NCT02340143CompletedNot Applicable
Assessing Early Behavioral Indicators of Formula Tolerance
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mead Johnson Nutrition
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- Infant Behavior Diary
Study Overview
Brief Summary
The study is intended to assess the amount of crying and fussiness in infants fed an infant formula containing probiotics.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 14 Days to 28 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Singleton at birth
- •Term infant with birth weight of 2500 g or more
- •Crying or fussing for 3 or more hours per day
- •Consuming mostly infant formula
- •Signed Informed Consent and Protected Health Information authorization
Exclusion Criteria
- •Current use of extensively hydrolyzed or amino acid infant formula
- •Planned use of probiotics during the study
- •History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
- •Enrollment in another interventional clinical research study
Arms & Interventions
Control
Active Comparator
Marketed partially hydrolyzed cow's milk protein infant formula
Intervention: Control (Other)
Investigational
Experimental
Partially hydrolyzed cow's milk infant formula with a probiotic
Intervention: Investigational (Other)
Outcomes
Primary Outcomes
Infant Behavior Diary
Time Frame: 21 Days
Secondary Outcomes
- Infant Behavior Questionnaire - Revised(Baseline and Day 21)
- Recall of Tolerance Questionnaire(Baseline and Day 21)
- Body Weight(Baseline and Day 21)
- Recall of formula intake at each visit(Baseline, Day 10, and Day 18)
- Fecal microbiome and Fecal calprotectin(Baseline and Day 21)
- Medically-confirmed Adverse Events(21 Days)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
The Evaluation of Infant Formulas Fed to Infants With Common Feeding ProblemsCommon Infant Feeding ProblemsNCT01934257Mead Johnson Nutrition296
Not yet recruiting
Not Applicable
to know the children emotions by assessing through emoji before during and after the dental treatmentCTRI/2022/01/039075Dr snehal ahire
Completed
Not Applicable
Growth and Tolerance of Infants Fed Infant FormulasGrowth and ToleranceNCT01808105Abbott Nutrition424
Completed
Not Applicable
The Evaluation of Cow Milk-Based FormulasTerm InfantsNCT00518414Mead Johnson Nutrition136
Completed
Not Applicable
Clock'N' Test: Development and Validation of a Test to Evaluate Emotional DisordersHealthyNCT03243370Centre Hospitalier Universitaire Dijon150