A cross-sectional study on stool- and gastrointestinal-related outcomes of Mexican infants consuming different formulae.

BACKGROUND: Immaturities present at birth, such as in the gut microbiome and digestive, nervous, and immune system, resolve with time. Nevertheless, this may result in mild digestive symptoms early in life, particularly in formula-fed infants. Formula composition and processing may impact this discomfort. This study therefore aimed to assess stool characteristics and gastrointestinal symptoms of healthy infants fed different formulae. METHODS: A multicenter, cross-sectional, observational trial was performed in Mexico between November 2019 and January 2022, where exclusively formula-fed infants (n = 342, aged 1-4 months) were studied in four groups based on their existing formula use. Feeding was continued per practice following label instructions. For 7 days, parents/caregivers were requested to record fecal characteristics, using the Amsterdam Infant Stool Scale, and rate gastrointestinal symptoms. Stool samples were collected to determine pH, dry matter content, and fecal calprotectin levels. RESULTS: Most infants had a soft/formed stool consistency, although odds for hard stools were different between groups. Gastrointestinal symptom scores revealed significant differences for burping and diarrhea, while other symptoms did not differ between groups. No significant differences between groups were found for stool frequency, dry matter content, and fecal pH. Although calprotectin was within the expected healthy ranges, significant differences among groups were seen. Furthermore, calprotectin significantly correlated with the severity of the gastrointestinal symptoms burping, flatulence, abdominal distension, and diarrhea. CONCLUSIONS: Differences in stool characteristics and specific differences in gastrointestinal symptoms were observed between different formula brand users. This may potentially be explained by the different composition and processing of the formulae, although there are multiple factors that influence the assessed outcomes. TRIAL REGISTRATION: The study was registered in the Netherlands Trial Registry (NL7805), linked to https://trialsearch.who.int/ , on 11/06/2019.

Efficacy and Safety of the Adjuvant Use of Probiotic Bacillus clausii Strains in Pediatric Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Study.

OBJECTIVES: Current irritable bowel syndrome (IBS) treatments have limited efficacy and probiotics like Bacillus clausii (B. clausii) were found to be effective in the management of several gastrointestinal disorders. This phase III trial assessed the efficacy and safety of adding B. clausii (four strains: O/C, N/R, SIN, T), versus placebo, to conventional treatment of pediatric IBS in Mexico. METHODS: Patients aged 6-17 years 11 months with IBS (Rome IV) for at least 2 months were randomized to receive either B. clausii (oral suspension, total dose 4 billion spores/day) or placebo once daily for 8 weeks. All patients also received conventional treatment. The primary endpoint was the difference in the proportion of patients with clinical improvements at Week 8 (Global Assessment Questions [GAQ]). Secondary endpoints included responders by Subject's Global Assessment of Relief for Children with IBS (SGARC); number/consistency of stools; abdominal distention/bloating; abdominal pain/intensity; and IBS behavior. RESULTS: 73.6% (95% confidence interval [CI] 67.3-80.0; B. clausii n = 129) and 78.5% (95% CI 72.5-84.4; placebo n = 130) of patients had symptom improvement (p = 0.8182). For Week 8 SGARC, 19.2% (B. clausii) and 20.9% (placebo) reported complete symptom relief. Stool evaluations, bloating, abdominal pain/intensity, and IBS behavior were similar between groups. Both treatments were well tolerated. CONCLUSION: No significant differences in efficacy between B. clausii and placebo were demonstrated in addition to conventional treatment. The sample size calculation was based on an expected placebo/conventional treatment response of 30-40%. However, the actual treatment response observed was 80% and, thus, a study with larger population would be warranted. In addition, this study was conducted during the COVID-19 pandemic, when such controlled social conditions may have resulted in better diet, greater family stability, less psychological stress, and lower risk of infections exacerbating IBS, thereby improving symptoms in both groups. EUDRACT NUMBER: 2018-004519-31.

