Status:
COMPLETED
To Assess the Safety and Tolerance of Infant Formula With Locust Bean Gum in Infants With Regurgitation
Lead Sponsor:
Nutricia Research
Conditions:
Regurgitation, Gastric
Diarrhea
Eligibility:
All Genders
3-9 years
Phase:
NA
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)
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2023
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT04042454
Start Date
December 10 2019
End Date
May 23 2023
Last Update
July 13 2023
Active Locations (16)
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1
A.O.U. Ospedali Riuniti di Ancona
Ancona, Italy
2
Ospedale pediatrico Giovanni XXIII
Bari, Italy
3
Azienda Ospedaliera Universitaria G. Martino
Messina, Italy
4
Ospedale dei bambini Buzzi
Milan, Italy