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Effect of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Infants in China

Not Applicable
Completed
Conditions
Health Behavior
Personal Satisfaction
Registration Number
NCT01373541
Lead Sponsor
Enzymotec
Brief Summary

The purpose of this study is to determine the effect of infant formula with high percentage of palmitic acid at the sn-2 position (InFat™) on improving fat absorption and general gastrointestinal tolerance in Chinese formula-fed term infants.

Detailed Description

The purpose of this study is to assess the efficacy of infant formula with high percentage of palmitic acid at the sn-2 position (InFat™) as compared to standard vegetable oil based infant formula on general gastrointestinal tolerance and fat absorption, reducing calcium soaps formation and stool hardness in Chinese formula-fed term infants.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
171
Inclusion Criteria
  • Parental/legal guardian written informed consent;
  • The mother had unequivocally decided not to breast-feed (for formula fed infants) or to breastfeed (for human milk fed infants).
  • Term infant of Chinese origin born at 37-42 gestation weeks
  • Birth weight appropriate for gestational age (AGA), 2500-4000grams
  • The infant is apparently healthy at birth and entry of study.
Exclusion Criteria
  • Adverse maternal, fetal or infant medical history that can potentially affect efficacy parameters, tolerance, growth and/or development
  • The infant is not a singleton newborn

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Soaped and total fatty acids content in infant's stool samples collected at the age of 6 weeks and measured by stool biochemistry analysis6 postnatal weeks
Secondary Outcome Measures
NameTimeMethod
Number of participants with adverse events and concomitant medications as a measure of safety and tolerabilityBaseline, 6,12 and 24 postnatal weeks
Anthropometric parameters: body length, body weight, and head circumferences at each visitBaseline, 6, 12 and 24 postnatal weeks
Dietary, stool consistency and well being recorded by 3 day questionnaires6, 12 and 24 postnatal weeks
Bone speed of sound measured by ultrasonic device at each visitBaseline, 6,12 and 24 postnatal weeks

Trial Locations

Locations (1)

Rui Jin Hospital - Shanghai Jiao Tong University School of Medicine

🇨🇳

Shanghai, China

Rui Jin Hospital - Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China

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