Efficacy and Tolerance of a Follow-On Formula Fed to Children From 36-48 Months of Age
1 other identifier
interventional
310
1 country
1
Brief Summary
The purpose is to determine if the consumption of study product has an effect on acute respiratory infections and/or diarrheal disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 5, 2011
CompletedFirst Posted
Study publicly available on registry
December 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedDecember 6, 2012
December 1, 2012
7 months
December 5, 2011
December 5, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Acute respiratory infections and diarrheal disease
28 weeks
Secondary Outcomes (12)
Allergic manifestations
28 weeks
Systemic antibiotic use
28 weeks
Duration of acute respiratory infection and diarrheal disease
28 weeks
Changes in stool patterns
Baseline and 28 weeks
Fecal immune markers
Baseline and 28 weeks
- +7 more secondary outcomes
Study Arms (2)
Cow's Milk
PLACEBO COMPARATORPowdered whole cow's milk
Follow-On Formula
EXPERIMENTALPowdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide
Interventions
Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide
Eligibility Criteria
You may qualify if:
- Child 36-48 months of age
- Child is currently attending a daycare and has attended for 6 months or less
- Has consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to randomization
- Signed informed consent
You may not qualify if:
- Child who received any food product or supplement containing probiotics or prebiotics in the 15 days prior to randomization
- Child with allergy to gluten or serious concurrent illness that will interfere in the general management of the child
- Child with diarrhea or acute respiratory infection during the 48 hours prior to randomization
- Child's z-score of weight for height \< -3 according to World Health Organization criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mead Johnson Nutritionlead
- Shanghai Children's Medical Centercollaborator
- Shanghai, Chinacollaborator
Study Sites (1)
Shi-ji-xing Child Care Center, Jin Dong District
Jinhua, Zhejiang, 321000, China
Related Publications (1)
Li F, Jin X, Liu B, Zhuang W, Scalabrin D. Follow-up formula consumption in 3- to 4-year-olds and respiratory infections: an RCT. Pediatrics. 2014 Jun;133(6):e1533-40. doi: 10.1542/peds.2013-3598. Epub 2014 May 19.
PMID: 24843061DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xingming Jin, M.D.
Professor of Development and Behavioral Pediatrics, Shanghai Children Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2011
First Posted
December 8, 2011
Study Start
November 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
December 6, 2012
Record last verified: 2012-12