A randomized trial of the acceptability of a daily multi-allergen food supplement for infants.
Ontology highlight
ABSTRACT:
SUBMITTER: Holl JL
PROVIDER: S-EPMC7318591 | biostudies-literature | 2020 May
REPOSITORIES: biostudies-literature
Publications
A randomized trial of the acceptability of a daily multi-allergen food supplement for infants.
Holl Jane L JL Bilaver Lucy A LA Finn Daniel J DJ Savio Kay K
Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology 20200220 4
Similar Datasets
Project description:OBJECTIVES:To estimate the proportion of infants introduced to peanut and other common food allergens by 12 months of age; to collect information about parent-reported reactions to food. DESIGN, SETTING:Observational cohort study, applying the SmartStartAllergy SMS protocol and online questionnaire to parents of 12-month-old infants attending 69 Australian general practices between 21 September 2018 and 3 May 2019. PARTICIPANTS:3374 parents recruited via the 69 participating general practices. MAIN OUTCOME MEASURES:Proportions of infants who had eaten peanut and other common food allergens; proportions with parent-reported reactions to food. RESULTS:1940 of 3374 invited parents participated in the study (response rate, 57%), of whom 836 (46%) completed the online questionnaire. At 12 months of age, 1673 of 1940 infants had eaten peanut-including foods (86.2%; 95% confidence interval [CI], 84.6-87.7%); 235 of 1831 parents (12.8%; 95% CI, 11.3-14.5%) reported food-related reactions. Questionnaire responses indicated that dairy was the food type most frequently reported to cause a food-related reaction (72 of 835 exposed infants, 8.6%; 95% CI, 6.8-11%); peanut-related reactions were reported for 20 of 764 exposed children (2.6%; 95% CI, 1.6-4.0%). 97 of 250 parent-reported reactions to food (39%) did not include symptoms that suggested an IgE-mediated allergic reaction. CONCLUSION:Infant feeding practices in Australia have changed over the past decade; a large majority of infants are now fed peanut before 12 months of age. The SmartStartAllergy program allows monitoring of infant feeding practices in primary care, as well as of parent-reported reactions to food in infants.
| S-EPMC7187408 | biostudies-literature
Project description:Stunting is reportedly associated with low circulating levels of essential amino acids (EAAs). This study examined the effect of a macronutrient- and micronutrient-fortified complementary food supplement (KOKO Plus) on specific plasma EAA levels and stunting in infants aged 6-18 months. In a single-blind cluster-randomized controlled trial conducted in Ghana, infants were enrolled at 6 months and followed until 18 months. Thirty-eight communities were randomly assigned to receive KOKO Plus (KP, fourteen communities, n = 321), multiple-micronutrient powder (MN, thirteen communities, n = 327), or only nutritional education as control group (NE, eleven communities, n = 318), and all groups received nutrition education. Plasma amino acids (AAs) were measured at 6, 12, and 18 months (end point). Mixed-effects models were used to assess the effect of the intervention on plasma AAs, and the relationship between plasma branched-chain AAs (BCAAs) and the risk of stunting was assessed. At the end point, total BCAA concentrations (±standard error) significantly exceeded baseline in the KP (284.2 ± 4.3 μM) and NE (289.1 ± 4.4 μM) groups but not the MN group (264.4 ± 4.1 μM). After adjustment for compliance at 200 sachets, plasma BCAAs exceeded in the KP group (284.5 ± 4.2 μM) compared to the MN group (264.6 ± 4 μM). Plasma BCAAs were positively correlated with changes in length-for-age Z-score from baseline (R = 0.327, p = 0.048). In conclusion, the plasma BCAA concentrations of infants that received KP and the NE group was significantly higher compared to the MN group but there were no differences between the KP and NE group at end point. Improved plasma BCAAs may be due to improved nutrient intake by infants exposed to KP or NE. Low BCAAs were associated with stunting, replicating the previous finding. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT03181178?term=NCT03181178&draw=2&rank=1, identifier: NCT03181178.
