Status:
COMPLETED
GI Tract Biomarkers in Infants With Different Diets
Lead Sponsor:
Nemours Children's Clinic
Collaborating Sponsors:
University of Delaware
Conditions:
Obesity, Childhood
Eligibility:
All Genders
6-3 years
Brief Summary
Childhood obesity is increasing with more than one-third of adolescents currently overweight and one in five with obesity. The lifelong incidence of obesity-related morbidities is also increasing with...
Eligibility Criteria
Inclusion
- Otherwise healthy, male or female term infants
- Exclusively breast or formula feeding
- Never been exposed to oral or intravenous antibiotics or probiotics
Exclusion
- Maternal antibiotic use while breast-feeding
- Infant or maternal use of probiotics
- Current or recent (\<14 days) gastrointestinal infection (viral, bacterial, or fungal)
- Gastrointestinal mucosal disease, or significant constipation
- Consuming formula that is not standard cow's milk formula
- Infants on acid suppression medications or infants receiving high-density formula (\>20 calories/ounce) may be enrolled and will be analyzed separately
Key Trial Info
Start Date :
March 10 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 30 2025
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03751137
Start Date
March 10 2016
End Date
May 30 2025
Last Update
June 4 2025
Active Locations (1)
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1
Nemours Children's Hospital - Delaware
Wilmington, Delaware, United States, 19803