Baby Formula and Health

University of Rochester

Status: Completed

Conditions: Pancreas Disease

Study type: Observational

Funder types: Other

Identifiers

NCT04559490

STUDY00004724

Details and patient eligibility

About

The purpose of this study is to learn about how different types of carbohydrates used in infant formula may affect a baby's intestines and pancreas.

Enrollment: 22 patients

Sex: All

Ages: 5+ months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Mothers ≥ 19 years of age
• Singleton birth
• Healthy Infants
• Infant between 3-6 months at the time of visit and exclusively fed one of the formulas for a minimum of 3 months

Exclusion criteria

• Delivery before 35 weeks
• Infant birth weight <2500g
• Infants exhibiting growth faltering (loss of more than 25 percentile points) between 1 month to the time of study visit for either weight or length.
• Infant medical or genetic indications that would impact normal feeding behavior, insulin signaling or growth patterns.
• Infant consumption of more than two servings of complementary foods per day before the study visit.

Trial design

22 participants in 2 patient groups

Standard formula

Description:

Participants receiving intact protein lactose-based formula, exclusively for at least 3 months.

Sensitive

Description:

Participants receiving intact protein glucose/sucrose- based formula, exclusively for at least 3 months.