| S-EPMC8514778 | biostudies-literature
Project description:BackgroundAfter the first six months of exclusive breastfeeding, children are introduced to liquids and semi-solid food, known as the complementary feeding phase. This phase is critical because it is often accompanied by improper feeding in children, which may lead to wasting and other nutrition problems. Fortified biscuits have been provided for wasting children as a nationwide programme. However, the ability of children to accept food supplementation remains questionable. This paper describes the protocol of a study investigating the efficacy of food supplementation (PMT biscuit) and nutrition education to improve the nutritional status of wasting children in Indonesia.MethodThe efficacy of a government food supplementation programme will be examined using a randomized control trial design. Parents with wasting children aged 6-17 months will be recruited to participate in the study. After obtaining informed consent and pre-intervention measures, participants will be assigned into three arms of intervention with PMT biscuits and/or nutrition education only. The two primary outcomes for this study are the nutritional status of wasting children and PMT biscuit compliance. Characteristics of all subjects in each arm will be analysed and compared with each other to assess their comparability at the beginning. The data will be collected at pre-intervention, at 3 months of intervention, post-intervention, and at the 6- to 9-month follow up.DiscussionThis paper aims to describe the study protocol of a randomized controlled trial investigating the effects of different PMT biscuit portion and nutrition education in two arms and nutrition education only in another arm. This study is important because it will provide evidence for the Indonesian government regarding the efficacy of food supplementation and/or food-based recommendations to improve the nutritional status of wasting children aged 6-23 months in Indonesia.Trial registrationThe study has been registered at clinicaltrials.gov, maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH), on April 26, 2018, and was last updated on April 30, 2018 (registration number: NCT03509155 ).
| S-EPMC6417132 | biostudies-literature
Project description:The lymphocyte stimulation test (LST) helps with the diagnosis of non-IgE-mediated gastrointestinal food allergies. However, The LST requires large volumes of fresh peripheral blood and long culture times.The purpose of this study was to develop a novel LST. we obtained whole blood from patients with non-IgE-GI-FAs to cow’s milk and disease control children. And, we stimulated it with α-casein and Pmix, which is a mixture of four milk protein components (α-casein, κ-casein, α-lactalbumin, or β-lactoglobulin for 24 hours. Then we analyzed genome-wide gene expression using microarray and selected up- or down-regulated genes Nine putative marker genes, including those known to be involved in allergic inflammation, such as IL2RA, CCL17 and CISH were specific to patient group after stimulation with α-casein. On the other hand, 232 marker genes were specific to patient group after stimulation with Pmix.
2022-02-01 | GSE171660 | GEO
Project description:We conducted a pilot diagnostic randomized clinical trial (RCT) to examine the feasibility, acceptability, and preliminary outcomes of adding bowel ultrasound (BUS) to the diagnostic evaluation for necrotizing enterocolitis (NEC). Infants ≤ 32 weeks' gestational age with NEC concern were randomized to undergo abdominal X-ray (AXR) or AXR + BUS. The primary outcome was study feasibility. Secondary outcomes included rates of NEC diagnosis and duration of treatment with bowel rest and antibiotics. A total of 56 infants were enrolled; 16 developed NEC concern and were randomized. Rates of recruitment (56/82 = 68%), retention (16/16 = 100%), and protocol compliance (126/127 = 99%) met pre-specified thresholds for feasibility. No significant differences in rates of NEC diagnosis were found between the two groups. Durations of bowel rest and antibiotic treatment were also similar. Conclusion: Our study supports the feasibility of conducting a definitive diagnostic RCT to establish safety and efficacy of BUS for NEC. Clinical trial registration: The study was registered at https://clinicaltrials.gov (NCT03963011). What is Known: • Bowel ultrasound (BUS) is increasingly being utilized as an adjunct to abdominal radiographs in evaluating for necrotizing enterocolitis (NEC). • The impact of BUS on patient outcomes is unknown. What is New: • A diagnostic randomized controlled trial study design to determine safety and effectiveness of adding BUS to NEC evaluation is feasible and acceptable.
