This study is performed with healthy infants
Conditions
Interventions
After randomization, the subjects will consume the infant formulas during 2 periods of 4 weeks.
Infants will attend up to 4 visits :
- The selection visit (V0) is planned from birth to 2 months old.
Sponsors
FrieslandCampina
Eligibility
Inclusion criteria
Inclusion criteria: I1. Good general health with in the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination; I2. Age between birth and 2 months (limits included); I3. Full term infant (37 weeks ≤ gestational age ≤ 42 weeks); I4. 2500g ≤ birth weight ≤ 4500g; I5. Exclusively bottle-fed for at least one week at time of enrolment and only if parent(s) / guardian(s) independently decided before enrolment to exclusively bottle-feed; I6. Having obtained both parent’s or legally authorized representative’s written consent in accordance with legal requirements; I7. Parent(s) / guardian(s) who agree not to start complementary feeding during study period; I8. Two legal representatives (parent(s) / guardian(s)) who are capable of and willing to comply with the protocol; I9. At least one of the legal representatives is affiliated with a social security scheme.
Exclusion criteria
Exclusion criteria: E1. Significant pre-natal and/or serious post-natal disease (per investigator’s medical decision); E2. Subject under antibiotics treatment at time of enrolment or infant who was under antibiotics treatment until one week prior to V0; E3. With a known or suspected cow milk protein allergy (CMPA) or family medical history of CMPA; E4. With a known intolerance or hypersensitivity to any of the study products’ ingredients; E5. Exposure to probiotics (any product); E6. Minor parent(s) (below 18 years old); E7. Infants whose parent(s) / guardian(s) cannot be expected to comply with study procedures; E8. Currently participating or having participated in another clinical trial since birth; E9. Parent(s) / guardian(s) presenting a psychological or linguistic incapability to sign the informed consent; E10. Parent(s) / guardian(s) impossible to contact in case of emergency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 quant | — |
Contacts
Public ContactUrszula Kudla
FrieslandCampina Innovation Centre Mailing address: P.O. Box 238 6700 AE Wageningen
Outcome results
None listed