Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age.

BACKGROUND: The safety, reactogenicity, immunogenicity, and efficacy of the mRNA-1273 coronavirus disease 2019 (Covid-19) vaccine in young children are unknown. METHODS: Part 1 of this ongoing phase 2-3 trial was open label for dose selection; part 2 was an observer-blinded, placebo-controlled evaluation of the selected dose. In part 2, we randomly assigned young children (6 months to 5 years of age) in a 3:1 ratio to receive two 25-µg injections of mRNA-1273 or placebo, administered 28 days apart. The primary objectives were to evaluate the safety and reactogenicity of the vaccine and to determine whether the immune response in these children was noninferior to that in young adults (18 to 25 years of age) in a related phase 3 trial. Secondary objectives were to determine the incidences of Covid-19 and severe acute respiratory syndrome coronavirus 2 infection after administration of mRNA-1273 or placebo. RESULTS: On the basis of safety and immunogenicity results in part 1 of the trial, the 25-µg dose was evaluated in part 2. In part 2, 3040 children 2 to 5 years of age and 1762 children 6 to 23 months of age were randomly assigned to receive two 25-µg injections of mRNA-1273; 1008 children 2 to 5 years of age and 593 children 6 to 23 months of age were randomly assigned to receive placebo. The median duration of follow-up after the second injection was 71 days in the 2-to-5-year-old cohort and 68 days in the 6-to-23-month-old cohort. Adverse events were mainly low-grade and transient, and no new safety concerns were identified. At day 57, neutralizing antibody geometric mean concentrations were 1410 (95% confidence interval [CI], 1272 to 1563) among 2-to-5-year-olds and 1781 (95% CI, 1616 to 1962) among 6-to-23-month-olds, as compared with 1391 (95% CI, 1263 to 1531) among young adults, who had received 100-µg injections of mRNA-1273, findings that met the noninferiority criteria for immune responses for both age cohorts. The estimated vaccine efficacy against Covid-19 was 36.8% (95% CI, 12.5 to 54.0) among 2-to-5-year-olds and 50.6% (95% CI, 21.4 to 68.6) among 6-to-23-month-olds, at a time when B.1.1.529 (omicron) was the predominant circulating variant. CONCLUSIONS: Two 25-µg doses of the mRNA-1273 vaccine were found to be safe in children 6 months to 5 years of age and elicited immune responses that were noninferior to those in young adults. (Funded by the Biomedical Advanced Research and Development Authority and National Institute of Allergy and Infectious Diseases; KidCOVE ClinicalTrials.gov number, NCT04796896.).

The impact of Moringa oleifera leaf supplementation on human and animal nutrition, growth, and milk production: A systematic review.

Childhood undernutrition contributes to up to 45% of deaths in children under age 5. Moringa oleifera (moringa) leaves are nutrient dense and promote breastmilk production. We performed a systematic review assessing the impact of moringa leaf supplementation in humans and animals on the outcomes of iron, vitamin A status, the measures of growth, and/or breastmilk production. Our inclusion/exclusion criteria were as follows; inclusion: quantitative primary data assessing the effect of moringa leaf supplementation on humans or animals including any of the outcomes defined earlier with no exclusion for geography, age, or language. Exclusion: full text not available. Our search yielded 148 unique studies; among them, 33 were included (seven human studies and 26 animal studies). Quality assessment by Effective Public Health Practice Project guidelines was strong for one study and moderate for all other studies. In humans, moringa at higher (14-30 g/day) not lower (<10 g/day) doses improved hemoglobin (Hgb) in children with iron deficiency anemia, improved Hgb and vitamin A status in postmenopausal women, and increased BMI in HIV+ underweight adults. Moringa (0.5 g/day) also increased breastmilk volumes. In animals, moringa increased milk production in two of three studies, inconsistently affected growth, and had no effect on iron status. Evidence on moringa supplementation's utility is limited but promising. Larger, more rigorous trials are needed to characterize its impact.

