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.
Constipation ; Defecation ; Humans ; Infant Formula ; Infant ; Magnesium ; Nutrition Therapy ; Parents

No abstract available.
Child* ; Gastrointestinal Diseases* ; Humans ; Obesity*

Functional gastrointestinal disorders (FGIDs) are common worldwide and cover a wide range of disorders attributable to the gastrointestinal tract that cannot be explained by structural or biochemical abnormalities. The diagnosis of these disorders relies on the symptom-based Rome criteria. In 2016 the Rome criteria were revised for infants/toddlers and for children and adolescents. In this review, we discuss the novel Rome IV criteria for infants and toddlers. The criteria for infant colic were drastically changed, whereas only minor changes were made for regurgitation, cyclic vomiting syndrome, functional diarrhea, infant dyschezia and functional constipation. In addition to this, the new Rome IV discusses underlying mechanisms of pain in infants and toddlers, including the neuro-development of nociceptive and pain pathways, the various factors that are involved in pain experience, and methods of pain assessment in infants and toddlers is essential for the clinician who encounters functional pain in this age group. Overall, the Rome IV criteria have become more distinctive for all disorders in order to improve the process of diagnosing pediatric FGIDs.
Adolescent ; Child ; Colic ; Constipation ; Diagnosis ; Diarrhea ; Gastrointestinal Diseases* ; Gastrointestinal Tract ; Humans ; Infant* ; Pain Measurement ; Vomiting

Background/Aims: To investigate the intra-rater (test-retest) reliability of the diagnosis of functional gastrointestinal disorders (FGIDs) as measured by the Questionnaire on Pediatric Functional Gastrointestinal Disorders, Rome IV version (QPGS-IV) in children. Methods: A prospective cohort study was conducted in a public school in Cali, Colombia. Children and adolescents between 11 and 18 years of age were given the self-report Spanish version of the QPGS-IV at day 0 (baseline) and at day 2 (48 hours later). Results: The study protocol was completed by 215 children, of which 97 (45%) were excluded from analysis due to the inability to follow the questionnaire’s instructions. The final analysis included data of 118 children (mean age 15.0 ± SD 1.8 years old, 58.5% boys). The most common diagnoses were functional dyspepsia, functional constipation, and irritable bowel syndrome. We found a moderate intra-rater reliability (κ = 0.61-0.65) for diagnosing an FGID in general, a functional abdominal pain disorder, and the diagnosis of functional dyspepsia. We found a weak intra-rater reliability (κ = 0.46-0.54) for diagnosing a functional defecation disorder, functional constipation, irritable bowel syndrome, and the postprandial distress syndrome subtype of functional dyspepsia. Conclusions Our study shows that a large proportion of children cannot adequately complete the QPGS-IV and that the intra-rater reliability among those who did adequately follow the instructions is moderate. We advise to test the children’s understanding of the instructions prior to completion of questionnaires and recommend to not rely exclusively on a self-reported questionnaire to select, recruit, or evaluate pediatric patients for FGIDs for research purposes.

Background/Aims: To investigate the intra-rater (test-retest) reliability of the diagnosis of functional gastrointestinal disorders (FGIDs) as measured by the Questionnaire on Pediatric Functional Gastrointestinal Disorders, Rome IV version (QPGS-IV) in children. Methods: A prospective cohort study was conducted in a public school in Cali, Colombia. Children and adolescents between 11 and 18 years of age were given the self-report Spanish version of the QPGS-IV at day 0 (baseline) and at day 2 (48 hours later). Results: The study protocol was completed by 215 children, of which 97 (45%) were excluded from analysis due to the inability to follow the questionnaire’s instructions. The final analysis included data of 118 children (mean age 15.0 ± SD 1.8 years old, 58.5% boys). The most common diagnoses were functional dyspepsia, functional constipation, and irritable bowel syndrome. We found a moderate intra-rater reliability (κ = 0.61-0.65) for diagnosing an FGID in general, a functional abdominal pain disorder, and the diagnosis of functional dyspepsia. We found a weak intra-rater reliability (κ = 0.46-0.54) for diagnosing a functional defecation disorder, functional constipation, irritable bowel syndrome, and the postprandial distress syndrome subtype of functional dyspepsia. Conclusions Our study shows that a large proportion of children cannot adequately complete the QPGS-IV and that the intra-rater reliability among those who did adequately follow the instructions is moderate. We advise to test the children’s understanding of the instructions prior to completion of questionnaires and recommend to not rely exclusively on a self-reported questionnaire to select, recruit, or evaluate pediatric patients for FGIDs for research purposes.

Background/Aims: To assess the effectiveness and feasibility of a brief session of hypnosis to reduce distress in children with functional constipationundergoing anorectal manometry (ARM). Methods: A partially-blinded randomized controlled pilot trial was conducted in children 4-18 years old scheduled for ARM. Children were randomized to receive a brief session of hypnosis prior to ARM or standard care. Non-blinded and blinded observers rated the child’s level of distress using the Observation Scale of Behavioral Distress and a 4-point-Likert scale, respectively. Differences between groupswere analyzed using Fisher’s exact test or Mann-Whitney U test as appropriate. Results: Data from 32 children (15 hypnosis and 17 standard care) were analyzed. Prior to insertion of the catheter, the observed mean levels of distress were lower in the hypnosis group according to both the non-blinded observer (median 0.0 [interquartile range {IQR} 0.0-0.3] vs 1.4 [IQR 0.3-2.4]; P = 0.009) and the blinded observer (median 0.0 [IQR 0.0-0.0] vs 0.5 [IQR 0.0-1.0]; P = 0.044). During ARM, observed and reported levels of distress did not differ significantly. In the hypnosis group, 92.9% of parents and childrenreported that hypnosis helped the child to relax. There were no significant differences in resting pressure, squeeze pressure, or duration of the procedure between both groups. Conclusion A brief session of hypnosis for children before ARM is an easily incorporable intervention that lowers distress levels prior to theprocedure and is positively perceived by children and parents.