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Pediatr Gastroenterol Hepatol Nutr. 2019 May;22(3):270-281. doi: 10.5223/pghn.2019.22.3.270. Epub 2019 Apr 18.

The Magnesium-Rich Formula for Functional Constipation in Infants: a Randomized Comparator-Controlled Study.

Author information

1
Department of Pediatric Gastroenterology, Emma Children's Hospital, Academic Medical Center, Amsterdam, Netherlands.
2
KidZ Health Castle, UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium.

Abstract

Purpose:

To compare the effectiveness of the magnesium (Mg)-enriched formula vs. control formula in constipated infants.

Methods:

An open-label, interventional, and the comparator-controlled study was conducted to evaluate the effectiveness of the Mg-enriched formula in formula-fed infants ≤6 months old presenting with functional constipation according to modified Rome IV criteria. Infants were randomized 1:1 to intervention or control formula for 30 days. Parents recorded stool consistency (hard, normal, or watery) and frequency on days 1-7 and 23-29. Physicians recorded patient baseline characteristics and performed the clinical examination at the time of three patient visits (baseline, day 8, and 30).

Results:

Of the 286 recruited infants, 143 received the Mg-rich formula and 142 received the control formula. After 7 days, significantly more infants had stools with normal consistency with the Mg-rich formula compared to the infants fed with the control formula (81.8% vs. 41.1%; p<0.001). The number of infants passing one or more stools per day was increased at day 7 in the Mg-rich formula group (86.7% vs. 68.2%; p<0.001). At days 7 and 29, >25% of infants responded completely to the Mg-rich formula compared to <5% of infants fed with the control formula (p<0.001). Parents of infants in the Mg-rich formula group were very satisfied with the treatment (80.8% vs. 10.2%), with the majority willing to continue treatment after 30 days (97.9% vs. 52.6%; p<0.001).

Conclusion:

The Mg-rich formula significantly improved stool consistency and frequency compared to the control formula in constipated infants.

KEYWORDS:

Constipation; Defecation; Infant formula; Infants; Magnesium; Nutrition therapy

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