Growth Patterns of 11-29-Month-Old Children Consuming Young Child Formula: Secondary Analysis of a Randomized, Controlled Study.

INTRODUCTION: The impact of young child formula (YCF) consumption on children's growth, particularly under suboptimal conditions, has scarcely been studied. In the current study, weight-for-age (WAZ), length-for-age (LAZ), and BMI-for-age (BAZ) z-score development was evaluated in children from five different countries (n = 668) who participated in a double-blind, randomized, controlled trial. METHODS: The children (1-3 years old) were randomized to one of two intervention YCFs (with presence or absence of prebiotics and n-3 LCPUFAs) during 52 weeks of intervention. Additional stratified analyses evaluated the growth patterns of underweight, overweight, or stunted children. RESULTS: No apparent differences in anthropometric measurements were observed between the intervention groups. In both YCF intervention groups, mean WAZ, LAZ and BAZ development was indicative of adequate growth during the intervention period. Stratified analyses showed stable WAZ and BAZ development among children with a healthy weight or overweight at baseline. Among underweight and stunted children, normalization in mean weight (∼1 SD) and length (∼0.8 SD) gain, respectively, was observed. CONCLUSION: The current study suggests that consumption of YCF, either or not containing prebiotics and n-3 LCPUFAs, is associated with adequate growth among young children. This association may depend on the child's baseline nutritional status. Future studies to assess the potential role of YCF in supporting adequate weight/length gain among children at risk for undernutrition are warranted.

Effects of growing-up milk supplemented with prebiotics and LCPUFAs on infections in young children.

OBJECTIVE: The aim of this study was to investigate the effect of growing-up milk (GUM) with added short-chain galacto-oligosaccharides (scGOS)/long-chain fructo-oligosaccharides (lcFOS) (9:1) (Immunofortis) and n-3 long-chain polyunsaturated fatty acids (LCPUFAs) on the occurrence of infections in healthy children attending day care centres. METHODS: In a randomised double-blind controlled, parallel, multicountry intervention study, 767 healthy children, ages 11 to 29 months, received GUM with scGOS/lcFOS/LCPUFAs (the active group, n = 388), GUM without scGOS/lcFOS/LCPUFAs (the control group, n = 379), or cow's milk (n = 37) for 52 weeks. The primary outcome measure was the number of episodes of upper respiratory tract infections or gastrointestinal infections based on a combination of subject's illness symptoms reported by the parents during the intervention period. RESULTS: Children in the active group compared with the control group had a decreased risk of developing at least 1 infection (299/388 [77%] vs 313/379 [83%], respectively, relative risk 0.93, 95% confidence interval [CI] 0.87-1.00; logistic regression P = 0.03). There was a trend toward a reduction (P = 0.07) in the total number of infections in the active group, which was significant when confirmed by one of the investigators (268/388 [69%] vs 293/379 [77%], respectively, relative risk 0.89, 95% CI 0.82-0.97; P = 0.004, post hoc). More infectious episodes were observed in the cow's milk group, when compared with both GUM groups (34/37 [92%] vs 612/767 [80%], respectively, relative risk 1.15, 95% CI 1.04-1.28). CONCLUSIONS: This is the first study in children to show a reduced risk of infection following consumption of GUM supplemented with scGOS/lcFOS/n-3 LCPUFAs. The borderline statistical significance justifies a new study to confirm this finding.

A randomised, double-blind study of polyethylene glycol 4000 and lactulose in the treatment of constipation in children.

BACKGROUND: Chronic constipation is frequent in children. The objective of this study is to compare the efficacy and safety of PEG 4000 and lactulose for the treatment of chronic constipation in young children. METHODS: This randomised, double-blind study enrolled 88 young children aged 12 to 36 months, who were randomly assigned to receive lactulose (3.3 g per day) or PEG 4000 (8 g per day) for four weeks. The primary efficacy variable was stool frequency during the fourth week of treatment. Secondary outcomes were the number and frequency of subjective symptoms associated with defecation at each visit. RESULTS: Stool frequency was comparable in the two groups at baseline (lactulose: 0.7 ± 0.5; PEG 4000: 0.5 ± 0.55). Mean stool frequency increased from 0.70 ± 0.50 stools/day at baseline to 0.80 ± 0.41 at Week 4 in the lactulose group and from 0.50 ± 0.55 to 1.10 ± 0.55 stools/day in the PEG 4000 group. A significant difference was observed in the adjusted mean change from baseline, which was 0.15 stools/day in the lactulose group and 0.51 stools/day in the PEG 4000 group, with a least-squares mean difference of 0.36 stools/day [95% CI: 0.16 to 0.56]. With respect to secondary outcome variables, stool consistency and ease of stool passage improved more in the PEG 4000 group (p = 0.001). The incidence of adverse events was similar in both groups, the majority of which were mild. CONCLUSIONS: PEG 4000 has superior efficacy to lactulose for the treatment of chronic constipation in young children and is well tolerated. TRIAL REGISTRATION: US National Institute of Health Clinical Trials database; study NCT00255372 first registered 17th November 2005.

