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

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

Affiliations
  • 1Department of Pediatric Gastroenterology, Emma Children's Hospital, Academic Medical Center, Amsterdam, Netherlands.
  • 2KidZ Health Castle, UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium. yvan.vandenplas@uzbrussel.be

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.

Keyword

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

MeSH Terms

Constipation*
Defecation
Humans
Infant Formula
Infant*
Magnesium
Nutrition Therapy
Parents
Magnesium

Figure

  • Fig.1 Study participants. *One patient was withdrawn from the study prior to receiving treatment due to lactose intolerance; †Five patients in the control group were lost to follow-up after their day 8 visit due to the absence of improvement in their condition reported at their day 8 visit; ‡Two patients in the Mg-rich formula group were lost to follow-up after their day 8 visit as the patients were traveling.

  • Fig. 2 Complete responders, partial responders, and non-responders to treatment. Mg: magnesium.

  • Fig. 3 Mean pain score during defecation over time and by treatment. Mg: magnesium.


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