Day clinic vs. hospital care of pneumonia and severe malnutrition in children under five: a randomised trial.

OBJECTIVES: To evaluate the clinical outcomes and costs of managing pneumonia and severe malnutrition in a day clinic (DC) management model (outpatient) vs. hospital care (inpatient). METHODS: Randomised clinical trial where children aged 2 months to 5 years with pneumonia and severe malnutrition were randomly allocated to DC or inpatient hospital care. We used block randomisation of variable length from 8 to 20 and produced computer-generated random numbers that were assigned to one of the two interventions. Successful management was defined as resolution of clinical signs of pneumonia and being discharged from the model of care (DC or hospital) without need for referral to a hospital (DC), or referral to another hospital. All the children in both DC and hospital received intramuscular ceftriaxone, daily nutrition support and micronutrients. RESULTS: Four hundred and seventy children were randomly assigned to either DC or hospital care. Successful management was achieved for 184 of 235 (78.3%) by DC alone, vs. 201 of 235 (85.5%) by hospital inpatient care [RR (95% CI) = 0.79 (0.65-0.97), P = 0.02]. During 6 months of follow-up, 30/235 (12.8%) in the DC group and 36/235 (15.3%) required readmission to hospital in the hospital care group [RR (95% CI) = 0.89 (0.67-1.18), P = 0.21]. The average overall healthcare and societal cost was 34% lower in DC (US$ 188 ± 11.7) than in hospital (US$ 285 ± 13.6) (P < 0.001), and costs for households were 33% lower. CONCLUSIONS: There was a 7% greater probability of successful management of pneumonia and severe malnutrition when inpatient hospital care rather than the outpatient day clinic care was the initial method of care. However, where timely referral mechanisms were in place, 94% of children with pneumonia and severe malnutrition were successfully managed initially in a day clinic, and costs were substantially lower than with hospital admission.

OBJECTIFS: Evaluer les résultats cliniques et les coûts de la prise en charge de la pneumonie et de la malnutrition sévère dans un modèle de prise en charge en clinique de jour (CJ) (patients ambulatoires) par rapport à des soins hospitaliers (patients hospitalisés). MÉTHODES: Essai clinique randomisé où les enfants âgés de 2 mois à 5 ans avec une pneumonie et une malnutrition sévère ont été répartis de façon aléatoire en CJ ou à des soins hospitaliers. Nous avons utilisé la randomisation par blocs de longueur variable de 8 à 20 et avons généré des nombres aléatoires par ordinateur qui ont été attribués à l'une des deux interventions. Une prise en charge réussie a été définie comme la résolution des signes cliniques de pneumonie et la sortie du modèle de soins (CJ ou hospitalisation) sans nécessiter un transfert à un hôpital (CJ), ni à un autre hôpital. Tous les enfants du bras CJ et du bras soins hospitaliers ont reçu de la ceftriaxone par voie intramusculaire, un soutien nutritionnel quotidien et des micronutriments. RÉSULTATS: 470 enfants ont été assignés aléatoirement soit à des soins en CJ ou hospitaliers. Une prise en charge réussie a été obtenue pour 184 patients sur 235 (78,3%) en CJ seule contre 201 sur 235 (85,5%) en soins hospitaliers [RR (IC95%) = 0,79 (0,65 - 0,97), p = 0,02]. Au cours des six mois de suivi, 30/235 (12,8%) du groupe CJ et 36/235 (15,3%) du groupe soins hospitaliers ont nécessité une réadmission à l'hôpital [RR (IC95%) = 0,89 (0,67 - 1,18), p = 0,21]. Le coût moyen global des soins de santé et pour la société était de 34% plus faible dans le groupe CJ (188 ± 11,7 USD) que dans le groupe soins hospitaliers (285 ± 13,6 USD) (p < 0,001) et les coûts pour les ménages étaient de 33% inférieurs. CONCLUSIONS: La probabilité d'une prise en charge réussie de la pneumonie et de la malnutrition sévère était 7% plus élevée lorsque les soins hospitaliers plutôt que les soins en CJ étaient les moyens initiaux. Cependant, là où des mécanismes de référence rapides étaient en place, 94% des enfants atteints de pneumonie et de malnutrition sévère ont été pris en charge avec succès dans une clinique de jour et les coûts étaient nettement inférieurs à ceux de soins hospitaliers.

