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


- candidate number28982
- NTR NumberNTR7252
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-jun-2018
- Secondary IDsInternal protocol number  PEC17306
- Public TitleEffects of infant formula containing milk fat on the parameters of digestion
- Scientific TitleA DOUBLE-BLIND, RANDOMIZED, CONTROLLED, CROSS-OVER STUDY TO EVALUATE THE EFFECT OF A NEW FORMULA CONTAINING MILK FAT ON CALCIUM SOAP FORMATION, IN EXCLUSIVELY BOTTLE FED INFANTS.” OPTIMUS Study
- ACRONYMOptimus
- hypothesis4 weeks of consumption of an infant formula containing milk fat reduces calcium soap formation compared to the reference formula.
- Healt Condition(s) or Problem(s) studiedChildren, Milk, Digestion, Comfort, Milk fat, Calcium soap formation
- Inclusion criteriaI1. 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 criteriaE1. 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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- control[default]
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2018
- planned closingdate1-dec-2019
- Target number of participants22
- InterventionsAfter 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.
- The randomization visit (V1) is 1 week after V0. After randomization (stratified on age at inclusion), the infant will consume whether the tested product or the reference formula for 4 weeks.
- The infant will come back after 4 weeks after starting the formula (V2) and will start consuming the other formula for 4 weeks.
- The last visit is planned following the second period of 4 weeks consumption (V3).
Stools samples will be collected at V1, V2 and V3 visits.
- Primary outcomePrimary 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 outcomeSecondary 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.
- TimepointsInfants will attend up to 4 visits :
- The selection visit (V0) is planned from birth to 2 months old.
- The randomization visit (V1) is 1 week after V0. After randomization (stratified on age at inclusion), the infant will consume whether the tested product or the reference formula for 4 weeks.
- The infant will come back after 4 weeks after starting the formula (V2) and will start consuming the other formula for 4 weeks.
- The last visit is planned following the second period of 4 weeks consumption (V3).
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Urszula Kudla
- CONTACT for SCIENTIFIC QUERIES Anouk Feitsma
- Sponsor/Initiator Friesland Campina
- Funding
(Source(s) of Monetary or Material Support)
Friesland Campina
- Publications
- Brief summaryThe study will be carried out by Biofortis (CRO) and it will be located in Saint Herblain, France.
- Main changes (audit trail)
- RECORD7-jun-2018 - 10-jun-2018


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