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Published on: January 27, 2019
Oral supplementation with probiotics in very-low-birth-weight preterm infants: a randomized, double-blind,
Carole Rougé1, Hugues Piloquet, Marie-José Butel
1INRA UMR 1280, Physiologie des Adaptations Nutritionnelles, INRA and University of Nantes, Human Nutrition Research Center, Nantes, France.
Insights
Probiotic supplementation did not improve enteral feeding tolerance in very low birth weight infants. However, it may benefit those weighing over 1000g by accelerating full enteral feeding. Safety and efficacy remain key considerations.
Area of Science:
- Neonatalogy
- Gastroenterology
- Microbiome Research
Background:
- Probiotic use in premature infants is suggested to improve intestinal function, but mechanisms and safety in extremely low-birth-weight infants are not well understood.
- Enteral feeding tolerance is crucial for preterm infant development and requires careful management.
Purpose of the Study:
- To assess the efficacy of probiotics in enhancing digestive tolerance to enteral feeding in preterm infants with very low or extremely low birth weight.
Main Methods:
- A bicentric, double-blind, randomized controlled trial involving 94 preterm infants (45 probiotics, 49 placebo).
- Probiotics administered were Bifidobacterium longum BB536 and Lactobacillus rhamnosus GG (BB536-LGG).
- Primary endpoint: percentage of infants receiving >50% nutritional needs via enteral feeding by day 14; sequential analysis used.
Main Results:
- The trial was stopped early due to a lack of significant effect on the primary endpoint (57.8% probiotic vs. 57.1% placebo, P=0.95).
- Infants weighing >1000g showed a shorter time to reach full enteral feeding with probiotics (P=0.04).
- No significant changes in intestinal microbiota composition or fecal calprotectin were observed; probiotic strain colonization was absent in infants < or =1000g.
Conclusions:
- BB536-LGG supplementation may not enhance gastrointestinal tolerance to enteral feeding in very-low-birth-weight infants.
- A potential benefit was observed in infants weighing >1000g, with improved gastrointestinal tolerance.
- Further research may be needed to clarify specific benefits and safety profiles in different preterm infant subgroups.
Background:
Although recent reports suggest that supplementation with probiotics may enhance intestinal function in premature infants, the mechanisms are unclear, and questions remain regarding the safety and efficacy of probiotics in extremely low-birth-weight infants.
Objective:
The objective was to evaluate the efficacy of probiotics on the digestive tolerance to enteral feeding in preterm infants born with a very low or extremely low birth weight.
Design:
In a bicentric, double-blind, randomized controlled clinical trial that was stratified for center and birth weight, 45 infants received enteral probiotics (Bifidobacterium longum BB536 and Lactobacillus rhamnosus GG; BB536-LGG) and 49 received placebo. The primary endpoint was the percentage of infants receiving >50% of their nutritional needs via enteral feeding on the 14th day of life. A triangular test was used to perform sequential analysis.
Results:
The trial was discontinued after the fourth sequential analysis concluded a lack of effect. The primary endpoint was not significantly different between the probiotic (57.8%) and placebo (57.1%) groups (P = 0.95). However, in infants who weighed >1000 g, probiotic supplementation was associated with a shortening in the time to reach full enteral feeding (P = 0.04). Other than colonization by the probiotic strains, no alteration in the composition of intestinal microbiota or changes in the fecal excretion of calprotectin was observed. No colonization by probiotic strains was detected in infants who weighed < or =1000 g, presumably because of more frequent suspensions of enteral feeding, more courses of antibiotic treatment, or both.
Conclusions:
Supplementation with BB536-LGG may not improve the gastrointestinal tolerance to enteral feeding in very-low-birth-weight infants but may improve gastrointestinal tolerance in infants weighing >1000 g. This trial was registered at clinicaltrials.gov as NCT 00290576.
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