Impact of a multi-strain probiotic administration on peri-rectal colonization with drug-resistant Gram-negative bacteria in preterm neonates.

Background: Infections caused by drug resistant Gram-negative bacteria (DR-GNB) are a major health concern for hospitalized preterm neonates, globally. The aim of this study was to investigate the effect of a multi-strain probiotic on the incidence of rectal colonization with DR-GNB in preterm neonates. Methods: A double-blind, placebo-controlled, randomized clinical trial was conducted including 200 neonates, randomly allocated to a multi-strain probiotic (n = 100) or placebo (n = 100). Results: Fifteen percent of the neonates showed peri-rectal colonization with DR-GNB on the day of enrolment indicating probable maternal-to-neonate (vertical) bacterial transmission or environmental acquisition at time of delivery, with no difference between groups. Acquisition of further DR-GNB colonization was rapid, with an increase from 15% on the day enrolment to 77% by day 7 and 83% by day 14 of life. By day 7 (corresponding to early gut colonization), neonates in the probiotic group were 57% less likely to have peri-rectal DR-GNB colonization [OR: 0.43 (0.20-0.95); p = 0.04] and by day 14 (corresponding to late gut colonization), neonates in the probiotic group were 93% less likely to have peri-rectal DR-GNB colonization [OR: 0.07 (0.02-0.23); p < 0.001]. Conclusion: Hospitalized neonates showed substantial peri-rectal colonization with DR-GNB at enrolment and further rapid acquisition of DR-GNB in the first 2 weeks of life. The use of a multi-strain probiotic was effective in reducing early and late neonatal gut colonization with DR-GNB. Clinical Trial Registration: The trial was registered at the Pan African Clinical Trial Registry (PACTR202011513390736).

Effect of a Multi-Strain Probiotic on Growth and Time to Reach Full Feeds in Preterm Neonates.

Background: The main nutritional goal for premature neonates is to achieve a postnatal growth rate that the neonate would have experienced in utero. Postnatal growth failure is, however, very common in very and extremely low birth weight neonates. The use of probiotics shows promising results in reducing the time for full feeds, as well as in increased weight gain. The optimal probiotic strain has, however, not been elucidated. The aim of the present study was to evaluate the difference in the growth and time to reach full feeds between the two treatment arms, using LabinicTM as a multi-strain probiotic and a placebo. Methods: We conducted a double-blind, placebo-controlled, randomized clinical trial investigating the effect of a multi strain probiotic (LabinicTM) on various outcomes in preterm neonates. The results on the time to reach full feeds and the growth will be discussed in this paper. A probiotic or placebo was given once daily to the neonates for 28 days. Weight and feeding volume were measured daily, and length and head circumference were measured weekly. Results: The probiotic group reached full feeds earlier 8.7 days; ± 2.0 than the placebo group 9.7 days; ±4.3 (p = 0.04) and regained their birthweight earlier than the placebo group 11.5 days ± 6.3 vs. 13.3 days ± 6.3 (p = 0.06). From day 21 onwards, the probiotic group showed a significantly greater crude gain in weight (p < 0.001) than the placebo group (estimated difference between the two groups day 21: 56.7 g and at day 28: 83.7 g. There was a significant improvement observed in the weight Z-score change in the probiotic group over the 28-day period. Conclusion: The use of a multi-strain probiotic (LabinicTM) shows great potential as a low-cost, low-risk intervention in reducing the time to reach full feeds as well as shortening the time to regain birthweight. The probiotic had an additional beneficial impact on Z-score change in weight potentially decreasing post-natal growth restriction.

Effect of a Multi-Strain Probiotic on the Incidence and Severity of Necrotizing Enterocolitis and Feeding Intolerances in Preterm Neonates.

Background: Necrotizing enterocolitis (NEC) is a multifactorial disease, causing inflammation of the bowel. The exact root of NEC is still unknown, but a low weight and gestational age at birth are known causes. Furthermore, antibiotic use and abnormal bacterial colonization of the premature gut are possible causes. Premature neonates often experience feeding intolerances that disrupts the nutritional intake, leading to poor growth and neurodevelopmental impairment. Methods: We conducted a double-blind, placebo-controlled, randomized clinical trial to investigate the effect of a multi-strain probiotic formulation (LabinicTM) on the incidence and severity of NEC and feeding intolerances in preterm neonates. Results: There were five neonates in the placebo group who developed NEC (Stage 1A−3B), compared to no neonates in the probiotic group. Further, the use of probiotics showed a statistically significant reduction in the development of feeding intolerances, p < 0.001. Conclusion: A multi-strain probiotic is a safe and cost-effective way of preventing NEC and feeding intolerances in premature neonates.