Treatment Trials

118 Clinical Trials for Various Conditions

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RECRUITING
Infant Formula in Infants and Children With Cow's Milk Allergy
Description

This is a multi-center, randomized, double-blinded, placebo-controlled food challenge to be conducted in infants and children with confirmed IgE-mediated cow's milk allergy (CMA), followed by a 7-day open feeding of the experimental formula.

RECRUITING
Goat or Cow Milk Based Infant Formula GMS
Description

This study is a non-inferiority, decentralized, randomized, double-blind, controlled clinical trial evaluating the growth, tolerance, and safety of a goat's-milk test infant formula (Test Formula 1; TF1) and a cow's-milk test infant formula (Test Formula 2; TF2), each compared to a cow's-milk infant formula commercially available in the United States (Control Formula; CF).

Conditions
ACTIVE_NOT_RECRUITING
Comparison of Growth and Tolerance of Healthy Term Infants Fed Iron-Fortified Infant Formulas
Description

A 4 month growth monitoring study of healthy term infants fed iron fortified infant formula. Infants will be fed ad-libitum for 16 weeks and growth will be evaluated in terms of weight gain over the 16 weeks.

RECRUITING
Growth, Tolerance, and Safety Study of Healthy Term Infants Consuming a New Organic Cow's Milk-Based Infant Formula
Description

The goal of this study is to demonstrate that healthy term babies who are fed Bobbie's study formula grow at the same rate as those fed with an existing cow's milk formula. Breastfeeding is the ultimate reference for infant nutrition. Therefore, this study also includes a group of breastfed babies for additional comparison.

Conditions
COMPLETED
Growth and Safety Clinical Trial on a New Infant Formula
Description

The aim of this study is to assess age-appropriate growth of healthy infants fed a new infant formula. In this randomized, controlled trial, healthy, term, formula-fed infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants or the new infant formula for term infants for 16 weeks. A reference group of human milk-fed infants will also be enrolled. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. This study allows caregivers to participate completely from the comfort of their own home.

Conditions
COMPLETED
Infants Fed a Hydrolyzed Infant Formula
Description

The purpose of this non-randomized, multi-center study is to evaluate the growth, tolerance and compliance of an extensively hydrolyzed infant formula in an intended use population of infants.

UNKNOWN
Infant Formula Feeding and Necrotizing Enterocolitis in Newborns
Description

Necrotizing enterocolitis (NEC) is the most common life-threatening gastrointestinal emergency of prematurity, associated with a significant morbidity and mortality. Early diagnosis and early treatment interventions may reduce the risk of mortality and morbidity. The Primary goal of this observational study is to gather survey data to establish a national database of NEC in newborns in order to better understand the risk factors underlying NEC. Survey data will be used along with a medical history to identify the mechanism(s) underlying the increased prevalence of NEC in non-breast fed, formula fed premature infants.

COMPLETED
Growth and Tolerance of a Partially Hydrolyzed Infant Formula
Description

The purpose of this research study is to compare the growth and tolerance of infants who consume either an infant formula with intact proteins or an infant formula with partially hydrolyzed proteins through approximately 12 months of age.

Conditions
ACTIVE_NOT_RECRUITING
Infant Formula and Toddler Drink Feeding Study
Description

The purpose of this study is to evaluate the growth and development outcomes of infants fed a new infant formula and toddler drink through 24 months of age.

Conditions
TERMINATED
Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy
Description

This is a multi-center, randomized, double-blind, placebo-controlled food challenge to be conducted in infants or children with confirmed IgE-mediated cow's milk allergy (CMA), followed by a 7-day open feeding of the experimental formula.

COMPLETED
Growth and Safety Clinical Trial on a New Infant Formula.
Description

The aim of the study is to assess age-appropriate growth of healthy infants fed a new organic milk-based infant formula.

Conditions
COMPLETED
Phase II Growth and Safety Study of an Infant Formula for Healthy Term Infants
Description

A goal of infant formula development is to mimic human milk (HM) both in nutrient composition as well as physiologic outcomes. investigators have developed an infant formula for term infants that more closely resembles the composition of human milk. The purpose of this study is to demonstrate that this formulation meets nutritional requirements and supports age appropriate growth of healthy term infants.

COMPLETED
Healthy Term Infants Fed Milk-Based Infant Formula
Description

This is a randomized, controlled, double-blind, parallel, feeding study with the purpose to evaluate the tolerance of healthy term infants fed partially hydrolyzed whey protein infant formulas.

Conditions
TERMINATED
Infant Formula and Toddler Drink Feeding Intervention
Description

The purpose of this randomized, multi-center, controlled, double-blind, parallel study is to evaluate the health and developmental outcomes of children fed a new infant formula and toddler drink through 24 months of age.