Principles and Practice of Oral Rehydration.

PURPOSE OF REVIEW: An understanding of fluid and electrolyte losses from diarrhea and mechanisms of solute cotransport led to development of oral rehydration solution (ORS), representing a watershed in efforts to reduce diarrheal disease morbidity and mortality. This report reviews the scientific rationale and modifications of ORS and barriers to universal application. RECENT FINDINGS: Solutions with osmolality and electrolyte composition different from original ORS for routine and unique pathophysiology such as in malnutrition have met with varying success. Following the conceptual rationale of sodium-glucose cotransportation to facilitate water absorption, other cotransporters and formulations have been explored with the aim to improve ORS efficacy and acceptance. ORS remains the anchor of acute watery diarrhea and dehydration management worldwide. Despite development of different formulations, the current standard solution is the mainstay of treatment for nearly all situations. Efforts to improve oral hydration solution and to increase acceptance and usage are ongoing.

Addendum guidelines for the prevention of peanut allergy in the United States: Report of the National Institute of Allergy and Infectious Diseases-sponsored expert panel.

BACKGROUND: Food allergy is an important public health problem because it affects children and adults, can be severe and even life-threatening, and may be increasing in prevalence. Beginning in 2008, the National Institute of Allergy and Infectious Diseases, working with other organizations and advocacy groups, led the development of the first clinical guidelines for the diagnosis and management of food allergy. A recent landmark clinical trial and other emerging data suggest that peanut allergy can be prevented through introduction of peanut-containing foods beginning in infancy. OBJECTIVES: Prompted by these findings, along with 25 professional organizations, federal agencies, and patient advocacy groups, the National Institute of Allergy and Infectious Diseases facilitated development of addendum guidelines to specifically address the prevention of peanut allergy. RESULTS: The addendum provides 3 separate guidelines for infants at various risk levels for the development of peanut allergy and is intended for use by a wide variety of health care providers. Topics addressed include the definition of risk categories, appropriate use of testing (specific IgE measurement, skin prick tests, and oral food challenges), and the timing and approaches for introduction of peanut-containing foods in the health care provider's office or at home. The addendum guidelines provide the background, rationale, and strength of evidence for each recommendation. CONCLUSIONS: Guidelines have been developed for early introduction of peanut-containing foods into the diets of infants at various risk levels for peanut allergy.

Addendum guidelines for the prevention of peanut allergy in the United States: Report of the National Institute of Allergy and Infectious Diseases-sponsored expert panel.

BACKGROUND: Food allergy is an important public health problem because it affects children and adults, can be severe and even life-threatening, and may be increasing in prevalence. Beginning in 2008, the National Institute of Allergy and Infectious Diseases, working with other organizations and advocacy groups, led the development of the first clinical guidelines for the diagnosis and management of food allergy. A recent landmark clinical trial and other emerging data suggest that peanut allergy can be prevented through introduction of peanut-containing foods beginning in infancy. OBJECTIVES: Prompted by these findings, along with 25 professional organizations, federal agencies, and patient advocacy groups, the National Institute of Allergy and Infectious Diseases facilitated development of addendum guidelines to specifically address the prevention of peanut allergy. RESULTS: The addendum provides 3 separate guidelines for infants at various risk levels for the development of peanut allergy and is intended for use by a wide variety of health care providers. Topics addressed include the definition of risk categories, appropriate use of testing (specific IgE measurement, skin prick tests, and oral food challenges), and the timing and approaches for introduction of peanut-containing foods in the health care provider's office or at home. The addendum guidelines provide the background, rationale, and strength of evidence for each recommendation. CONCLUSIONS: Guidelines have been developed for early introduction of peanut-containing foods into the diets of infants at various risk levels for peanut allergy.

