Trials / Completed
CompletedNCT01956682
Hypoallergenic Infant Formula Containing Starch and the Probiotic: Effect on Gastric Emptying
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 132 (actual)
- Sponsor
- University of Bari · Academic / Other
- Sex
- All
- Age
- 5 Days – 5 Months
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | HA formula + starch + L. reuteri |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2015-03-01
- Completion
- 2015-03-01
- First posted
- 2013-10-08
- Last updated
- 2015-04-01
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT01956682. Inclusion in this directory is not an endorsement.