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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Regurgitation, Gastric

Intervention / Treatment
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* Dietary Supplement: HA formula + starch + L. reuteri


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Full term infant (37 weeks ≤ gestation ≤ 42 weeks) Age of infant between 5 days and 5 months NGA 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.

Ages Eligible for Study
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Minimum Age: 5 Days
Maximum Age: 5 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Infant formula<br>HA formula + starch + L. reuteri | Dietary Supplement: HA formula + starch + L. reuteri<br> <br> |
| Placebo Comparator: Standard Formula<br>Standard Infant Formula | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regurgitation | The primary outcome is the difference in the proportions of improved subjects at four weeks of treatment between the treatment and control groups. | four weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth | To assess whether the groups have comparable growth | Four weeks of treatment | 
| Regurgitation score | To assess the severity of regurgitation/spitting-up To assess the frequency of regurgitation/spitting-up To assess the volume of regurgitation/spitting-up | Four weeks treatment | 
| Gastric empty rate | To compare the ultrasound gastric empty rate | Four week treatment | 
| Digestive tolerance | To assess the infants' digestive tolerance | Four weeks treatment | 
| Stool frequency | To assess stool frequency | Four weeks treatment | 
| compliance | To assess the subject's compliance to product consumption. | four weeks intervention | 
| Financial and non-financial burden | To measure family financial and non-financial burden related with the regurgitation | Four week treatment |