| S-EPMC9203774 | biostudies-literature
Project description:In term infants it is recommended to introduce solids between the 17th and 26th week of life, whereas data for preterm infants are missing. In a prospective, two-arm interventional study we investigated longitudinal growth of VLBW infants after early (10-12th) or late (16-18th) week of life, corrected for term, introduction of standardized complementary food. Primary endpoint was height at one year of age, corrected for term, and secondary endpoints were other anthropometric parameters such as weight, head circumference, BMI, and z-scores. Among 177 infants who underwent randomization, the primary outcome could be assessed in 83 (93%) assigned to the early and 83 (94%) to the late group. Mean birthweight was 941 (SD ± 253) g in the early and 932 (SD ± 256) g in the late group, mean gestational age at birth was 27 + 1/7 weeks in both groups. Height was 74.7 (mean; SD ± 2.7) cm in the early and 74.4 cm (mean; SD ± 2.8; n.s.) cm in the late group at one year of age, corrected for term. There were no differences in anthropometric parameters between the study groups except for a transient effect on weight z-score at 6 months. In preterm infants, starting solids should rather be related to neurological ability than to considerations of nutritional intake and growth.
| S-EPMC8839701 | biostudies-literature
Project description:BackgroundFood reinforcement or one's motivation to eat may be established early in life; it might not be the food reinforcement per se that drives weight gain, but rather the imbalance between food and nonfood reinforcement.ObjectivesWe implemented a 2-y randomized, controlled trial to assess the effects of a music enrichment program (music, n = 45) compared with an active play date control (control, n = 45) in 9- to 15-mo-old healthy infants who were strongly motivated to eat.MethodsThe 12-mo intensive intervention phase included 4 semesters of Music Together® or a play date program (Winter, Spring, Summer, and Fall), comprised of once per week group meetings, followed by a 12-mo maintenance phase with monthly meetings. Parents were encouraged to listen to the Music Together® program CD or play with the play date group's toy with their infants at home, respectively. We performed a modified intention-to-treat analysis using all randomly assigned, non-excluded subjects for the outcome measures [relative reinforcing value of food (RRVfood), food reinforcement, music reinforcement, and weight-for-length z-score (WLZ)].ResultsThere were significant differential group changes across time for RRVfood (group × month; P = 0.016; Cohen's f2 = 0.034). The music group had significantly greater RRVfood decreases than the control group from baseline to the end of the intensive intervention phase (music change = -0.211; control change = -0.015; P = 0.002; Cohen's D = 0.379). However, these differences were not maintained during months 12-24 (music change = -0.187; control change = -0.143; P = 0.448; D = 0.087). We observed an overall moderation effect by sex for food reinforcement and WLZ. Boys in the music group had a significant attenuation in food reinforcement and WLZ compared with boys in the control group.ConclusionsThis study extends our knowledge in infant eating behavior by providing insight into the role of nonfood alternatives in altering one's motivation to eat. There may be sex differences in altering one's motivation to eat.This trial was registered at clinicaltrials.gov as NCT02936284.
| S-EPMC9761746 | biostudies-literature
Project description:There is growing evidence supporting the benefit of human milk oligosaccharides (HMOs) on reducing risk of illnesses and improving immune function in newborn infants, but evidence in pre-term infants is lacking. This randomized, double-blind, placebo-controlled trial (NCT03607942) of pre-term infants evaluated the effects of HMO supplementation on feeding tolerance, growth, and safety in 7 neonatal units in France. Pre-term infants (27-33 weeks' gestation, birth weight <1,700 g) were randomized early after birth to receive HMO supplement (n = 43) [2'-fucosyllactose (2'FL) and lacto-N-neotetraose (LNnT) in a 10:1 ratio (0.374 g/kg body weight/day)] or an isocaloric placebo (n = 43) consisting of only glucose (0.140 g/kg/day) until discharge from the neonatal unit. Anthropometric z-scores were calculated using Fenton growth standards. Primary outcome was feeding tolerance, measured by non-inferiority (NI) in days to reach full enteral feeding (FEF) from birth in HMO vs. placebo group (NI margin = 4+ days). Mean number of days on intervention prior to FEF was 8.9 and 10.3 days in HMO and placebo, respectively. Non-inferiority in time to reach FEF in HMO (vs. placebo) was achieved [LS mean difference (95% CI) = -2.16 (-5.33, 1.00); upper bound of 95% CI < NI margin] in full analysis set and similar for per protocol. Adjusted mean time to reach FEF from birth was 2 days shorter in HMO (12.2) vs. placebo (14.3), although not statistically significant (p = 0.177). There was no difference in weight-for-age z-scores between groups throughout the FEF period until discharge. Length-for-age z-scores were higher in HMO at FEF day 14 [0.29 (0.02, 0.56), p = 0.037] and 21 [0.31 (0.02, 0.61), p = 0.037]. Head circumference-for-age z-score was higher in HMO vs. placebo at discharge [0.42 (0.12, 0.71), p = 0.007]. Occurrence of adverse events (AEs) was similar in both groups and relatively common in this population, whereas 2.3 and 14.3%, respectively, experienced investigator-confirmed, related AEs. HMO supplementation is safe and well-tolerated in pre-term infants. After 9 days of supplementation, the HMO group reached FEF 2 days earlier vs. placebo, although the difference was not statistically significant. In addition, HMO supplementation supports early postnatal growth, which may have a positive impact on long-term growth and developmental outcomes.
