Microbiota composition in healthy termed infants consuming infant formulae with different fat blends.

FrieslandCampina N.V.0 个研究点目标入组 14 人开始时间: 待定最近更新: 2024年2月28日

试验速览

暂无简介。

•Full-term, healthy infants (born at gestational age =37 weeks).
•- Appropriate for gestational age birthweight (i.e. 10th centile = Birth weight = 90th centile).
•- Age at enrolment: between 9th-14th 16th week
•- Exclusively formula fed infants at least two weeks before recruitment and during the entire intervention period.
•- Parents willing and agreeing to initiate complementary feeding after the end of endpoint measurements, i.e. after the completion of the 5.5th month of age
•- Parents willing to collect stools and fill in all study questionnaires and diaries during the entire intervention period
•- Written informed consent

•- Severe acquired or congenital diseases, mental or physical disorders, any symptoms of allergy (including cow¡¯s milk allergy).
•- No parents or siblings with documented CMA allergy, diagnosed by a doctor.
•- Use of probiotics, antibiotics or other medication that treats or causes GI symptoms and/or affect appetite at the time of screening or at any time throughout the study period (these infants will be considered as drop-outs).
•- Use of medication(s) known or suspected to affect fat digestion, absorption and/or metabolism; nutritional supplements; suppositories; medication that may suppress or neutralize gastric acid secretion and gut mobility at the time of screening or at any time throughout the study period (these infants will be considered as drop-outs).
•- Participation in another clinical trial.
•- Any type of mixed feeding (i.e. combination of formula with breastfeeding in any proportion) and/or complementary feeding during the intervention.

发起方

FrieslandCampina N.V.