NCT04042454CompletedNot Applicable
A Randomized, Controlled Study to Evaluate the Safety and Tolerance of an Infant Formula With Locust Bean Gum in Infants With Regurgitation
Nutricia Research16 sites in 3 countries103 target enrollmentStarted: December 10, 2019Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 103
- Locations
- 16
- Primary Endpoint
- Average stool consistency
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 3 Weeks to 9 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Test Product
Experimental
Cow's milk-based infant formula containing the thickener locust bean gum containing prebiotic oligosaccharides and postbiotics
Intervention: milk based anti-regurgitation infant formula (Other)
Control Product
Active Comparator
Cow's milk-based infant formula containing prebiotic oligosaccharides and postbiotics
Intervention: Milk based infant formula (Other)
Outcomes
Primary Outcomes
Average stool consistency
Time Frame: 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 Outcomes
- IGSQ sum and individual item scores(2, 4, 8, 17 weeks)
- To assess the average stool consistency(8 weeks)
- The average stool frequency(8 weeks)
- Incidence of diarrhoea:(8 weeks, 17 weeks)
- Gut microbiota composition and function(17 weeks)
- Regurgitation(2,4,8,17 weeks)
Investigators
Study Sites (16)
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