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NCT00655720 Clinical Trial

The Effects on Growth of a Non-Routine Infant Formula

Growth Clinical Trial

Official title:
The Effects on Growth and Tolerance of Hydrolyzed Formulas Fed to Term Infants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00655720
Other study ID # 3369-5
Secondary ID 3369-5
Status Completed
Phase N/A
First received March 28, 2008
Last updated April 10, 2008
Start date March 2006
Est. completion date May 2007

Study information
Verified date April 2008
Source Mead Johnson Nutrition
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

A study to evaluate the growth and development of term infants fed either an extensively hydrolyzed formula with probiotics, a partially hydrolyzed formula with probiotics, or an extensively hydrolyzed formula without probiotics

Recruitment information / eligibility
Status Completed
Enrollment 293
Est. completion date May 2007
Est. primary completion date May 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 16 Days
Eligibility Inclusion Criteria:

- Term infant

- Solely formula fed

- 14 days of age

Exclusion Criteria:

- History of underlying disease

- Evidence of formula intolerance

- Current illness

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

Intervention

Other:
• infant formula
hydrolyzed infant formula without probiotics hydrolyzed infant formula with probiotics hydrolyzed infant formula with probiotics

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Mead Johnson Nutrition

Outcome
Type Measure Description Time frame Safety issue
Primary Growth (weight) 106 days Yes
Secondary Tolerance 106 days No
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Completed NCT01210391 - Growth of Infants Fed an Extensively Hydrolyzed Infant Formula N/A
Completed NCT01158352 - Study to Evaluate the Effect of Short Treatment With Nutritional Supplementation Standardized Innovative Formula, on Growth and Weight Gain in Short and Lean Prepubertal Children N/A