Tolerance, safety, and effect on the faecal microbiota of an enteral formula supplemented with pre- and probiotics in critically ill children.

OBJECTIVES: The aim of this study was to demonstrate the tolerance and safety of an enteral formula containing prebiotics/probiotics, and its effect on the faecal microbiota in critically ill children. SUBJECTS AND METHODS: Ninety-four patients between 1 and 3 years old under mechanical ventilation requiring enteral feeding were randomised to receive either a test formula containing a synbiotic blend (composed of 2 probiotic strains [Lactobacillus paracasei NCC 2461 and Bifidobacterium longum NCC 3001], fructooligosaccharides [FOS], inulin, and Acacia gum), or a control formula. Patients remained in the intensive care unit for 7 days and were examined at day 14. Tolerance was assessed by overall caloric intake and time to reach caloric goal. Safety was assessed by abdominal distention, vomiting, and stool frequency. Microbiota was analysed by culture- and molecular-based methods. RESULTS: Overall caloric intake and time to reach caloric goal were similar between groups (noninferiority was shown). Abdominal distention, vomiting, and stool frequency were not affected by the supplementation with pre- and probiotics. Faecal bifidobacteria were higher in the test group at the end of the study. A similar trend was observed for total lactobacilli. L paracasei NCC 2461 and B longum NCC 3001 were detected in 80.4% and 17% of the test group patients, respectively. Enterobacteria levels remained unchanged during hospitalisation in the control group but diminished in the test group. CONCLUSIONS: The enteral formula supplemented with synbiotics was well tolerated by children in intensive care units; it was safe and produced an increase in faecal bacterial groups of previously reported beneficial effects.

Randomized, double-blind clinical trial of a lactose-free and a lactose-containing formula in dietary management of acute childhood diarrhea.

BACKGROUND: Refeeding of artificially fed infants with lactose-containing formula after oral rehydration therapy in the treatment of acute diarrhea was concluded to be indifferent to non-lactose formula by a meta-analysis. In Thai as well as Asian infants and children with low lactase level from genetically determinant and with rotavirus infection, lactose malabsorption is most likely to occur and cause delayed recovery. The aim of this study was to compare the effect of a lactose-free and a lactose-containing formula in dietary management of acute childhood diarrhea. PATIENTS AND METHOD: A randomized, double-blind clinical trial of 80 male children, formula-fed, aged 3 to 24 months, admitted with acute watery diarrhea and mild or moderate dehydration, was carried out. All children received oral rehydration therapy for the first 4 hours. After appropriate rehydration, they were fed either a lactose-free formula (Dumex Lactose-Free Formula; treatment group, n = 40) or a lactose-containing formula (Dumex Infant Formula; control group, n = 40) in adjunction with oral rehydration solution. In addition, the infants were fed rice gruel as tolerated. Comparisons of duration of diarrhea, weight gain, vomiting, biochemical changes, stool frequency and weight and unscheduled intravenous fluid were made. RESULTS: Three children (2 treatment, and 1 control) dropped out from the study. The total number of unscheduled intravenous infusions were 6 of 80 children (7.5%), including 2 (5.0%) in the treatment group and 4 (10.0%) in the control group. Three children in the control group did not resolve from diarrhea within 7 days of treatment. Rotavirus was identified in approximately 50% of the children in each group. Using survival analysis, the median duration of diarrhea was significantly shortened by 20.5 hours in the treatment group compared to the control group (77.0 hours in the treatment group vs 97.5 hours in the control group; P = 0.002). Significantly decrease in stool frequency and increase in percent weight gain were seen in the treatment group at 24 hours. Moderate acidosis cleared up to near normal at 24 hours in the treatment group but acidosis persisted in the control group. In the rotavirus diarrhea subgroup, moderate acidosis turned to be mild in treatment group, but acidosis was unchanged with increased plasma chloride level in the control at 24 hours thus suggesting that the children in the control group might have lactose malabsorption and osmotic diarrhea. Duration of rotavirus diarrhea was shortened 23.6 hours in treatment group compared to the control (P = 0.0034). CONCLUSIONS: In this study, lactose-free formula was shown to be effective in the dietary management of acute childhood diarrhea. Duration of diarrhea was shortened, weight gain was better, and stool frequency was less when compared to lactose-containing formula. Moderate acidosis cleared up spontaneously at 24 hours. Unscheduled IV could be decreased by 50%. Children receiving lactose-free formula tolerated it well. Data of subgroup analysis of rotavirus diarrhea revealed lactose-free formula scored higher than the control group for all parameters studied.

