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CLINICAL TRIAL article

Front. Pediatr.
Sec. Pediatric Gastroenterology, Hepatology and Nutrition
Volume 12 - 2024 | doi: 10.3389/fped.2024.1456607

Infant formula with added Lacticaseibacillus rhamnosus GG supported adequate growth and was well tolerated in healthy term infants: Randomized controlled trial

Provisionally accepted
Carol L. Berseth Carol L. Berseth 1Michael Yeiser Michael Yeiser 2Cheryl L. Harris Cheryl L. Harris 1Jennifer Kinnaman Jennifer Kinnaman 3Victoria Lappin Victoria Lappin 4Jennifer L. Wampler Jennifer L. Wampler 1,5*Weihong Zhuang Weihong Zhuang 1Jon Vanderhoof Jon Vanderhoof 6
  • 1 Medical Sciences, Reckitt | Mead Johnson Nutrition, Evansville, IN 47721, United States
  • 2 Owensboro Pediatrics, 2200 E Parrish Ave, Bldg B, Suite 101, Owensboro, Ky 42303, United States
  • 3 Nutrition Sciences, Reckitt / Mead Johnson Nutrition Institute, Evansville, IN 47721, United States
  • 4 Clinical Research, Research & Development, Reckitt, Dansom Lane, Hull HU8 7DS, United Kingdom
  • 5 Mead Johnson (United States), Glenview, United States
  • 6 Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, United States

The final, formatted version of the article will be published soon.

    Lacticaseibacillus rhamnosus GG (LGG) is a well-studied prebiotic with a history of safe use. In this double-blind, prospective study, growth and tolerance were evaluated in healthy term infants randomized to: marketed, routine intact cow's milk protein-based formula (Control, n=172) or a similar investigational formula with added LGG (INV-LGG, n=179; 10 6 CFU LGG®/g powder) from 14 to 120 days of age. Anthropometrics, stool characteristics, fussiness, and gassiness were evaluated through Day 120. Medically confirmed adverse events were recorded throughout the study period. The primary outcome was rate of weight gain from Day 14-120. Of 351 infants enrolled, 275 completed (Control, n=131; INV-LGG, n=144). No significant group differences in rate of weight gain from Day 14-120 were detected. Study formula acceptance and tolerance was good with no significant differences in study discontinuation due to study formula or parentreported gassiness, stool frequency, or stool consistency; however mean fussiness relative to normal was significantly lower for INV-LGG vs Control at Days 60 and 90. In healthy term infants, a routine intact cow's milk protein-based formula with added LGG supported adequate growth and was well tolerated. Further studies are needed to evaluate potential benefits for fussiness and efficacy outcomes.

    Keywords: term infant 1, pediatric nutrition 2, infant formula 3, Lacticaseibacillus rhamnosus GG 4, healthy growth 5

    Received: 28 Jun 2024; Accepted: 24 Sep 2024.

    Copyright: © 2024 Berseth, Yeiser, Harris, Kinnaman, Lappin, Wampler, Zhuang and Vanderhoof. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Jennifer L. Wampler, Mead Johnson (United States), Glenview, United States

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.