Effects of infant formula containing milk fat on the parameters of digestion

Primary endpoint

The primary endpoint in this study is the total fatty acid-calcium soap excretion, at the end of each 4 weeks period of consumption, measured as mg fatty acid-calcium soaps/kg of dry weight (dw) fecal matter

Secondary endpoints

The secondary endpoints in this research are listed below :

1. % of individual fatty acids of the fat from the extracted calcium soaps, at the end of each 4 weeks period of consumption (relevant fatty acids are the sum of C4:0-C12:0, C14:0, C16:0, C16:1, C18:0, C18:1, C18:2, C18:3, C20:3, C20:4, C20:5 and C22:6);

2. % of individual fatty acids from the extracted fecal fat, at the end of each 4 weeks period of consumption (total fatty acids corresponds to the sum of C4:0-C12:0, C14:0, C16:0, C16:1, C18:0, C18:1, C18:2, C18:3, C20:3, C20:4, C20:5 and C22:6);

3. Fecal fat excretion in mg/kg dw fecal matter, at the end of period 1 and at the end of period 2;

4. Calcium excretion in mg/kg dw fecal matter, at the end of period 1 and at the end of period 2;

5. Stool consistency, amount and color: assessed by individual proportion of stools in each type using the “Amsterdam Infant Stool Scale (AISS)” questionnaire during the 3 prior days of period 1 and period 2;

6. Gut comfort: IGSQ 13©-item total score (Infant Gastrointestinal Symptom Questionnaire) at visits V2 and V3 and the daily crying diary during 3 consecutive days at the end of period 1 and period 2.

Safety endpoints

The safety endpoints, are listed below :

1. Anthropometric measurement at V0, V1, V2 and V3, compared to WHO standards :

a. height-for-age z-score,

b. weight-for-age z-score,

c. weight-for-height z-score,

d. head circumference-for-age z-score,

e. and body mass index-for-age z-score.

2. Morbidity assessed from Informed Consent Form (ICF) signing until the end of the study:

a. Incidence of adverse events (AEs), including type, severity, seriousness and relation to study formulas, from date of ICF signing through the end of the study or until resolved

b. Incidence of Serious AEs (SAEs) from date of informed consent through the end of the study or until resolved

3. Energy and nutrient intake assessed by the quantity of milk (mL) consumed (difference between quantity of milk (mL) consumed and quantity of milk not consumed or vomited (mL)) using a feeding questionnaire completed by parent(s) / guardian(s) at V2 and V3.

The volume vomited will be expressed in teaspoon volumes (5 mL), tablespoon volumes (15 mL), 30 mL, half of feeding bottle or more than a half of feeding bottle.