Regurgitation, Gastric
Conditions
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 regurgitation.
Interventions
OTHERAnti-regurgitation infant formula
Anti regurgitation infant formula
Sponsors
Nutricia Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Weeks to 13 Weeks
Healthy volunteers
Yes
Inclusion criteria
1. Singleton healthy term infant aged 3 - 13 weeks; 2. Gestational age at birth 37- 42 weeks; 3. Normal birth weight for gestational age and gender i.e. 10th to 90th percentile compared to the WHO or local growth charts; 4. 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. 5. Fully formula fed for at least 7 days before screening/randomisation; 6. Written informed consent from the parent(s) and/or legally acceptable representative(s), aged ≥ 18 years. \-
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GI tolerance | 4 weeks | To assess the gastrointestinal (GI) tolerance of the investigational product compared to the control product based on Infant Gastrointestinal Symptom Questionnaire(IGSQ) symptoms score containg 13 questions on a 7 point scale |
Countries
Poland
Outcome results
None listed