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Updated: Sep 21, 2025

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Published on: January 27, 2019
Maternal and infant probiotic administration for morbidity of very low birth weight infants: a three-arm randomized
Mahtab Matin1, Aziz Homayouni-Rad2, Manizheh Mostafa-Gharehbaghi3
1Student Research Committee, Department of Midwifery, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.
Insights
Oral probiotics, Lacticaseibacillus paracasei, given to mothers or very low birth weight (VLBW) infants reduced infant total serum bilirubin (TSB) levels. Weight gain was not significantly affected after the first week.
Area of Science:
- Neonatal Medicine
- Microbiology
- Clinical Nutrition
Background:
- Very low birth weight (VLBW) infants are susceptible to hyperbilirubinemia and growth faltering.
- Oral probiotics offer a potential therapeutic strategy for improving neonatal outcomes.
- Lacticaseibacillus paracasei is a probiotic strain with potential health benefits.
Purpose of the Study:
- To investigate the efficacy of oral Lacticaseibacasei paracasei administration in reducing total serum bilirubin (TSB) levels in VLBW infants.
- To assess the impact of this probiotic intervention on infant weight gain.
- To compare the effects of administering the probiotic to mothers versus directly to infants.
Main Methods:
- A double-blind, randomized controlled trial was conducted with breastfeeding mothers and their VLBW infants.
- Participants were assigned to three groups: probiotic to mother/placebo to infant, probiotic to infant/placebo to mother, or placebo to both.
- The intervention lasted for 28 days, with assessments of TSB levels and infant weight gain.
Main Results:
- On day 7, TSB levels were significantly lower in both groups receiving the probiotic compared to the placebo group.
- Infant weight gain during the first 7 days was significantly higher in both probiotic intervention groups.
- No significant differences in TSB or weight gain were observed after the first week of intervention.
Conclusions:
- Oral administration of Lacticaseibacillus paracasei to breastfeeding mothers or VLBW infants effectively reduces infant TSB levels.
- The probiotic intervention did not show a significant effect on infant weight gain beyond the first week.
- This suggests a potential role for Lacticaseibacillus paracasei in managing neonatal hyperbilirubinemia.
Purpose:
To determine whether oral probiotic administration (1.5 × 109 CFU/g Lacticaseibacillus paracasei subsp. paracasei) to breastfeeding mothers or to their very low birth weight (VLBW) infants reduces total serum bilirubin (TSB) level and increases weight gain of the infants.
Methods:
In this double-blind trial, breastfeeding mothers and their VLBW infants at 48-72 h of age were allocated into three groups using stratified block randomization; administrating probiotic to the mothers and placebo to their infants, probiotic to the infants and placebo to their mothers, or placebo to the both. The intervention continued for 28 days.
Results:
All 25 mothers and their 26 infants allocated into each group were fully followed up. There were three positive blood culture only in the placebo group. On the 3rd day of intervention, TSB level was not significantly different among the groups but on the 7th day, it was significantly lower in the both probiotic groups compared with the placebo group (mean difference -2.4 mg/dL [95% confidence interval -3.6 to -1.2] in the both comparisons). Mean rank of infant weight gain during the first 7 days of intervention was significantly higher in the both maternal and infant probiotic groups compared with the placebo group (p = 0.007 and p = 0.003, respectively), but there was no statistically significant difference among the groups during the 8th-28th days.
Conclusion:
Administration of Lacticaseibacillus paracasei to breastfeeding mothers of VLBW infants or to their infants reduces infant TSB level but has no significant effect on weight gain after the first week of the intervention.
Trial Registration:
The Iranian Clinical Trials Registry IRCT20100414003706N38. protrospectively registered 24/01/2021.
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