CompletedNot Applicable

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

Italy103 participantsStarted 2019-12-10

Plain-language summary

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

Age range3 Weeks – 9 Weeks

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)

✕. 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

Average stool consistency

Timeframe: 8 weeks

NCT IDNCT04042454

SponsorNutricia Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-23

Who can participate

Age range3 Weeks – 9 Weeks

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)

✕. 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