Complementary feeding practices in Mexican healthy infants: How close are they to the current guidelines? / Prácticas de alimentación complementaria en lactantes sanos en México: ¿qué tan apegadas se encuentran al consenso actual?

Abstract Background: The foundations for the growth and optimal development of every human being are laid in the first 2 years of life. Exclusive breastfeeding (EBF) up to 6 months of age and the introduction of complementary feeding (CF) from this age are considered the preventive interventions with the most significant impact on a child's life. The objective of this study was to determine if pediatricians base their recommendations by following the Guidelines for CF in Healthy Infants (GCFHI) and if mothers have any awareness and knowledge of these recommendations. Methods: Surveys based on the GCFHI were conducted in a group of mothers (n = 377) and pediatricians (n = 104) living in Mexico. Results: Not all pediatricians recommended the EBF, and 76% recommended infant formula before 6 months of age. Regarding mothers, 76.9% practiced the EBF for the first 6 months. Vegetables were the leading starting food of CF suggested by pediatricians and mothers (87% and 91%, respectively), contrasting with food sources of iron (44%), which are the foods of choice according to the GCFHI. The practices performed by the mothers were statistically different from the recommendations of the pediatricians. Conclusions: The results reflect a lack of updating regarding CF. It is imperative to reinforce efforts to maintain the EBF for 6 months and to continue it together with the CF, as well as to promote the beginning of CF based on macro- and micro-nutrients.

Resumen Introducción: En los primeros dos años de vida se crean las bases para el crecimiento y desarrollo óptimo de todo ser humano. La lactancia materna exclusiva (LME) hasta los 6 meses de edad y la introducción de alimentación complementaria (AC) a partir de esta edad están consideradas como las intervenciones preventivas de mayor impacto en la vida de un niño. El presente trabajo evalúa en qué medida los pediatras basan sus recomendaciones en el Consenso para las prácticas de alimentación complementaria en lactantes sanos (CALCS) y si las madres están familiarizadas con estas recomendaciones. Métodos: Se realizaron encuestas para madres (n = 377) y pediatras (n = 104) residentes en México basadas en el CALCS. Resultados: Se detectó que no todos los pediatras recomendaron la LME, y el 76% la complementa con sucedáneos de la leche materna antes de los 6 meses. El 76.9% de las madres practicaron la LME por 6 meses. Las verduras fueron el principal alimento de inicio de AC sugerido por pediatras y madres (87% y 91%, respectivamente), lo que contrasta con alimentos fuente de hierro (44%) que según el CALCS son los alimentos de elección. Las prácticas de las madres tuvieron diferencias significativas con las recomendaciones de los pediatras. Conclusiones: Hay una falta de formación y actualización en esta materia. Es imperativo reforzar los esfuerzos para mantener la LME por 6 meses y continuarla junto con la AC, así como promover el inicio de la AC con base en los macro y micronutrientes.

Complementary feeding practices in Mexican healthy infants: How close are they to the current guidelines?

Background: The foundations for the growth and optimal development of every human being are laid in the first 2 years of life. Exclusive breastfeeding (EBF) up to 6 months of age and the introduction of complementary feeding (CF) from this age are considered the preventive interventions with the most significant impact on a child's life. The objective of this study was to determine if pediatricians base their recommendations by following the Guidelines for CF in Healthy Infants (GCFHI) and if mothers have any awareness and knowledge of these recommendations. Methods: Surveys based on the GCFHI were conducted in a group of mothers (n = 377) and pediatricians (n = 104) living in Mexico. Results: Not all pediatricians recommended the EBF, and 76% recommended infant formula before 6 months of age. Regarding mothers, 76.9% practiced the EBF for the first 6 months. Vegetables were the leading starting food of CF suggested by pediatricians and mothers (87% and 91%, respectively), contrasting with food sources of iron (44%), which are the foods of choice according to the GCFHI. The practices performed by the mothers were statistically different from the recommendations of the pediatricians. Conclusions: The results reflect a lack of updating regarding CF. It is imperative to reinforce efforts to maintain the EBF for 6 months and to continue it together with the CF, as well as to promote the beginning of CF based on macro- and micro-nutrients.

