Common gastrointestinal symptoms in healthy infants receiving goat milk-based formula or cow’s milk-based formula: a double-blind, randomized, controlled trial

Abstract Objective To assess common gastrointestinal symptoms in healthy Brazilian infants receiving goat milk-based formula (GMF) compared to cow’s milk-based formula (CMF). Methods We performed a 24-weeks double-blind, randomized, controlled study in Brazil, enrolling healthy infants from 3 to 12...

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Main Authors: P. Maximino, L. van Lee, Yvonne N. Meijer-Krommenhoek, L. van der Zee, H. da Costa Ribeiro Junior
Format: Article
Language:English
Published: BMC 2024-11-01
Series:BMC Pediatrics
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Online Access:https://doi.org/10.1186/s12887-024-05214-y
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author P. Maximino
L. van Lee
Yvonne N. Meijer-Krommenhoek
L. van der Zee
H. da Costa Ribeiro Junior
author_facet P. Maximino
L. van Lee
Yvonne N. Meijer-Krommenhoek
L. van der Zee
H. da Costa Ribeiro Junior
author_sort P. Maximino
collection DOAJ
description Abstract Objective To assess common gastrointestinal symptoms in healthy Brazilian infants receiving goat milk-based formula (GMF) compared to cow’s milk-based formula (CMF). Methods We performed a 24-weeks double-blind, randomized, controlled study in Brazil, enrolling healthy infants from 3 to 12 months of age. Primary outcome were the gastrointestinal (GI) symptoms stool consistency, regurgitation frequency and crying duration. Secondary outcomes were growth trajectories and hemoglobin levels. Repeated mixed models were used to compare outcomes variables between GMF and CMF groups, while adjusting for age at baseline. Results Fifty-six infants were recruited and randomly allocated in the GMF (n = 26) and the CMF (n = 30) group. Scores on all measured GI symptoms were low and similar among the groups throughout intervention period and improved over time. Average age- and sex-adjusted WHO z-scores of weight, length, head circumference, and weight-for-length were all within +/-1 SD and similar between groups, indicating adequate growth. Serum hemoglobin was 11.1 (SD 0.7) g/dL in infants fed GMF and 11.0 (SD 0.8) g/dL in infants fed CMF after the intervention and was similar between groups. Conclusion GMF was well tolerated, safe and supported adequate growth in infants. This was shown by the low occurrence of GI symptoms, adequate blood hemoglobin levels and adequate growth within WHO standards. Trial registration The clinical trial was approved by the ethics committee of the Federal University of Bahia under number CAAE06923319.5.0000.5577. The study was retrospectively registered in clinicaltrials.gov on 02/05/2024 under identifier NCT06395571.
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spelling doaj-art-bb5cc294c26240c29050d95e58dab6a92025-08-20T02:33:08ZengBMCBMC Pediatrics1471-24312024-11-012411810.1186/s12887-024-05214-yCommon gastrointestinal symptoms in healthy infants receiving goat milk-based formula or cow’s milk-based formula: a double-blind, randomized, controlled trialP. Maximino0L. van Lee1Yvonne N. Meijer-Krommenhoek2L. van der Zee3H. da Costa Ribeiro Junior4Ausnutria B.VAusnutria B.VAusnutria B.VAusnutria B.VHospital Professor Edgard Santos, Federal University of BahiaAbstract Objective To assess common gastrointestinal symptoms in healthy Brazilian infants receiving goat milk-based formula (GMF) compared to cow’s milk-based formula (CMF). Methods We performed a 24-weeks double-blind, randomized, controlled study in Brazil, enrolling healthy infants from 3 to 12 months of age. Primary outcome were the gastrointestinal (GI) symptoms stool consistency, regurgitation frequency and crying duration. Secondary outcomes were growth trajectories and hemoglobin levels. Repeated mixed models were used to compare outcomes variables between GMF and CMF groups, while adjusting for age at baseline. Results Fifty-six infants were recruited and randomly allocated in the GMF (n = 26) and the CMF (n = 30) group. Scores on all measured GI symptoms were low and similar among the groups throughout intervention period and improved over time. Average age- and sex-adjusted WHO z-scores of weight, length, head circumference, and weight-for-length were all within +/-1 SD and similar between groups, indicating adequate growth. Serum hemoglobin was 11.1 (SD 0.7) g/dL in infants fed GMF and 11.0 (SD 0.8) g/dL in infants fed CMF after the intervention and was similar between groups. Conclusion GMF was well tolerated, safe and supported adequate growth in infants. This was shown by the low occurrence of GI symptoms, adequate blood hemoglobin levels and adequate growth within WHO standards. Trial registration The clinical trial was approved by the ethics committee of the Federal University of Bahia under number CAAE06923319.5.0000.5577. The study was retrospectively registered in clinicaltrials.gov on 02/05/2024 under identifier NCT06395571.https://doi.org/10.1186/s12887-024-05214-yInfant formulaGoat milk-based infant formulaBreast-milk substitutesInfant Nutrition
spellingShingle P. Maximino
L. van Lee
Yvonne N. Meijer-Krommenhoek
L. van der Zee
H. da Costa Ribeiro Junior
Common gastrointestinal symptoms in healthy infants receiving goat milk-based formula or cow’s milk-based formula: a double-blind, randomized, controlled trial
BMC Pediatrics
Infant formula
Goat milk-based infant formula
Breast-milk substitutes
Infant Nutrition
title Common gastrointestinal symptoms in healthy infants receiving goat milk-based formula or cow’s milk-based formula: a double-blind, randomized, controlled trial
title_full Common gastrointestinal symptoms in healthy infants receiving goat milk-based formula or cow’s milk-based formula: a double-blind, randomized, controlled trial
title_fullStr Common gastrointestinal symptoms in healthy infants receiving goat milk-based formula or cow’s milk-based formula: a double-blind, randomized, controlled trial
title_full_unstemmed Common gastrointestinal symptoms in healthy infants receiving goat milk-based formula or cow’s milk-based formula: a double-blind, randomized, controlled trial
title_short Common gastrointestinal symptoms in healthy infants receiving goat milk-based formula or cow’s milk-based formula: a double-blind, randomized, controlled trial
title_sort common gastrointestinal symptoms in healthy infants receiving goat milk based formula or cow s milk based formula a double blind randomized controlled trial
topic Infant formula
Goat milk-based infant formula
Breast-milk substitutes
Infant Nutrition
url https://doi.org/10.1186/s12887-024-05214-y
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