A Phase 4 interventional study of HA formula + starch + L. reuteri in Regurgitation, Gastric, sponsored by University of Bari. Completed at 1 site in Italy. Open to participants aged 5 Days to 5 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-01.
Sponsored by University of Bari · Phase 4, Interventional, and Treatment
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.
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.
56 studies on the registry are indexed under Laryngopharyngeal Reflux; 9 are open to participants now.
This study's enrollment of 132 is above the median of 72 across 37 interventional studies indexed under Laryngopharyngeal Reflux.
Browse Laryngopharyngeal Reflux studies →University of Bari is the lead sponsor of 75 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
HA formula + starch + L. reuteri
Dietary Supplement: HA formula + starch + L. reuteri
Standard Infant Formula
Regurgitation
The primary outcome is the difference in the proportions of improved subjects at four weeks of treatment between the treatment and control groups.
Time frame: four weeks of treatment
Growth
To assess whether the groups have comparable growth
Time frame: 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
Time frame: Four weeks treatment
Gastric empty rate
To compare the ultrasound gastric empty rate
Time frame: Four week treatment
Digestive tolerance
To assess the infants' digestive tolerance
Time frame: Four weeks treatment
Stool frequency
To assess stool frequency
Time frame: Four weeks treatment
compliance
To assess the subject's compliance to product consumption.
Time frame: four weeks intervention
Financial and non-financial burden
To measure family financial and non-financial burden related with the regurgitation
Time frame: Four week treatment
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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University of Bari