Addendum Guidelines for the Prevention of Peanut Allergy in the United States: Report of the National Institute of Allergy and Infectious Diseases-Sponsored Expert Panel.

BACKGROUND: Food allergy is an important public health problem because it affects children and adults, can be severe and even life-threatening, and may be increasing in prevalence. Beginning in 2008, the National Institute of Allergy and Infectious Diseases, working with other organizations and advocacy groups, led the development of the first clinical guidelines for the diagnosis and management of food allergy. A recent landmark clinical trial and other emerging data suggest that peanut allergy can be prevented through introduction of peanut-containing foods beginning in infancy. OBJECTIVES: Prompted by these findings, along with 25 professional organizations, federal agencies, and patient advocacy groups, the National Institute of Allergy and Infectious Diseases facilitated development of addendum guidelines to specifically address the prevention of peanut allergy. RESULTS: The addendum provides three separate guidelines for infants at various risk levels for the development of peanut allergy and is intended for use by a wide variety of health care providers. Topics addressed include the definition of risk categories, appropriate use of testing (specific IgE measurement, skin prick tests, and oral food challenges), and the timing and approaches for introduction of peanut-containing foods in the health care provider's office or at home. The addendum guidelines provide the background, rationale, and strength of evidence for each recommendation. CONCLUSIONS: Guidelines have been developed for early introduction of peanut-containing foods into the diets of infants at various risk levels for peanut allergy.

Addendum Guidelines for the Prevention of Peanut Allergy in the United States: Report of the National Institute of Allergy and Infectious Diseases-Sponsored Expert Panel.

BACKGROUND: Food allergy is an important public health problem because it affects children and adults, can be severe and even life-threatening, and may be increasing in prevalence. Beginning in 2008, the National Institute of Allergy and Infectious Diseases, working with other organizations and advocacy groups, led the development of the first clinical guidelines for the diagnosis and management of food allergy. A recent landmark clinical trial and other emerging data suggest that peanut allergy can be prevented through introduction of peanut-containing foods beginning in infancy. OBJECTIVES: Prompted by these findings, along with 25 professional organizations, federal agencies, and patient advocacy groups, the National Institute of Allergy and Infectious Diseases facilitated development of addendum guidelines to specifically address the prevention of peanut allergy. RESULTS: The addendum provides 3 separate guidelines for infants at various risk levels for the development of peanut allergy and is intended for use by a wide variety of health care providers. Topics addressed include the definition of risk categories, appropriate use of testing (specific IgE measurement, skin prick tests, and oral food challenges), and the timing and approaches for introduction of peanut-containing foods in the health care provider's office or at home. The addendum guidelines provide the background, rationale, and strength of evidence for each recommendation. CONCLUSIONS: Guidelines have been developed for early introduction of peanut-containing foods into the diets of infants at various risk levels for peanut allergy.

Composition of Follow-Up Formula for Young Children Aged 12-36 Months: Recommendations of an International Expert Group Coordinated by the Nutrition Association of Thailand and the Early Nutrition Academy.

