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Clinical Trial 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.


Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01956682
Study type Interventional
Source University of Bari
Contact
Status Completed
Phase Phase 4
Start date October 2014
Completion date March 2015

See also
  Status Clinical Trial Phase
Completed NCT03371615 - Evaluation of the Tolerance and Safety of a New Partly Fermented Anti-regurgitation Infant Formula N/A
Active, not recruiting NCT05363553 - Transition to Infant Formula Feeding on Gastrointestinal Regurgitation (TIGER) Study N/A
Completed NCT04042454 - To Assess the Safety and Tolerance of Infant Formula With Locust Bean Gum in Infants With Regurgitation N/A