Oral Probiotics Prevent Necrotizing Enterocolitis in Very Low Birth Weight Preterm Infants: A Multicenter, Randomized, Controlled Trial
Abstract
OBJECTIVE. The goal was to investigate the efficacy of orally administered probiotics in preventing necrotizing enterocolitis for very low birth weight preterm infants. METHODS. A prospective, blinded, randomized, multicenter controlled trial was conducted at 7 NICUs in Taiwan, to evaluate the beneficial effects of probiotics in necrotizing enterocolitis among very low birth weight infants (birth weight: <1500 g). Very low birth weight infants who survived to start enteral feeding were eligible and were assigned randomly to 2 groups after parental informed consent was obtained. Infants in the study group were given Bifidobacterium bifidum and Lactobacillus acidophilus, added to breast milk or mixed feeding (breast milk and formula), twice daily for 6 weeks. Infants in the control group were fed with breast milk or mixed feeding. The clinicians caring for the infants were blinded to the group assignment. The primary outcome measurement was death or necrotizing enterocolitis (Bell's stage ≥2). RESULTS. Four hundred thirty-four infants were enrolled, 217 in the study group and 217 in the control group. The incidence of death or necrotizing enterocolitis (stage ≥2) was significantly lower in the study group (4 of 217 infants vs 20 of 217 infants). The incidence of necrotizing enterocolitis (stage ≥2) was lower in the study group, compared with the control group (4 of 217 infants vs 14 of 217 infants). No adverse effect, such as sepsis, flatulence, or diarrhea, was noted. CONCLUSION. Probiotics, in the form of Bifidobacterium and Lactobacillus, fed enterally to very low birth weight preterm infants for 6 weeks reduced the incidence of death or necrotizing enterocolitis.
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Different bifidobacteria species, mostly combined with St. thermophilus and/or Lb. acidophilus, have been shown to be effective in the prevention of necrotizing enterocolitis in children.
“as well as in the prevention of necrotizing enterocolitis in children [138,145,146]”
From Intestinal microbiota in health and disease: Role of bifidobacteria in gut homeostasis (2014) · cites this paper as [138]
A commercial product containing B. infantis reduces the incidence and severity of necrotizing enterocolitis in very-low-birth-weight infants and preterm infants.
“A commercial product containing a strain of B. infantis was able to reduce the incidence and severity of NEC in very-low-birth-weight infants (146) and in very-low-birth-weight preterm infants (147).”
From Bifidobacteria and Their Health-Promoting Effects (2017) · cites this paper as [147]
Randomised controlled trials support a protective role of probiotics against necrotising enterocolitis.
“randomised controlled trials support a protective role of probiotics.162,163”
From The microbiome and critical illness (2016) · cites this paper as [163]
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- Authors
- Lin, H.-C., Hsu, C.-H., Chen, H.-L., Chung, M.-Y., Hsu, J.-F., Lien, R.-I., Tsao, L.-Y., Chen, C.-H., & Su, B.-H.
- Affiliations
- China Medical University (TW)
- Mackay Memorial Hospital (TW)
- Kaohsiung Medical University (TW)
- Kaohsiung Chang Gung Memorial Hospital (TW)
- Chang Gung Children's Hospital (TW)
- Department of Pediatrics, Chang Gung Children's Hospital, Taoyuan, Taiwan
- Changhua Christian Hospital (TW)
- Taichung Veterans General Hospital (TW)
- Venue
- Pediatrics
- Publisher
- American Academy of Pediatrics (AAP)
- Published
- 2008-10-01
- Volume
- 122
- Issue
- 4
- Pages
- 693-700
- ISSN
- 0031-4005 (ISSN-L)
- 1098-4275
- OpenAlex
- W2120528311
- Cited by
- 506
- References
- 53
- Citations by year
- 2026: 4 · 2025: 4 · 2024: 13 · 2023: 24 · 2022: 22 · 2021: 20 · 2020: 18 · 2019: 26 · 2018: 17 · 2017: 34 · 2016: 34 · 2015: 38 · 2014: 45 · 2013: 59 · 2012: 47
- FWCI
- 32.12
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- PEDIATRICS (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Science Board
- Topics
- Health Sciences › Nursing › Nutrition and Dietetics › Infant Nutrition and Health
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Neonatal and Maternal Infections
- Keywords
- probiotics, necrotizing enterocolitis, very low birth weight infants, preterm infants, Bifidobacterium bifidum, Lactobacillus acidophilus, enteral nutrition, breast milk, mixed feeding, neonatal mortality, neonatal intensive care
- MeSH terms
- Administration, Oral, Bifidobacterium, Female, Follow-Up Studies, Humans, Infant, Newborn, Infant, Premature, Lactobacillus acidophilus, Male, Pilot Projects, Prospective Studies, Taiwan, Incidence, Survival Rate, Single-Blind Method, Treatment Outcome, Infant, Very Low Birth Weight, Probiotics, Enterocolitis, Necrotizing
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