Introducción: En los primeros dos años de vida se crean las bases para el crecimiento y desarrollo óptimo de todo ser humano. La lactancia materna exclusiva (LME) hasta los 6 meses de edad y la introducción de alimentación complementaria (AC) a partir de esta edad están consideradas como las intervenciones preventivas de mayor impacto en la vida de un niño. El presente trabajo evalúa en qué medida los pediatras basan sus recomendaciones en el Consenso para las prácticas de alimentación complementaria en lactantes sanos (CALCS) y si las madres están familiarizadas con estas recomendaciones. Métodos: Se realizaron encuestas para madres (n = 377) y pediatras (n = 104) residentes en México basadas en el CALCS. Resultados: : Se detectó que no todos los pediatras recomendaron la LME, y el 76% la complementa con sucedáneos de la leche materna antes de los 6 meses. El 76.9% de las madres practicaron la LME por 6 meses. Las verduras fueron el principal alimento de inicio de AC sugerido por pediatras y madres (87% y 91%, respectivamente), lo que contrasta con alimentos fuente de hierro (44%) que según el CALCS son los alimentos de elección. Las prácticas de las madres tuvieron diferencias significativas con las recomendaciones de los pediatras. Conclusiones: Hay una falta de formación y actualización en esta materia. Es imperativo reforzar los esfuerzos para mantener la LME por 6 meses y continuarla junto con la AC, así como promover el inicio de la AC con base en los macro y micronutrientes.

[Clinical conditions at hospitalization and its relation with admission to pediatric intensive care unit]. / Condición clínica a la hospitalización y relación con el ingreso a terapia intensiva pediátrica.

BACKGROUND: The admission to a pediatric intensive care unit (PICU) depends on several factors, but the chances of recovery of the patient are the main cause. Most of the patients are admitted from urgency or surgery room, and a minority from hospitalization areas. The aim of this study was to find the differences between the clinical conditions at the time of hospitalization and when the patients were transferred to PICU. METHODS: Retrospective cohort study of 78 children under 17 years of age with a hospital stay before their admission to the PICU. We measured respiratory, cardiovascular, neurological and metabolic conditions, when patients were admitted at hospitalization, and also for their admission to PICU. A evaluation of Pediatric Index of Mortality at the time of the admission to the PICU was applied. We analyzed the differences between those admitted before 24 hours of stay and those after 24 hours. RESULTS: 44 patients (56.4 %) were less than 24 hours in a hospital ward and they had more unstable symptoms since their admission; most of them were previously healthy infants with acute diseases or severe injuries. In those patients with more than 24 hours of stay (43.6 %), and with better conditions at admission, the decision was related to complications with a former disease (23.5 % oncologic patients). CONCLUSIONS: Medical conditions at the time of admission to a hospital could alert the medical staff for the early decision to transfer a patient to the PICU. Health history or previous diseases are important.

INTRODUCCIÓN: el ingreso a la unidad de cuidados intensivos pediátricos (UTIP) depende de varios factores, pero el principal es la posibilidad de recuperación del paciente. La mayoría de los pacientes ingresa desde urgencias o el quirófano, sin embargo, un grupo menor es trasladado de las salas de hospitalización. El objetivo de esta investigación fue comparar las condiciones clínicas de niños que ingresaron a la sala de hospitalización con las que presentaron al ser traslados a la UTIP. MÉTODOS: estudio de cohorte retrospectiva de 78 pacientes menores de 17 años de edad con estancia en la sala de hospitalización antes de ingresar a terapia intensiva. Se evaluaron las condiciones respiratorias, cardiovasculares, neurológicas, hidroelectrolíticas y metabólicas al ingreso a la sala y a la UTIP; así como la calificación del Índice de Mortalidad Pediátrica y las diferencias entre las estancias menores y mayores de 24 horas. RESULTADOS: 44 pacientes (56.4 %) estuvieron menos de 24 horas en la sala de hospitalización y desde su ingreso tuvieron más datos de inestabilidad; en la mayoría se trató de lactantes previamente sanos con enfermedades agudas o traumatismos severos. En los niños que permanecieron 24 o más horas de estancia (43.6 %), la decisión se relacionó con deterioro por complicaciones de enfermedades previas (23.5 % oncológicos), con mayor estabilidad clínica al ingreso. CONCLUSIONES: las condiciones de un niño al ingreso a una sala de hospitalización pudieran alertar para trasladarlo tempranamente a terapia intensiva. Los antecedentes de salud o enfermedad previa son importantes.

