MedTrace Logo

Hypoallergenic Infant Formula Containing Starch and the Probiotic: Effect on Gastric Emptying

NCT01956682 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2015-04-01

No results posted yet for this study

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.

Conditions

  • Regurgitation, Gastric

Interventions

DIETARY_SUPPLEMENT

HA formula + starch + L. reuteri

Sponsors & Collaborators

  • University of Bari

    lead OTHER

Principal Investigators

  • Flavia Indrio, MD · University of Bari

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Days
Max Age
5 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01956682 on ClinicalTrials.gov