TY - JOUR
T1 - The Magnesium-rich formula for functional constipation in infants: A randomized comparator-controlled study
AU - Benninga, Marc A.
AU - Vandenplas, Yvan
AU - Bassil, Ziad
AU - Sokhn, Maroun
AU - Sayad, Alain
AU - Semaan, Firas
AU - Eid, Bassam
AU - Cheriathu, Jenny
AU - Abdallah, Ayman
AU - Ghauhar, Shahid
AU - el Sabea, Hassan
AU - Al Mahmoud, Ahmed Abdulattif
AU - Sathyanarayanan, Varadarajulu
AU - Shalabi, Zuhair Abbas
AU - Rizk, Tamer Mohamed Gaber
AU - Fawzi, Eman
AU - Ammar, Tarek Galal
AU - Farid, Waleed
AU - Emara, Ihab
AU - Kamalo, Mohamad
AU - el Daif, Saleh
AU - MENA Infant Constipation Study Group, null
PY - 2019/5/1
Y1 - 2019/5/1
N2 - 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.
AB - 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.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85066156913&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/31110960
U2 - https://doi.org/10.5223/pghn.2019.22.3.270
DO - https://doi.org/10.5223/pghn.2019.22.3.270
M3 - Article
C2 - 31110960
SN - 2234-8646
VL - 22
SP - 270
EP - 281
JO - Pediatric gastroenterology, hepatology and nutrition
JF - Pediatric gastroenterology, hepatology and nutrition
IS - 3
ER -