To Assess the Safety and Tolerance of Infant Formula With Locust Bean Gum in Infants With Regurgitation

Study Overview
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Brief Summary
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A randomized, controlled study to evaluate the safety and tolerance of an infant formula with locust bean gum in infants with regurgitation. (Solar)

Official Title
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A Randomized, Controlled Study to Evaluate the Safety and Tolerance of an Infant Formula With Locust Bean Gum in Infants With Regurgitation

Conditions
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Regurgitation, Gastric, Diarrhea

Intervention / Treatment
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* Other: milk based anti-regurgitation infant formula
* Other: Milk based infant formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton infants with regurgitation who are otherwise healthy Diagnosed with regurgitation according to the (adapted) Rome IV diagnostic criteria. Term infants with a gestational age at birth of ≥37 weeks + 0 days and ≤41 weeks + 6 days Aged > 3 weeks (21 days) and < 9 weeks (63 days) at screening Exclusively formula fed for ≥ 7 days before screening Written informed consent from the parent(s) and/or legally acceptable representative(s) Exclusion Criteria: Low birth weight for gestational age and gender Infants diagnosed with or suspected to have gastroesophageal reflux disease (GERD). I 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 Infants who already consumed a thickened anti-regurgitation (AR) formula or used thickening supplements Infants who already started complementary feeding Infants with a gastrointestinal infection within 4 weeks prior to screening 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 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 Infants known or suspected to have allergy to cow's milk protein Presence of any other gastrointestinal symptom(s)/disorder(s) that are not functional in nature, as assessed by the investigator's clinical judgement Participation in any other studies involving investigational or marketed products concomitantly or prior to screening 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

Ages Eligible for Study
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Minimum Age: 3 Weeks
Maximum Age: 9 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Product<br>Cow's milk-based infant formula containing the thickener locust bean gum containing prebiotic oligosaccharides and postbiotics | Other: milk based anti-regurgitation infant formula<br>* 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.<br>|
| Active Comparator: Control Product<br>Cow's milk-based infant formula containing prebiotic oligosaccharides and postbiotics | Other: Milk based infant formula<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average stool consistency | 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the average stool consistency | 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 | 8 weeks | 
| The average stool frequency | 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 | 8 weeks | 
| Incidence of diarrhoea: | 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) based on investigator's diagnosis of diarrhoea (throughout the entire study) | 8 weeks, 17 weeks | 
| IGSQ sum and individual item scores | IGSQ sum and individual item scores, adjusted for baseline, at 2, 4 and 8 weeks of intervention, and at the age of 17 weeks | 2, 4, 8, 17 weeks | 
| Gut microbiota composition and function | Gut microbiota composition and function (acetate, lactate, pH, calprotectin, ammonium and sIgA) at baseline and at the age of 17 weeks | 17 weeks | 
| Regurgitation | 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) | 2,4,8,17 weeks |