Prevalence and phylogenetic analysis of rotavirus genotypes in Thailand between 2007 and 2009.

Rotaviruses are the most common cause of severe diarrhea among infants and young children worldwide, especially in developing countries. In Thailand, rotavirus has presented a major public health problem causing severe diarrhea in infants and young children. It was responsible for about one-third of diarrheal diseases in hospitalized patients. In this study, we have analyzed the distribution and performed molecular characterization of rotaviruses circulating in infants and young children with diarrhea admitted to the city and rural hospitals in Thailand between July 2007 and May 2009. Group A human rotavirus was detected in 158 (28.4%) of 557 fecal specimens by RT-PCR. The peak incidence of infection was found in the winter months between December and March. The G1P[8] strain was identified as the most prevalent (49.4%) followed by G9P[8] (22.2%), G2P[4] (20.2%) and G3P[8] (0.6%). The uncommon strains G12P[8], G12P[6] and G3P[9] were also detected. Phylogenetic analysis of selected G and P genotypes isolated in this study was performed to compare with the reference strains from different countries. Emergence of G12 in the northern part of Thailand was observed and phylogenetic analysis demonstrated close relation between Thai isolates and strains from India. The present study reveals the recurring changing genotypes of rotavirus circulating in Thailand. The genetic association between isolates from Thailand and other countries ought to be considered with regard to local and global dissemination of rotavirus as it is crucial for prevention especially, with respect to vaccine implementation.

A rapid serologic test and immunoblotting for the detection of Helicobacter pylori infection in children.

The gold standard for the diagnosis of Helicobacter pylori infection requires an endoscopic biopsy of gastric mucosa for histological examination, urease test and culture. Noninvasive serological tests are useful as a screening test for H. pylori infection. The aim of this study was to evaluate the performance of a rapid office-based serologic test, using immunochromatography ICM, and the immunoblotting for the diagnosis of H. pylori infection in Thai children. Eighty-two symptomatic children, 30 boys and 52 girls (mean age 9.2+/-3.8 years; range, 1.2-16.0 years) who had no previous treatment for H. pylori underwent upper endoscopy. Biopsies were obtained from the gastric body and antrum for histopathology and rapid urease test. Serum samples collected from all patients were tested for H. pylori IgG antibodies using ICM (Assure H. pylori Rapid Test, Genelabs Diagnostics, Singapore). Immunoblotting (HelicoBlot 2.1, Genelabs Diagnostics, Singapore) was tested in sera of 75 patients to detect antibodies to specific antigens of H. pylori. Positive H. pylori status was defined as positive for both histology and rapid urease test. Of 82 patients, 25 (30.5%) were H. pylori positive, 56 (68.3%) were H. pylori negative and one was equivocal. ICM assay yielded a positive result in 24 of the 25 H. pylori-positive patients (96.0%) and 3 of the 56 H. pylori-negative patients (5.4%). The immunoblotting yielded a positive result in all of 22 H. pylori-positive patients (100%) and in 2 of the 52 H. pylori-negative patients (3.8%). Obtained ICM's sensitivity, specificity, positive predictive value, negative predictive value and accuracy were 96.0, 94.6, 88.9, 98.1 and 95.1%, with immunoblotting 100.0, 96.2, 91.6, 100.0, and 97.3%, respectively. The immunochromatographic and immunoblot tests are non-invasive, reliable and useful for the diagnosis of H. pylori infection in Thai children.