COMPLETED
Follow-up Study of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants
Description

The purpose of this two-month follow-up study is to continue to follow growth, safety, and other health outcomes of infants fed a new infant formula for term infants or comparator formula. A reference group of human milk-fed infants will also be followed. This study is designed in accordance with Good Clinical Practice guidelines.

COMPLETED
Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants
Description

The purpose of this study is to demonstrate that a new infant formula for term infants supports age-appropriate growth. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. In this randomized, controlled trial (RCT), healthy, term, formula-fed (FF) infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants (CF) or the study formula for term infants (SF) for 16 weeks. A reference group of human milk-fed infants will also be enrolled. The primary efficacy objective is to compare the growth of infants randomized to the study infant formula (SF) versus growth of infants randomized to the standard commercial infant formula (CF).

Conditions
COMPLETED
Growth and Tolerance of Young Infants Fed Infant Formula
Description

This is a randomized, multicenter, controlled, double-blind, parallel study to evaluate growth and tolerance of healthy term infants fed milk-based infant formulas.

TERMINATED
Growth and Tolerance Trial on Infant Formula With HMO
Description

The aim of the study is to compare growth of healthy infants fed an infant formula supplemented with a human milk oligosaccharide to that of infants on standard formula.

Conditions
TERMINATED
Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas
Description

This clinical trial will compare stool and oral microbiome composition between infants fed breast milk or one of two infant formulas for a 60 day feeding period.

COMPLETED
Infants Fed Extensively Hydrolyzed Casein-Based Infant Formulas
Description

This is a randomized, controlled, double-blind, multicenter parallel study to evaluate the growth, tolerance and compliance of healthy infants fed infant formulas with extensively hydrolyzed casein protein.

COMPLETED
Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula
Description

This single-group study will assess growth and tolerance of infants fed a post-discharge preterm infant formula containing a prebiotic.

COMPLETED
Growth and Tolerance of Infants Fed Milk-Based Infant Formula
Description

The purpose of this study is to evaluate growth and tolerance of healthy term infants fed an experimental milk-based infant formula with oligosaccharides compared to a control milk-based infant formula.

COMPLETED
Evaluation of Infants Fed an Extensively Hydrolyzed Infant Formula
Description

This is a single group, non-randomized, multicenter study to assess the effects of a hypoallergenic casein hydrolysate powdered infant formula on gastrointestinal (GI) tolerance, growth and compliance in an intended use infant population.

COMPLETED
Impact of Infant Formula on Caregiver-perceived Intolerance
Description

Understand the impact of switching to a commercially available infant formula on gastrointestinal symptoms

Conditions
COMPLETED
Role of Low Lactose Infant Formula In The Management of Neonatal Abstinence Syndrome
Description

Currently Morphine and or Methadone are the most commonly used drugs in the treatment for NAS along with supportive care. Many care providers offer tolerance "low lactose" formula to these infants to alleviate gastrointestinal symptoms. There are no clinical studies to support this practice and it is currently unknown that low lactose formula really helps or not in management of NAS. This is a Randomized Double Blind Clinical Trial to assess the role of low lactose formula versus standard (regular) formula in managing NAS.

COMPLETED
Growth and Safety Study of an Infant Formula for Healthy Term Infants
Description

A goal of infant formula development is to mimic human milk (HM) both in nutrient composition as well as physiologic outcomes. investigators have developed an infant formula for term infants that more closely resembles the composition of human milk. The purpose of this study is to demonstrate that this formulation meets nutritional requirements and supports age appropriate growth of healthy term infants.

COMPLETED
Gastrointestinal Tolerance Evaluation of an Infant Formula
Description

Prospective, double-blind, randomized study of 2 infant formulas.

COMPLETED
Acceptance Of A Partially-Hydrolyzed Infant Formula
Description

This clinical trial will evaluate stool consistency in infants receiving one of two study formulas through a 14-day feeding period.

Conditions
COMPLETED
Addition to Infant Formula of 2-fucosyllactose (2-FL)
Description

OBJECTIVES: Primary: The primary objective is to determine whether the mean weight gain over a 16-week interval starting on or before 14 days of life differs between infants fed one of two infant formulas as their sole source of nutrition: a commercial formula using a canola l fat blend (Control, E23) or the same formula containing the human milk oligosaccharide (Test (HMO) 2-fucosyllactose (2FL). Mean weight gain also will be compared to that of a concurrently enrolled reference group of exclusively breastfed infants.

COMPLETED
A Study to Monitor the Use of an Amino Acid-Based Infant Formula
Description

To assess the frequency and nature of adverse events in infants fed a free amino acid based infant formula.