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Lactobacillus rhamnosus GG does not significantly impact composite outcomes in VLBW infantsTrial shows probiotic LGG does not improve outcomes for infants

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Key Takeaway
Note that Lactobacillus rhamnosus GG did not significantly improve primary outcomes in VLBW infants with NEC or sepsis.

This randomized controlled trial enrolled 236 enterally-fed very low birth weight (VLBW) infants with a gestational age of 32 weeks or less. The study aimed to evaluate the impact of oral Lactobacillus rhamnosus GG (LGG) administered from feed initiation until 35 weeks of corrected gestational age compared to breast milk alone.

The primary outcome was a composite of sepsis, necrotising enterocolitis (NEC), or mortality. In the LGG group, the incidence was 30.4% (35 cases), while the control group showed 27.2% (33 cases). The results were not statistically significant (RR 0.85; 95%CI 0.48-1.50, P = 0.592).

Secondary outcomes included time to reach full feeds, time to regain birth weight, and durations of hospital stay, mechanical ventilation, or antimicrobial therapy. No significant differences were observed in any secondary measures (P > 0.05). The study was an open-label design.

LGG as a single component probiotic did not show significant benefit for the primary composite outcome in VLBW infants. Clinical application of LGG specifically for these outcomes remains unsupported by this evidence.

How this fits prior evidence

How this fits prior evidence: This finding addresses a gap regarding probiotic interventions for neonatal complications. While previous coverage noted that bovine milk fortifiers are non-inferior to human milk fortifiers for NEC and sepsis in pre-term newborns, this study indicates that the addition of LGG as a single component does not provide additional benefit for the composite outcome of sepsis, NEC, or mortality.

When babies are born very small and early, they face serious risks like sepsis (a severe infection) and necrotising enterocolitis (a dangerous intestinal condition). Doctors often look for ways to protect these fragile infants during their first weeks of life. This study looked at whether a specific probiotic called Lactobacillus rhamnosus GG could provide that extra layer of protection.

The researchers followed 236 very low birth weight infants who were fed through a tube. They compared those who received the LGG probiotic with those who only received breast milk. The goal was to see if the probiotic would lower the rates of infection, intestinal issues, or death, and help babies reach milestones like full feeding and gaining weight faster.

The results showed no significant difference between the two groups. Infants receiving the probiotic had a 30.4% rate of complications compared to 32.7% in the group without it. There were also no measurable differences in how long infants stayed in the hospital, how long they needed breathing machines, or how quickly they gained weight. Because this was an open-label study, the results are currently limited in scope.

What this means for you:
The probiotic LGG did not show a significant benefit for preventing complications in very low birth weight infants.

Common questions

Does this probiotic protect babies from infections?

The study of 236 infants found no significant difference in the composite outcome of sepsis, necrotising enterocolitis, or mortality between those who received the LGG probiotic and those who did not. The rates were 30.4% for the LGG group and 27.2% for the control group.

Does it help babies start eating normally faster?

No significant difference was found regarding how long it took infants to reach full feeds. The LGG group reached full feeds in 11.9 days, while the control group reached them in 12.0 days.

Does it shorten hospital stays or breathing tube use?

The study found no significant difference between the two groups regarding the duration of hospital stays, time spent on mechanical ventilation, or the length of antimicrobial therapy.

Study Details

Study typeRct
EvidenceLevel 2
PublishedJul 2026
View Original Abstract ↓
OBJECTIVES: To evaluate the efficacy of oral Lactobacillus rhamnosus GG (LGG) in reducing neonatal enterocolitis (NEC), sepsis and mortality in very low birth weight (VLBW) infants. METHODS: This open-label randomized controlled trial included enterally-fed VLBW infants with gestational age ≤ 32 weeks; those with gastrointestinal anomalies, severe birth asphyxia (APGAR score < 3 at 5 min), cyanotic congenital heart disease, and those not started on feeds by 14 days of life were excluded. Participants were randomized to receive either no probiotic (control) group, or probiotic (LGG; intervention) group. The intervention group received the first dose of LGG (probiotic) at feed initiation and was continued till 35 weeks of corrected gestational age. The control group received only breast milk. Clinical outcomes (mortality, NEC, sepsis) were compared in both groups during hospital stay. RESULTS: A total of 236 infants were enrolled. The primary composite outcome of sepsis, NEC or mortality was seen in 35 (30.4%) and 33 (27.2%) infants, respectively in the LGG and control groups (RR 0.85; 95%CI 0.48-1.50, P = 0.592). The mean (SD) time to reach full feeds was 11.9 (4.2) and 12.0 (5.5) days in the LGG and control groups, respectively; P = 0.561. The mean (SD) time to regain birth weight was 13.5 (3.9) and 13.6 (3.9) days in the LGG and control groups, respectively (P = 0.982). There was no significant difference in duration of hospital stay, duration of mechanical ventilation, or duration of antimicrobial therapy between the two groups (P > 0.05). CONCLUSIONS: Use of LGG as single component probiotic in VLBW infants did not confer any significant benefit on the composite outcome of mortality, sepsis or NEC. TRIAL REGISTRY: Clinical Trial Registry of India; Ref. No. CTRI/2021/03/031724 dated Mar 03, 2021.
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