Gastroesophageal Reflux in Children
Conditions
Keywords
Reflux
Brief summary
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.
Detailed description
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).
Interventions
Exclusive formula feeding with the new infant formula thickened with fibers
OTHERInfant formula thickened with locust bean gum
Exclusive formula feeding with the formula thickened with locust bean
Sponsors
United Pharmaceuticals
Statitec
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Weeks to 4 Months
Healthy volunteers
No
Inclusion criteria
* ≥ 2 regurgitation episodes per day during the last 2 weeks and ≥ 4 regurgitation episodes per day in average during the last 2 days, * exclusive or predominant formula feeding * whose parents signed informed consent
Exclusion criteria
* preterm infants or birthweight \<2500g * Post enteritis lactose intolerance * Suspected or diagnosed cow's milk protein allergy requiring an eviction diet * Use of medications that may interfere with regurgitation or gastrointestinal transit (such as alginates, laxatives, antibiotics...). All these medications have to be stopped at least 7 days before inclusion visit (V1) * Infants presenting with any situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of regurgitation | Day 14 | Decrease of the daily number of regurgitation between baseline and day 14 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of regurgitations | Day 30, Day 90 | Change in the daily number of regurgitation between baseline and day 30 / day 90 |
| Severity of regurgitation episodes | Day 14, Day 30, Day 90 | Severity of regurgitations will be assessed using the adapted Vandenplas' score (range: 0 to 6; higher scores indicate more severe regurgitation) |
| Stools' frequency | Day 14, Day 30, Day 90 | Average daily stool's number |
| Stools' consistency | Day 14, Day 30, Day 90 | The Amsterdam Infant Stool Scale (AISS) (consistency categories: A \[watery\] to D \[hard\]; higher categories indicate firmer stools) |
| Frequency of diarrhea | Day 14, Day 30, Day 90 | Frequency : Occurence of diarrhea |
| Severity of diarrhea | Day 14, Day 30, Day 90 | 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) |
| Frequency of constipation | Day 14, Day 30, Day 90 | Occurence of constipation |
| Severity of constipation | Day 14, Day 30, Day 90 | Severity of constipation assessed using a study-specific score (range: 1 to 3; higher scores indicate more severe constipation) |
| Crying time | Day 14, Day 30, Day 90 | Crying time reported by parents in class (Min : Less than 10 min / Max : 3h or more) |
| Feeding refusal | Day 14, Day 30, Day 90 | Percentage of parents reporting feeding refusal by frequency of occurence (Never / Rarely / Sometimes / Often / Always) |
| Abnormal posturing | Day 14, Day 30, Day 90 | Percentage of parents reporting abnormal posturing by frequency of occurence (Never / Rarely / Sometimes / Often / Always) |
| Sleep quality | Day 14, Day 30, Day 90 | Percentage of parents reporting poor sleep quality (Excellent / Good / Fair / Poor) |
| Anthropometric parameters - Weight | Day 14, Day 30, Day 90 | Body weight measured in kilograms (kg) |
| Anthropometric parameters - Length | Day 14, Day 30, Day 90 | Body length measured in centimeters (cm) |
| Anthropometric parameters - Head circumference | Day 14, Day 30, Day 90 | Head circumference measured in centimeters (cm) |
| Anthropometric parameters - BMI | Day 14, Day 30, Day 90 | Body mass index calculated as kg/m² |
| Anthropometric parameters - Weight-for-height z-score | Day 14, Day 30, Day 90 | Weight-for-height z-score calculated according to WHO Child Growth Standards |
| Use of drug treatments | Day 14, Day 30, Day 90 | Frequency of use of proton-pump inhibitors, prokinetics, other GERD treatment |
| Parents' satisfaction | Day 14, Day 30, Day 90 | Parental satisfaction assessed using a 5-point Likert scale (Very satisfied, Fairly well satisfied, Somewhat dissatisfied, Very dissatisfied, No opinion) |
| Investigator's satisfaction | Day 14, Day 30, Day 90 | Investigator satisfaction assessed using a 5-point Likert scale (Very satisfied, Fairly well satisfied, Somewhat dissatisfied, Very dissatisfied, No opinion) |
Countries
Belgium, France, Greece, Italy
Contacts
CONTACTMagalie JEGAT
CONTACTANNE-SOPHIE GARREAU
Outcome results
None listed