Diarrhea, Regurgitation, Gastric
Conditions
Brief summary
A randomized, controlled study to evaluate the safety and tolerance of an infant formula with locust bean gum in infants with regurgitation. (Solar)
Interventions
OTHERmilk based anti-regurgitation infant formula
Cow's milk-based infant formula containing the thickener locust bean gum containing prebiotic oligosaccharides and postbiotics for a period of 8-14 weeks (dependent on infants age at baseline). The intervention last's until the infant's age of 17 weeks.
Cow's milk-based infant formula containing prebiotic oligosaccharides and postbiotics for a period of 8-14 weeks (dependent on infants age at baseline). The intervention last's until the infant's age of 17 weeks.
Sponsors
Nutricia Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Weeks to 9 Weeks
Healthy volunteers
Yes
Inclusion criteria
1. Singleton infants with regurgitation who are otherwise healthy 2. Diagnosed with regurgitation according to the (adapted) Rome IV diagnostic criteria. 3. Term infants with a gestational age at birth of ≥37 weeks + 0 days and ≤41 weeks + 6 days 4. Aged \> 3 weeks (21 days) and \< 9 weeks (63 days) at screening 5. Exclusively formula fed for ≥ 7 days before screening 6. Written informed consent from the parent(s) and/or legally acceptable representative(s)
Exclusion criteria
1. Low birth weight for gestational age and gender 2. Infants diagnosed with or suspected to have gastroesophageal reflux disease (GERD). I 3. Infants who received any of the following medication within 4 weeks prior to screening: systemic antibiotics, prokinetics and/or proton pump inhibitors and/or (other) medication to treat regurgitation 4. Infants who already consumed a thickened anti-regurgitation (AR) formula or used thickening supplements 5. Infants who already started complementary feeding 6. Infants with a gastrointestinal infection within 4 weeks prior to screening 7. Infants with a congenital condition, previous or current illness, and/or medication use that could interfere with the main study outcomes according to the investigator 8. Infants known or suspected to have: allergy for fish, soy protein, soy oil or corn; lactose intolerance; galactosaemia including history of any other allergic manifestations or known allergy to any of the study product ingredients and/or requiring a fibre-free diet 9. Infants known or suspected to have allergy to cow's milk protein 10. Presence of any other gastrointestinal symptom(s)/disorder(s) that are not functional in nature, as assessed by the investigator's clinical judgement 11. Participation in any other studies involving investigational or marketed products concomitantly or prior to screening 12. Incapability of the parent(s) to comply with the study protocol or investigator's uncertainty about the willingness or ability of the parent(s) to comply with the protocol requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average stool consistency | 8 weeks | The average stool consistency (based on the 4-point Brussels Infant and Toddler Stool Scale \[BITSS\]) of the 8th week of intervention, adjusted for the baseline stool consistency score. Catagories are hard stools, formed stools, loose stools and watery stools. https://bitss-stoolscale.com/ (assessed 31-Jan-19) can be used as a further reference. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the average stool consistency | 8 weeks | The average stool consistency based on the BITSS, adjusted for baseline, for every week until the 8th week of intervention and for the week prior to the age of 17 weeks |
| The average stool frequency | 8 weeks | The average stool frequency, adjusted for baseline, for every week until and including the 8th week of intervention and for the week prior to the age of 17 weeks |
| Gut microbiota composition and function | 17 weeks | Gut microbiota composition and function (acetate, lactate, pH, calprotectin, ammonium and sIgA) at baseline and at the age of 17 weeks |
| IGSQ sum and individual item scores | 2, 4, 8, 17 weeks | IGSQ sum and individual item scores, adjusted for baseline, at 2, 4 and 8 weeks of intervention, and at the age of 17 weeks |
| Regurgitation | 2,4,8,17 weeks | Regurgitation: number of regurgitation episodes per day and the regurgitation volume score, adjusted for baseline, at 2, 4 and 8 weeks of intervention, and at the age of 17 weeks (based on 3-day diaries) |
| Incidence of diarrhoea: | 8 weeks, 17 weeks | 1. based on the WHO criteria and derived from the BITSS, for every week (until and including week 8 of intervention, and at the age of 17 weeks) 2. based on investigator's diagnosis of diarrhoea (throughout the entire study) |
Countries
Italy, Poland, Ukraine
Outcome results
None listed