 1/29 | No | Low risk | UTD | 2013 | NEC | |
| Van Niekerk et al.133 | South Africa | L. rhamnosus GG, B. infantis | 2/54 (HIV-unexposed) | 5/56 (HIV-unexposed) | 0/54 (HIV-unexposed) | 2/56 (HIV-unexposed) | Yes (NCT01868737)‡ | Low risk | Low risk | 2012 | NEC | |
| 3/37 (HIV-exposed) | 1/37 (HIV-exposed) | 0/37 (HIV-exposed) | 2/37 (HIV-exposed) | |||||||||
UTD = unable to be determined based on information provided.
* Difference in outcome between treatment and control arms was significant.
† Difference in incidence of death not attributable to NEC was significant.