BACKGROUND: There are no internationally agreed recommendations on compositional requirements of follow-up formula for young children (FUF-YC) aged 1-3 years. AIM: The aim of the study is to propose international compositional recommendations for FUF-YC. METHODS: Compositional recommendations for FUF-YC were devised by expert consensus based on a detailed literature review of nutrient intakes and unmet needs in children aged 12-36 months. RESULTS AND CONCLUSIONS: Problematic nutrients with often inadequate intakes are the vitamins A, D, B12, C and folate, calcium, iron, iodine and zinc. If used, FUF-YC should be fed along with an age-appropriate mixed diet, usually contributing 1-2 cups (200-400 ml) of FUF-YC daily (approximately 15% of total energy intake). Protein from cow's milk-based formula should provide 1.6-2.7 g/100 kcal. Fat content should be 4.4-6.0 g/100 kcal. Carbohydrate should contribute 9-14 g/100 kcal with >50% from lactose. If other sugars are added, they should not exceed 10% of total carbohydrates. Calcium should provide 200 mg/100 kcal. Other micronutrient contents/100 kcal should reach 15% of the World Health Organization/Food and Agriculture Organization recommended nutrient intake values. A guidance upper level that was 3-5 times of the minimum level was established. Countries may adapt compositional requirements, considering recommended nutrient intakes, habitual diets, nutritional status and existence of micronutrient programs to ensure adequacy while preventing excessive intakes.

Cost of childhood severe pneumonia management in selected public inpatient care facilities in Bangladesh: a provider perspective.

OBJECTIVE: To estimate inpatient care costs of childhood severe pneumonia and its urban-rural cost variation, and to predict cost drivers. DESIGN: The study was nested within a cluster randomised trial of childhood severe pneumonia management. Cost per episode of severe pneumonia was estimated from a healthcare provider perspective for children who received care from public inpatient facilities. A bottom-up micro-costing approach was applied and data collected using structured questionnaire and review of the patient record. Multivariate regression analysis determined cost predictors and sensitivity analysis explored robustness of cost parameters. SETTING: Eight public inpatient care facilities from two districts of Bangladesh covering urban and rural areas. PATIENTS: Children aged 2-59 months with WHO-classified severe pneumonia. RESULTS: Data on 1252 enrolled children were analysed; 795 (64%) were male, 787 (63%) were infants and 59% from urban areas. Average length of stay (LoS) was 4.8 days (SD ±2.5) and mean cost per patient was US$48 (95% CI: US$46, US$49). Mean cost per patient was significantly greater for urban tertiary-level facilities compared with rural primary-secondary facilities (mean difference US$43; 95% CI: US$40, US$45). No cost variation was found relative to age, sex, malnutrition or hypoxaemia. Type of facility was the most important cost predictor. LoS and personnel costs were the most sensitive cost parameters. CONCLUSION: Healthcare provider cost of childhood severe pneumonia was substantial for urban located public health facilities that provided tertiary-level care. Thus, treatment availability at a lower-level facility at a rural location may help to reduce overall treatment costs.

Compositional requirements of follow-up formula for use in infancy: recommendations of an international expert group coordinated by the Early Nutrition Academy.

The follow-up formula (FUF) standard of Codex Alimentarius adopted in 1987 does not correspond to the recently updated Codex infant formula (IF) standard and current scientific knowledge. New Zealand proposed a revision of the FUF Codex standard and asked the non-profit Early Nutrition Academy, in collaboration with the Federation of International Societies for Paediatric Gastroenterology, Hepatology, and Nutrition (FISPGHAN), for a consultation with paediatric nutrition experts to provide scientific guidance. This global expert group strongly supports breastfeeding. FUF are considered dispensable because IF can substitute for breastfeeding throughout infancy, but FUF are widely used and thus the outdated current FUF standard should be revised. Like IF, FUF serve as breast milk substitutes; hence their marketing should respect appropriate standards. The compositional requirements for FUF for infants from 6 months onwards presented here were unanimously agreed upon. For some nutrients, the compositional requirements for FUF differ from those of IF due to differing needs with infant maturation as well as a rising contribution of an increasingly diversified diet with advancing age. FUF should be fed with adequate complementary feeding that is also appropriate for partially breastfed infants. FUF could be fed also after the age of 1 year without safety concerns, but different compositional requirements should be applied for optimal, age-adapted milk-based formulations for young children used only after the age of 1 year. This has not been considered as part of this review and should be the subject of further consideration.