[Mexican guidelines on the diagnosis and treatment of urticaria]. / Guía Mexicana para el Diagnóstico y el Tratamiento de la Urticaria.

BACKGROUND: Urticaria is a disease that a fifth of the population shallsuffer once in a lifetime. Recent clinical guidelines have proposed some fundamental changes in the diagnosis and treatment of urticaria, making the development of a national, multidisciplinary guideline, with wide acceptability among different professional groups -both specialists and primary health care workers-, necessary in Mexico. MATERIAL AND METHOD: Internationally recognized tools for guidelinedevelopment were used. An interdisciplinary group of clinical experts (some of them knowledgeable in methodology of guideline development) determined the objectives and scope of the Evidence Based Clinical Practice Guideline with SCOPE. It was decided to adapt and transculturize international guidelines on the diagnosis and treatment of urticaria. With AGREE-II three high-quality guidelines (Zuberbier 2014, Sánchez-Borges 2012, Powell 2007) were selected to function as basic guidelines (BG). A set of Clinical Questions was formulated that lead to recommendations/suggestions, based on these BG, taking into account the cultural and economic background of Mexico, according to GRADE recommendation development. RESULTS: By a formal process of discussion and voting during several working-sessions, experts and first level healthcare physicians determined the wording of the final guideline, taking particularly care of developing a document, adjusted to the reality, values and preferences of the Mexican patients. The use of oral second generation, non-sedating antihistamines as first line treatment is emphasized. CONCLUSION: This document is an Evidence Based Clinical Practice Guideline for the diagnosis and treatment of acute and chronic urticaria, based on three, high quality, international guidelines. It was developed by a multidisciplinary group. Tables and algorithms make the guideline user-friendly for both, first line health care physicians and specialists.

Antecedentes: la urticaria es una enfermedad que padece una quinta parte de la población en algún momento de su vida. Las guías internacionales recientes han propuesto unos cambios de fondo en su diagnóstico y tratamiento, por lo que había la necesidad de crear una guía nacional y multidisciplinaria, con base amplia en los gremios de especialistas y médicos de primer contacto en México. Material y método: un grupo interdisciplinario de expertos clínicos y algunos expertos en metodología determinó los objetivos y alcances de la Guía de Práctica Clínica Basada en Evidencia con el instrumento SCOPE. Se decidió llevar a cabo la adaptación y transculturización de guías internacionales para el diagnóstico y tratamiento de urticaria. Con el instrumento AGREE-II se seleccionaron las tres guías de alta calidad, como guías base (Zuberbier 2014, Sánchez-Borges 2012, Powell 2007) para formular y contestar la preguntas clínicas clave, en el contexto cultural y económico mexicano, según el método de desarrollo de recomendaciones GRADE. Resultados: mediante un proceso formal de discusión y votación durante varias juntas de expertos, se terminó la redacción de la forma final de la guía, con especial cuidado de lograr un ajuste a las realidades, valores y preferencias de los pacientes de México. Se hace hincapié en la administración de antihistamínicos vía oral de segunda generación, como tratamiento de primera elección. Conclusión: este documento es una Guía de Práctica Clínica Basada en Evidencia para el diagnóstico y tratamiento de urticaria aguda y crónica, basada en tres guías internacionales de alta calidad. Se desarrolló por un grupo multidisciplinario. Los cuadros y algoritmos hacen a la guía amigable para su uso por médicos de primer contacto y por especialistas.