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Published on: January 27, 2019
Prebiotic supplementation in full-term neonates: a systematic review of randomized controlled trials
Shripada Rao1, Ravisha Srinivasjois, Sanjay Patole
1Department of Neonatal Pediatrics, Princess Margaret Hospital for Children, Roberts Road, Subiaco, Perth, Western Australia 6008, Australia. Shripada.Rao@health.wa.gov.au
Insights
Prebiotic supplementation in infant formula is well tolerated and promotes beneficial gut bacteria in full-term neonates. This leads to softer stools similar to breastfed infants, though larger studies are needed for long-term effects.
Area of Science:
- Neonatal nutrition and gut microbiome research.
- Clinical trials and systematic reviews in pediatrics.
- Gastrointestinal health and infant development.
Background:
- Prebiotics are non-digestible food ingredients that beneficially affect the host by selectively stimulating the growth and/or activity of one or a limited number of bacteria in the colon.
- Understanding the impact of prebiotics on the gut microbiome and health outcomes in neonates is crucial for optimizing infant nutrition.
Purpose of the Study:
- To systematically review randomized controlled trials (RCTs) evaluating the efficacy and safety of prebiotic supplementation in full-term neonates.
- To assess the impact of prebiotics on gut microbiota composition, stool characteristics, and infant growth.
Main Methods:
- A systematic review of RCTs was conducted using multiple databases (Cochrane, MEDLINE, EMBASE, CINAHL) and conference proceedings.
- Eleven eligible trials (n=1459) compared formula milk with or without prebiotic supplementation, initiated within 28 days of birth for at least 2 weeks.
- Outcomes included stool colony counts, pH, consistency, frequency, anthropometry, and intolerance symptoms.
Main Results:
- Prebiotic supplementation significantly increased bifidobacteria counts and reduced stool pH.
- Infants receiving prebiotics had softer, more frequent stools, resembling those of breastfed infants.
- While weight gain was slightly improved, supplementation was generally well-tolerated, with one study noting increased diarrhea, irritability, and eczema.
Conclusions:
- Prebiotic-supplemented formula is safe and well-tolerated in full-term infants.
- It effectively modulates the gut microbiota, increasing beneficial bacteria and altering stool characteristics.
- Further large-scale trials with long-term follow-up are necessary to confirm sustained benefits.
Objective:
To systematically review randomized controlled trials evaluating the efficacy and safety of prebiotic supplementation in full-term neonates.
Data Sources:
Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and CINAHL databases and proceedings of relevant conferences.
Study Selection:
Eleven of 24 identified trials (n = 1459) were eligible for inclusion. Intervention Trials comparing formula milk supplemented with or without prebiotics, commenced at or before age 28 days and continued for 2 weeks or longer.
Main Outcome Measures:
Stool colony counts (bifidobacteria, lactobacilli, and pathogens), pH, consistency, frequency, anthropometry, and symptoms of intolerance.
Results:
Six trials reported significant increases and 2 reported a trend toward increases in bifidobacteria counts after supplementation. Meta-analysis estimated significant reduction in stool pH in infants who received prebiotic supplementation (weighted mean difference, -0.65; 95% confidence interval, -0.76 to -0.54; 6 trials). Infants who receive a supplement had slightly better weight gain than did controls (weighted mean difference, 1.07 g; 95% confidence interval, 0.14-1.99; 4 trials) with softer and frequent stools similar to breastfed infants. All but 1 trial reported that prebiotic supplementation was well tolerated. In that trial, diarrhea (18% vs 4%; P = .008), irritability (16% vs 4%; P = .03), and eczema (18% vs 7%; P = .046) were reported more frequently by parents of infants who received prebiotic supplements.
Conclusions:
Prebiotic-supplemented formula is well tolerated by full-term infants. It increases stool colony counts of bifidobacteria and lactobacilli and results in stools similar to those of breastfed neonates without affecting weight gain. Larger trials with long-term follow-up are needed to determine whether these short-term benefits are sustained.
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