Reslizumab in children and adolescents with eosinophilic esophagitis: results of a double-blind, randomized, placebo-controlled trial.

BACKGROUND: Eosinophilic esophagitis is a chronic allergic disease with insufficient treatment options. Results from animal studies suggest that IL-5 induces eosinophil trafficking in the esophagus. OBJECTIVE: We sought to evaluate the effect of reslizumab, a neutralizing antibody against IL-5, in children and adolescents with eosinophilic esophagitis. METHODS: Patients with symptom severity scores of moderate or worse and an esophageal biopsy specimen with 24 or more intraepithelial eosinophils per high-power field were randomly assigned to receive infusions of 1, 2, or 3 mg/kg reslizumab or placebo at weeks 0, 4, 8, and 12. The coprimary efficacy measures were changes in peak esophageal eosinophil count and the physician's global assessment score at week 15 (end of therapy). RESULTS: Two-hundred twenty-six patients received study medication. Median reductions from baseline to the end of therapy in peak esophageal eosinophil counts were 59%, 67%, 64%, and 24% in the 1, 2, and 3 mg/kg reslizumab (all P < .001) and placebo groups, respectively. All treatment groups, including the placebo group, showed improvements in physician's global assessment scores; the differences between the reslizumab and placebo groups were not statistically significant. The most common adverse events in the reslizumab groups were headache, cough, nasal congestion, and upper respiratory tract infection. One patient in each reslizumab group and 2 in the placebo group had serious adverse events; none were considered related to the study medication. CONCLUSION: Reslizumab significantly reduced intraepithelial esophageal eosinophil counts in children and adolescents with eosinophilic esophagitis. However, improvements in symptoms were observed in all treatment groups and were not associated with changes in esophageal eosinophil counts.

Older Infant-Young Child "Formulas".

The category of "formulas" directed at older infants and toddlers 6 to 36 months of age has increased in prominence over the last years but is characterized by lack of standardization in nomenclature and composition as well as questionable marketing practices. There has been uncertainty and misperception regarding some of the roles of these beverages in ensuring adequate childhood nutrition. The aim of this clinical report is to review the context, evidence, and rationale for older infant-young child formulas, followed by recommendations.

Cardiometabolic risk factors in South American children: A systematic review and meta-analysis.

BACKGROUND: Cardiometabolic risk factors (impaired fasting glucose, abdominal obesity, high blood pressure, dyslipidemia) cluster in children, may predict adult disease burden, and are inadequately characterized in South American children. OBJECTIVES: To quantify the burden of cardiometabolic risk factors in South American children (0-21 years) and identify knowledge gaps. METHODS: We systematically searched PubMed, Google Scholar, and the Latin American and Caribbean Health Sciences Literature via Virtual Health Library from 2000-2021 in any language. Two independent reviewers screened and extracted all data. RESULTS: 179 studies of 2,181 screened were included representing 10 countries (n = 2,975,261). 12.2% of South American children experienced obesity, 21.9% elevated waist circumference, 3.0% elevated fasting glucose, 18.1% high triglycerides, 29.6% low HDL cholesterol, and 8.6% high blood pressure. Cardiometabolic risk factor definitions varied widely. Chile exhibited the highest prevalence of obesity/overweight, low HDL, and impaired fasting glucose. Ecuador exhibited the highest prevalence of elevated blood pressure. Rural setting (vs. urban or mixed) and indigenous origin protected against most cardiometabolic risk factors. CONCLUSIONS: South American children experience high rates of obesity, overweight, and dyslipidemia. International consensus on cardiometabolic risk factor definitions for children will lead to improved diagnosis of cardiometabolic risk factors in this population, and future research should ensure inclusion of unreported countries and increased representation of indigenous populations.

Effectiveness, safety and economic viability of daycare versus usual hospital care management of severe pneumonia with or without malnutrition in children using the existing health system of Bangladesh: a cluster randomised controlled trial.

