View clinical trials related to Infant Formula.
Filter by:The main purpose of this study is to describe the pattern of RIF consumption in real life conditions, whatever the reasons of initiation and the chosen formula. The main objective is to study the reasons for prescribing a RIF during the first year of life, as per the pediatrician. Consumption started before 6 months of age, when milk and infantile formulas predominates in the baby's feeding, is of particular interest.
Background: Human milk oligosaccharides (HMO) and microbiota are both key factors for infants to shape the gut flora and develop the immune system. Breastfed infant is beneficial to prevent the occurrence of infantile colic (IC) and atopic dermatitis (AD), which may through shaping a healthy microbiota. However, the gut microbiota biomarkers representing IC and AD have not yet been discovered. In addition, the effectiveness of supplement of HMO in infant formula reduce the incidence of IC and AD in infants is still debate.
This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.
Breastfeeding is the recommended diet for all infants during the first half of infancy and is associated with numerous health benefits. However, when breastfeeding is not possible, an infant formula is the only nutritive alternative. Formula-fed infants have a different growth pattern compared to breastfed infants. Studies have shown that the higher protein content in infant formula compared to breastmilk results in a more rapid weight gain and an increased risk of overweight and obesity in childhood. For this reason, both quantity and quality of protein in infant formulae have been optimized during the last decade, to better meet the needs of infants and to support growth close to that of breastfed infants. Protein hydrolysis, a common modification of infant formulae, has originally been developed for treatment of cow's milk protein allergy. Certain hydrolysed formulae have been suggested to prevent atopic eczema when given to infants with a family history of allergic disease but as of yet, the allergy preventive effect in infants without increased risk of allergic disease has been little studied. Partially hydrolysed infant formulae have also been suggested to reduce common functional gastrointestinal symptoms in infants. New protein hydrolysates are continually developed for use in infant formulae, with the aim of reducing allergenicity, while ensuring optimal growth and development of infants. It is important to study the effects on growth and health outcomes in infants who are fed formulae based on these newly developed hydrolysates as compared to those fed standard intact protein formulae or breastmilk. The overall aims of the current study are to evaluate the effects of two new hydrolysates on growth, immunological biomarkers, neurodevelopment, protein metabolism and gut microbiota in a randomized, controlled clinical trial of healthy infants. In compliance with European Food Safety Authority (EFSA) regulations for novel infant formulas based on hydrolysed protein, the primary outcome is change in weight standard deviation score (SDS) from baseline until 5 months of age.
Objective：The aim of this trial is to assess effects of Kieember and Yashili infant formula on body growth, behavior development, intestinal comfort, infectious diseases, allergic diseases, the absorption of nutrients and gut microbiota as compared to breast-milk in term infants aged 0-3 months. Participants：150 healthy term infants aged less than 30 days at entry to study. Study Design: A open-label,parallel, controlled trial. Arms, Groups, and Intervention: (1) Breast milk-fed group: fed with human breast milk; (2) Breast Milk Simulated Formula Group：fed with breast milk simulated infant formula (Ruibuen®Kieember, Phase I); (3) Traditional Formula Group: fed with traditional infant formula (Ruibuen®Yashili, Phase I). Intervention Duration: 90 days. Visits: 1month and 3month old. Outcome measures: (1)Biochemical detection of feces (total fat, fatty acids, calcium, nitrogen);(2)Stool characteristics (frequency, color, volume, and stool consistency);(3)Anthropometric parameters (body length, body weight, and head circumferences);(4)Temperament and adaptive behavior;(5)Gut microbiota;(6)General health and wellbeing;(7)concomitant medications and adverse events.
