Assessing Early Behavioral Indicators of Formula Tolerance
1 other identifier
interventional
71
1 country
1
Brief Summary
The study is intended to assess the amount of crying and fussiness in infants fed an infant formula containing probiotics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 6, 2015
CompletedFirst Posted
Study publicly available on registry
January 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedSeptember 14, 2016
September 1, 2016
1.6 years
January 6, 2015
September 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Infant Behavior Diary
21 Days
Secondary Outcomes (6)
Recall of Tolerance Questionnaire
Baseline and Day 21
Body Weight
Baseline and Day 21
Infant Behavior Questionnaire - Revised
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
- +1 more secondary outcomes
Study Arms (2)
Control
ACTIVE COMPARATORMarketed partially hydrolyzed cow's milk protein infant formula
Investigational
EXPERIMENTALPartially hydrolyzed cow's milk infant formula with a probiotic
Interventions
Partially hydrolyzed cow's milk protein infant formula with a probiotic
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mead Johnson Nutritionlead
- Baylor College of Medicinecollaborator
Study Sites (1)
Children's Nutrition Research Center
Houston, Texas, 77030, United States
Related Publications (1)
Shulman RJ, Chichlowski M, Orozco FG, Harris CL, Wampler JL, Bokulich NA, Berseth CL. Infant behavioral state and stool microbiome in infants receiving Lactocaseibacillus rhamnosus GG in formula: randomized controlled trial. BMC Pediatr. 2022 Oct 7;22(1):580. doi: 10.1186/s12887-022-03647-x.
PMID: 36207675DERIVED
Study Officials
- STUDY DIRECTOR
Carol Lynn Berseth, M.D.
Mead Johnson Nutrition
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2015
First Posted
January 16, 2015
Study Start
January 1, 2015
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
September 14, 2016
Record last verified: 2016-09