Hypoallergenic Infant Formula Containing Starch and the Probiotic: Effect on Gastric Emptying
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- Regurgitation
Study Overview
Brief Summary
The primary objective of this trial is to show that an hypoallergenic infant starter formula containing starch and the probiotic L. reuteri decreases the severity of regurgitation/spitting-up in infants presenting regurgitation/spitting-up , and who have taken it for 4 weeks, in comparison with a standard infant starter formula.
Detailed Description
The primary objective of this trial is to show that the test formula (HA formula + starch + L. reuteri) decreases the severity (frequency + volume) of regurgitation/spitting-up in infants and ultrasound gastric emptying time, compared to a classical infant starter formula.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 5 Days to 5 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Full term infant (37 weeks ≤ gestation ≤ 42 weeks)
- •Age of infant between 5 days and 5 months
- •Infant exclusively formula-fed at enrollment
- •Presenting regurgitation/spitting-up according to the parents' perception
- •Vandenplas score of at least 2 and maximum 5
- •Having obtained the subject's legal representative's written informed consent
Exclusion Criteria
- •Previous antireflux treatment
- •Previous consumption of AR infant formula or external thickener
- •Previous consumption of a formula with L. reuteri
- •Cow's milk allergy symptoms according to medical decision
- •Congenital illness or malformation that may affect growth
- •Significant pre-natal and/or post-natal disease
- •Newborn whose parents / caregivers cannot be expected to comply with study procedures
- •Newborn currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.
Arms & Interventions
Infant formula
HA formula + starch + L. reuteri
Intervention: HA formula + starch + L. reuteri (Dietary Supplement)
Standard Formula
Standard Infant Formula
Outcomes
Primary Outcomes
Regurgitation
Time Frame: four weeks of treatment
The primary outcome is the difference in the proportions of improved subjects at four weeks of treatment between the treatment and control groups.
Secondary Outcomes
- Regurgitation score(Four weeks treatment)
- Stool frequency(Four weeks treatment)
- compliance(four weeks intervention)
- Growth(Four weeks of treatment)
- Gastric empty rate(Four week treatment)
- Financial and non-financial burden(Four week treatment)
- Digestive tolerance(Four weeks treatment)
Investigators
Flavia Indrio
M.D.
University of Bari