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Clinical Trial
. 2023 Dec 15;23(1):634.
doi: 10.1186/s12887-023-04426-y.

A cross-sectional study on stool- and gastrointestinal-related outcomes of Mexican infants consuming different formulae

Carlijn M Maasakkers  1 , Jeske H J Hageman  1 , Olivia Balcazar Muñoz  2 , Tomás Gómez Tamayo  3 , Andrés Blanco Montero  2 , Luis Gerardo Garza Lara  3 , Regina Flores-López  4 , Miriam Contreras Fernández  1 , Sofía Morán Ramos  4   5 , Tim T Lambers  6   7
Affiliations
Clinical Trial

A cross-sectional study on stool- and gastrointestinal-related outcomes of Mexican infants consuming different formulae

Carlijn M Maasakkers et al. BMC Pediatr. .

Abstract

Background: Immaturities present at birth, such as in the gut microbiome and digestive, nervous, and immune system, resolve with time. Nevertheless, this may result in mild digestive symptoms early in life, particularly in formula-fed infants. Formula composition and processing may impact this discomfort. This study therefore aimed to assess stool characteristics and gastrointestinal symptoms of healthy infants fed different formulae.

Methods: A multicenter, cross-sectional, observational trial was performed in Mexico between November 2019 and January 2022, where exclusively formula-fed infants (n = 342, aged 1-4 months) were studied in four groups based on their existing formula use. Feeding was continued per practice following label instructions. For 7 days, parents/caregivers were requested to record fecal characteristics, using the Amsterdam Infant Stool Scale, and rate gastrointestinal symptoms. Stool samples were collected to determine pH, dry matter content, and fecal calprotectin levels.

Results: Most infants had a soft/formed stool consistency, although odds for hard stools were different between groups. Gastrointestinal symptom scores revealed significant differences for burping and diarrhea, while other symptoms did not differ between groups. No significant differences between groups were found for stool frequency, dry matter content, and fecal pH. Although calprotectin was within the expected healthy ranges, significant differences among groups were seen. Furthermore, calprotectin significantly correlated with the severity of the gastrointestinal symptoms burping, flatulence, abdominal distension, and diarrhea.

Conclusions: Differences in stool characteristics and specific differences in gastrointestinal symptoms were observed between different formula brand users. This may potentially be explained by the different composition and processing of the formulae, although there are multiple factors that influence the assessed outcomes.

Trial registration: The study was registered in the Netherlands Trial Registry (NL7805), linked to https://trialsearch.who.int/ , on 11/06/2019.

Keywords: Digestive symptoms; Fecal characteristics; Infant formula; Infant nutrition.

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Conflict of interest statement

CMM, JHJH, MCF, and TTL are employed by FrieslandCampina. For the remaining authors, none is declared. This study was funded by FrieslandCampina, Amersfoort, The Netherlands.

Figures

Fig. 1
Fig. 1
Stool characteristics. Figure shows the percentages of Stool amount (1A), Stool consistency (1B), Stool color (1C) of the first stool each day grouped per IF brand from the ITT population, according to the Amsterdam Infant Stool Scale.
Fig. 2
Fig. 2
Calprotectin levels. 2A Median calprotectin levels with IQR per IF group. 2B Spearman’s rho correlation coefficients for calprotectin levels and gastrointestinal symptom severity scores. Green indicates a positive correlation meaning higher calprotectin levels correlated with a higher severity score, red indicates a negative correlation meaning higher calprotectin levels correlated with a lower severity score. *p < 0.05.
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References

    1. Lindquist S, Hernell O. Lipid digestion and absorption in early life: an update. Curr Opin Clin Nutr Metab Care [Internet]. 2010 [cited 2022 Nov 28];13(3):314–20. Available from: https://pubmed.ncbi.nlm.nih.gov/20179589/. - PubMed
    1. Bourlieu C, Ménard O, Bouzerzour K, Mandalari G, Macierzanka A, Mackie AR et al. Specificity of infant digestive conditions: some clues for developing relevant in vitro models. Crit Rev Food Sci Nutr [Internet]. 2014 [cited 2022 Jan 6];54(11):1427–57. Available from: https://pubmed.ncbi.nlm.nih.gov/24580539/. - PubMed
    1. Indrio F, Neu J, Pettoello-Mantovani M, Marchese F, Martini S, Salatto A et al. Development of the Gastrointestinal Tract in Newborns as a Challenge for an Appropriate Nutrition: A Narrative Review. Nutrients [Internet]. 2022 Apr 1 [cited 2023 Aug 25];14(7). Available from: https://pubmed.ncbi.nlm.nih.gov/35406018/. - PMC - PubMed
    1. Pina DI, Llach XB, Ariño-Armengol B, Iglesias VV. Prevalence and dietetic management of mild gastrointestinal disorders in milk-fed infants. World J Gastroenterol [Internet]. 2008 Jan 14 [cited 2023 Jan 16];14(2):248–54. Available from: https://pubmed.ncbi.nlm.nih.gov/18186563/. - PMC - PubMed
    1. Vandenplas Y, Hauser B, Salvatore S. Functional Gastrointestinal Disorders in Infancy: Impact on the Health of the Infant and Family. Pediatr Gastroenterol Hepatol Nutr [Internet]. 2019 May 1 [cited 2023 Aug 25];22(3):207. Available from: /pmc/articles/PMC6506429/. - PMC - PubMed

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