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

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