Status:
COMPLETED
Evaluation of the Tolerance and Safety of a New Partly Fermented Anti-regurgitation Infant Formula
Lead Sponsor:
Nutricia Research
Conditions:
Regurgitation, Gastric
Eligibility:
All Genders
3-13 years
Phase:
NA
Brief Summary
A randomised, controlled, double-blind trial to evaluate the tolerance and safety of a new partly fermented anti-regurgitation infant formula containing prebiotics and locust bean gum in infants with ...
Eligibility Criteria
Inclusion
- Singleton healthy term infant aged 3 - 13 weeks;
- Gestational age at birth 37- 42 weeks;
- Normal birth weight for gestational age and gender i.e. 10th to 90th percentile compared to the WHO or local growth charts;
- Infants with regurgitation that are otherwise healthy, based upon the following criteria: 1) Regurgitation of 2 or more times per day for 1 or more weeks according to reported history, 2) an indication for the use of AR formula according to the investigator at screening/randomisation.
- Fully formula fed for at least 7 days before screening/randomisation;
- Written informed consent from the parent(s) and/or legally acceptable representative(s), aged ≥ 18 years.
- \-
Exclusion
- 1\. History of retching, hematemesis, aspiration, apnoea, failure to thrive, feeding or swallowing difficulties or abnormal posturing; 2. Gastrointestinal infection within 4 weeks prior to randomisation; 3. Congenital condition and/or previous or current illness and (or) medication use that could interfere with the main study outcomes according to the investigator; 4. Known cow's milk protein allergy, lactose intolerance, or galactosaemia including history of any other allergic manifestations or known allergy to any of the study product ingredients (especially scGOS); 5. Presence of any other gastrointestinal symptom(s)/disorder(s) that are not functional in nature, as assessed by the investigator's clinical judgement; 6. Received any of the following products/medication prior to randomisation: systemic antibiotics, prokinetics, proton pump inhibitors, complementary feeding/weaning within 4 weeks prior to randomisation; 7. 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; 8. Current participation in another clinical intervention study.
Key Trial Info
Start Date :
November 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2019
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT03371615
Start Date
November 4 2017
End Date
September 6 2019
Last Update
December 30 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Poliklinika Ginekologiczno-Poloznicza Sp. Z.O.O Sp.K
Bialystok, Poland, 15-435
2
Centrum Medyczne Promed
Krakow, Poland, 31411