4 weeks of consumption of an infant formula containing milk fat reduces calcium soap formation compared to the reference formula.
ID
Bron
Verkorte titel
Aandoening
This study is performed with healthy infants;
infant formula; digestion, comfort, calcium soap formation, milk fat;
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary endpoint<br>
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
Achtergrond van het onderzoek
The study will be carried out by Biofortis (CRO) and it will be located in Saint Herblain, France.
Doel van het onderzoek
4 weeks of consumption of an infant formula containing milk fat reduces calcium soap formation compared to the reference formula.
Onderzoeksopzet
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).
Onderzoeksproduct en/of interventie
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.
- 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.
Publiek
Mailing address: P.O. Box 238 6700 AE Wageningen
Urszula Kudla
Bronland 20
Wageningen 6708 WH
The Netherlands
+31 (0)6469 11 337
urszula.kudla@frieslandcampina.com
Wetenschappelijk
Mailing address: P.O. Box 238 6700 AE Wageningen
Urszula Kudla
Bronland 20
Wageningen 6708 WH
The Netherlands
+31 (0)6469 11 337
urszula.kudla@frieslandcampina.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL7047 |
NTR-old | NTR7252 |
Ander register | PEC17306 : Internal protocol number |