Rationale: Results from a previous study suggest that gastric layer formation, which is caused by emulsion instability as a result of gastric acidification/digestion, is different between breastmilk and infant formula. The current study focusses on further understanding of these differences by investigating the effect of formula composition. Objective: To investigate the effect of infant formula composition on intragastric behavior, gastric emptying and postprandial plasma parameters. Study design: Double-blind cross-over study with two treatments. Study population: 20 healthy normal-weight males, aged 18-45 y. Intervention: After an overnight fast, participants will drink sufficient volume of one of the two IFs which differ in composition. Gastric content will be monitored using Magnetic Resonance Imaging (MRI). MRI scans will be done and blood samples will be taken for subsequent analyses at baseline and post prandially . Main study parameters/endpoints: The primary outcome is gastric behavior. Secondary outcomes are total gastric content volume over time and blood parameters. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks associated with participation are low, as both phlebotomy and MRI are eminently safe medical techniques. In addition, the test formula are safe. Each participant will participate in 2 sessions, which require an overnight fast, 9 blood withdrawals (in total 120 mL per visit) and multiple MRI scans over a period of approximately 2 hours. These measurements are non-invasive and carry minimal risk. The burden of the sessions is most likely related to mild discomfort as they have to lie still in the MRI for two hours. This will be minimized by the soft mattress on the bed of the MRI, leg rest and a pillow underneath the head.
Gastrointestinal tolerability of a partially hydrolyzed, whey-based, ready-to-feed infant formula in healthy newborns during the birth hospitalization period: a post-market study
The primary objective of this study is to investigate if consumption of lower protein formula can slow the rate of weight gain of formula-fed infants between 3 and 12 months of age. Secondary objectives include investigation into whether infant nutrition and growth have an impact on later risk of obesity and cardiovascular disease.
The primary hypothesis is that Lactobacillus paracasei ssp. paracasei strain F19 in an infant formula containing FOS/GOS is safe and tolerable for use in infants from 0 to 6 months.
This study, conducted at the University of Pennsylvania s Newborn Nursery, the Children s Hospital of Philadelphia, and the Exton Specialty Care Center, will examine how different infant diets may affect estrogen activity in babies. During pregnancy, babies are exposed to the female hormone estrogen from their mother. Estrogen plays a key role in the development of breasts and milk production, as well as the development of the uterus. The effects of these hormones can be seen when babies are examined. Between 6 and 12 months of age, the effects are reduced. Breast milk and some infant formulas may contain compounds that can act like female hormones in the body and may prolong the estrogen effects. This study has two parts. Part 1 studies the physical development of babies fed different ways. Part 2 studies how hormone levels in babies differ depending on what they are being fed. Babies may participate in one or both parts. Part 1 includes babies 0 to 6 months of age; part 2 includes babies 0 to 12 months of age. In each part of the study, parents may choose to have their babies evaluated from one to four times. Full-term infants (age 37 to 41 weeks gestational age) from birth to 12 months of age who weigh from 2501 to 4499 grams (about 5.5 to 10 pounds) at birth and who have no chromosomal abnormalities, major malformations, or endocrine problems may be eligible for this study. Male infants must have palpable testes. Infants being fed a diet of breast milk, soy milk, or cow s milk will be included. Study procedures include the following: Part 1 - Feeding history: the parent provides information about the baby s dietary intake since birth. - Length, weight, and head circumference: the baby s measurements are taken. - Physical examination: the baby s physical maturity is assessed by examination of the skin, breasts, and external sex organs. - Breast secretions: the baby s breast buds are gently pressed during the physical examination to look for a milky-white substance that some babies produce during the first year of life. If the substance appears, a specimen will be collected. - Vaginal cells: for baby girls, the opening of the vaginal area is gently swabbed with a sterile Q-tip to assess the maturity of the vaginal lining. Part 2 - Feeding history and length, weight and head circumference measurements as described above. - Urine: a urine sample is collected in a cotton diaper or a urine collection bag. - aliva: a saliva sample is collected by gently swabbing the inside of the baby s mouth 1 hour after a morning feeding to remove any left over milk. - Hair: a lock of hair, 1/2-inch wide and 1 to 2 inches long is taken from 12-month old babies. - Blood: some infants have a small blood sample collected by a heel-stick. This study will serve as a basis for a later study about how infant formulas affect infant growth.