Regurgitation, Gastric
Conditions
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.
Interventions
DIETARY_SUPPLEMENTHA formula + starch + L. reuteri
Sponsors
University of Bari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Days to 5 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regurgitation | 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
| Measure | Time frame | Description |
|---|---|---|
| Regurgitation score | Four weeks treatment | To assess the severity of regurgitation/spitting-up To assess the frequency of regurgitation/spitting-up To assess the volume of regurgitation/spitting-up |
| Gastric empty rate | Four week treatment | To compare the ultrasound gastric empty rate |
| Digestive tolerance | Four weeks treatment | To assess the infants' digestive tolerance |
| Growth | Four weeks of treatment | To assess whether the groups have comparable growth |
| compliance | four weeks intervention | To assess the subject's compliance to product consumption. |
| Financial and non-financial burden | Four week treatment | To measure family financial and non-financial burden related with the regurgitation |
| Stool frequency | Four weeks treatment | To assess stool frequency |
Countries
Italy
Outcome results
None listed