Background: We aimed to define clinical and cost-effectiveness of a Day Care Approach (DCA) alternative to Usual Care (UC, comparison group) within the Bangladesh health system to manage severe childhood pneumonia. Methods: This was a cluster randomised controlled trial in urban Dhaka and rural Bangladesh between November 1, 2015 and March 23, 2019. Children aged 2-59 months with severe pneumonia with or without malnutrition received DCA or UC. The DCA treatment settings comprised of urban primary health care clinics run by NGO under Dhaka South City Corporation and in rural Union health and family welfare centres under the Ministry of Health and Family welfare Services. The UC treatment settings were hospitals in these respective areas. Primary outcome was treatment failure (persistence of pneumonia symptoms, referral or death). We performed both intention-to-treat and per-protocol analysis for treatment failure. Registered at www.ClinicalTrials.gov, NCT02669654. Findings: In total 3211 children were enrolled, 1739 in DCA and 1472 in UC; primary outcome data were available in 1682 and 1357 in DCA and UC, respectively. Treatment failure rate was 9.6% among children in DCA (167 of 1739) and 13.5% in the UC (198 of 1472) (group difference, -3.9 percentage point; 95% confidence interval (CI), -4.8 to -1.5, p = 0.165). Treatment success within the health care systems [DCA plus referral vs. UC plus referral, 1587/1739 (91.3%) vs. 1283/1472 (87.2%), group difference 4.1 percentage point, 95% CI, 3.7 to 4.1, p = 0.160)] was better in DCA. One child each in UC of both urban and rural sites died within day 6 after admission. Average cost of treatment per child was US$94.2 (95% CI, 92.2 to 96.3) and US$184.8 (95% CI, 178.6 to 190.9) for DCA and UC, respectively. Interpretation: In our population of children with severe pneumonia with or without malnutrition, >90% were successfully treated at Day care Clinics at 50% lower cost. A modest investment to upgrade Day care facilities may provide a cost-effective, accessible alternative to hospital management. Funding: UNICEF, Botnar Foundation, UBS Optimus Foundation, and EAGLE Foundation, Switzerland.

Influence of Helicobacter pylori infection on gastric acid secretion in pre-school Bangladeshi children.

BACKGROUND: The effect of Helicobacter pylori (H. pylori) infection on gastric acid secretion (GAS) is poorly defined in children. OBJECTIVE: To determine whether H. pylori infection is associated with abnormal GAS in children. METHODS: We studied 30 H. pylori-infected children (identified by a positive urea breath test) and 30 noninfected children of both sexes, aged 2-5 years. Gastric pH and GAS were measured before and 8 weeks after the completion of a 2-week course of anti- H. pylori therapy (omeprazole, clarithromycin, and amoxicillin). Gastric acid output (GAO) was quantified during a 1-h basal period (GAO-B) (mmol/h) and a 1-hour stimulated period (GAO-S) (mmol/hour) following subcutaneous administration of pentagastrin (6 µg/kg). RESULTS: A significantly greater number of infected children had a high gastric pH (>4.0, p = 0.03) compared with the noninfected group. GAO-B and GAO-S in H. pylori-infected children were significantly lower, around 50%, compared with children without H. pylori infection. H. pylori-eradication therapy resulted in a rise of both the mean GAO-B (paired t-test before vs. after therapy; 0.28 ± 0.40 vs. 0.62 ± 1.0, p = 0.12) and GAO-S (before vs. after therapy; 2.0 ± 1.4 vs. 3.4 ± 2.5, p = 0.001), with values reaching equivalence to those in the H. pylori-negative children (0.71 ± 0.56 for BAO, 3.3 ± 2.0 for SAO, p = NS). CONCLUSION: The results suggest that the gastric barrier is compromised in children with H. pylori infection in Bangladesh. Improvement of GAO following anti- H. pylori therapy suggests a causal link between H. pylori infection and depressed GAO in this population.