| S-EPMC9119431 | biostudies-literature
Project description:This randomized controlled trial evaluated the effect of a 5-week daily skin-to-skin contact (SSC) intervention between mothers and their full-term infants, compared with care-as-usual, on exclusive and continued breastfeeding duration during the first post-natal year. Healthy pregnant women (n = 116) from a community sample were enrolled and randomly allocated to the SSC or care-as-usual condition. SSC mothers were requested to provide one daily hour of SSC for the first five post-natal weeks. Twelve months post-partum, mothers indicated the number of exclusive and continued breastfeeding months. Multiple regression analyses were conducted using intention-to-treat, per-protocol and exploratory dose-response frameworks. In intention-to-treat analyses, exclusive and continued breastfeeding duration was not different between groups (exclusive: 3.61 ± 1.99 vs. 3.16 ± 1.77 months; adjusted mean difference 0.28, 95% confidence interval [CI] -0.33 to 0.89; p = 0.36; continued: 7.98 ± 4.20 vs. 6.75 ± 4.06 months; adjusted mean difference 0.81, 95% CI -0.46 to 2.08; p = 0.21). In per-protocol analyses, exclusive and continued breastfeeding duration was longer for SSC than care-as-usual dyads (exclusive: 4.89 ± 1.26 vs. 3.25 ± 1.80 months; adjusted mean difference 1.28, 95% CI 0.31-2.24; p = 0.01; continued: 10.81 ± 1.97 vs. 6.98 ± 4.08 months; adjusted mean difference 2.33, 95% CI 0.13-4.54; p = 0.04). Exploratory dose-response effects indicated that more SSC hours predicted longer exclusive and continued breastfeeding duration. This study demonstrates that for the total group, the 5-week daily SSC intervention did not extend exclusive and continued breastfeeding duration. However, for mothers performing a regular daily hour of SSC, this simple and accessible intervention may extend exclusive and continued breastfeeding duration by months. Future studies are required to confirm these promising findings. Trial registration: Netherlands Trial Register (NTR5697).
| S-EPMC8710110 | biostudies-literature
Project description:Food reactions (FR) are multifactorial and impacted by medical, demographic, environmental, and immunologic factors. We hypothesized that multi-omic analyses of host-microbial factors in saliva would enhance our understanding of FR development. This longitudinal cohort study included 164 infants followed from birth through two years. The infants were identified as FR (n = 34) or non-FR (n = 130) using the Infant Feeding Practice II survey and medical record confirmation. Saliva was collected at six months for the multi-omic assessment of cytokines, mRNAs, microRNAs, and the microbiome/virome. The levels of one miRNA (miR-203b-3p, adj. p = 0.043, V = 2913) and one viral phage (Proteus virus PM135, adj. p = 0.027, V = 2955) were lower among infants that developed FRs. The levels of one bacterial phylum (Cyanobacteria, adj. p = 0.048, V = 1515) were higher among infants that developed FR. Logistical regression models revealed that the addition of multi-omic features (miR-203b-3p, Cyanobacteria, and Proteus virus PM135) improved predictiveness for future FRs in infants (p = 0.005, X2 = 12.9), predicting FRs with 72% accuracy (AUC = 0.81, sensitivity = 72%, specificity = 72%). The multi-omic analysis of saliva may enhance the accurate identification of infants at risk of FRs and provide insights into the host/microbiome interactions that predispose certain infants to FRs.
| S-EPMC9690066 | biostudies-literature