Feeding Disorder
Conditions
Brief summary
Multinational, multicenter, clinical trial. To evaluate the effect of an experimental formula on GI symptoms and associated behaviors in unsettled infants with parent-reported feeding intolerance
Detailed description
The purpose of the present study is therefore to evaluate the effect of an experimental formula in an unsettled formula-fed infant population whose parents are considering switching formulas due to perceived feeding intolerance.
Interventions
OTHERExperimental Formula
Experimental formula
OTHERStandard control formula
Standard Infant formula
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Days to 90 Days
Healthy volunteers
Yes
Inclusion criteria
1. Full term infants, singleton, healthy at birth 2. Infants of parent(s)/LAR who have previously made the decision to exclusively formula feed their infant. 3. Infants exclusively consuming a standard formula for a minimum of 3 consecutive days prior to enrolment. 4. Infant's parent(s)/LAR are of legal age of consent and are willing and able to fulfil the requirements of the study protocol.
Exclusion criteria
1. Infants who are consuming any amount of supplemental human milk 2. Infants who are consuming weaning foods or beverages other than infant formula 3. Infants with known cow's milk allergy or family history of siblings with documented cow's milk protein intolerance/allergy 4. Infants who have a medical condition or history that could cause or contribute to feeding intolerance 5. Infants who received any other investigational intervention or who have participated in another clinical trial prior to enrolment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline to 14 days in fuss-cry behavior | from baseline to 14 days | fuss-cry behavior per 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to 14 days in GI symptoms | from baseline to 14 days |
Countries
Hong Kong, Philippines, Taiwan, Thailand
Outcome results
None listed