An interventional study of Experimental Infant formula and Infant formula thickened with locust bean gum in Gastroesophageal Reflux in Children, sponsored by United Pharmaceuticals. Recruiting at 12 sites in 4 countries. Open to participants aged 2 Weeks to 4 Months. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by United Pharmaceuticals · Not applicable, Interventional, and Treatment
The aim of the study is to assess the effectiveness of this new formula on regurgitations and secondarily its effect on digestive tolerance through a randomized, controlled, double-blind trial against a comparator.
The study duration is 1 month and 2 days. It is possible to add 2 additional months (optional).
The 2 first days (from D-3 to D0) correspond to the pre-selection period. These 2 days are followed by the follow-up month (from D0 to D30). It is possible to add an optional follow up of 2 months (form D30 to D90).
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's planned enrollment of 346 is above the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →United Pharmaceuticals is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
new thickened infant formula containing fibres
Other: Experimental Infant formula
infant formula thickened with locust bean
Other: Infant formula thickened with locust bean gum
Exclusive formula feeding with the new infant formula thickened with fibers
Exclusive formula feeding with the formula thickened with locust bean
Frequency of regurgitation
Decrease of the daily number of regurgitation between baseline and day 14
Time frame: Day 14
Frequency of regurgitations
Change in the daily number of regurgitation between baseline and day 30 / day 90
Time frame: Day 30, Day 90
Severity of regurgitation episodes
Severity of regurgitations will be assessed using the adapted Vandenplas' score (range: 0 to 6; higher scores indicate more severe regurgitation)
Time frame: Day 14, Day 30, Day 90
Stools' frequency
Average daily stool's number
Time frame: Day 14, Day 30, Day 90
Stools' consistency
The Amsterdam Infant Stool Scale (AISS) (consistency categories: A \[watery\] to D \[hard\]; higher categories indicate firmer stools)
Time frame: Day 14, Day 30, Day 90
Frequency of diarrhea
Frequency : Occurence of diarrhea
Time frame: Day 14, Day 30, Day 90
Severity of diarrhea
Severity of diarrhea assessed using a study-specific score calculated as the sum of the products of each watery stool and its volume over 2 days (minimum score: 6; no upper limit; higher scores indicate more severe diarrhea)
Time frame: Day 14, Day 30, Day 90
Frequency of constipation
Occurence of constipation
Time frame: Day 14, Day 30, Day 90
Severity of constipation
Severity of constipation assessed using a study-specific score (range: 1 to 3; higher scores indicate more severe constipation)
Time frame: Day 14, Day 30, Day 90
Crying time
Crying time reported by parents in class (Min : Less than 10 min / Max : 3h or more)
Time frame: Day 14, Day 30, Day 90
Feeding refusal
Percentage of parents reporting feeding refusal by frequency of occurence (Never / Rarely / Sometimes / Often / Always)
Time frame: Day 14, Day 30, Day 90
Abnormal posturing
Percentage of parents reporting abnormal posturing by frequency of occurence (Never / Rarely / Sometimes / Often / Always)
Time frame: Day 14, Day 30, Day 90
Sleep quality
Percentage of parents reporting poor sleep quality (Excellent / Good / Fair / Poor)
Time frame: Day 14, Day 30, Day 90
Anthropometric parameters - Weight
Body weight measured in kilograms (kg)
Time frame: Day 14, Day 30, Day 90
Anthropometric parameters - Length
Body length measured in centimeters (cm)
Time frame: Day 14, Day 30, Day 90
Anthropometric parameters - Head circumference
Head circumference measured in centimeters (cm)
Time frame: Day 14, Day 30, Day 90
Anthropometric parameters - BMI
Body mass index calculated as kg/m²
Time frame: Day 14, Day 30, Day 90
Anthropometric parameters - Weight-for-height z-score
Weight-for-height z-score calculated according to WHO Child Growth Standards
Time frame: Day 14, Day 30, Day 90
Use of drug treatments
Frequency of use of proton-pump inhibitors, prokinetics, other GERD treatment
Time frame: Day 14, Day 30, Day 90
Parents' satisfaction
Parental satisfaction assessed using a 5-point Likert scale (Very satisfied, Fairly well satisfied, Somewhat dissatisfied, Very dissatisfied, No opinion)
Time frame: Day 14, Day 30, Day 90
Investigator's satisfaction
Investigator satisfaction assessed using a 5-point Likert scale (Very satisfied, Fairly well satisfied, Somewhat dissatisfied, Very dissatisfied, No opinion)
Time frame: Day 14, Day 30, Day 90
Plan to share: No
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United Pharmaceuticals