Comparative study of infant formulas in the Mexican population

FrieslandCampina0 个研究点目标入组 342 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•(i) Term infants (gestational age > 37 weeks and < 42 weeks). (ii) Between 1- 4 months of age without weaning food intake. (iii) Birth weight of 2.5 – 4kg. (iv) Exclusively formula fed. (v) Feeding on the current formula at least 3 weeks prior to the study week. (vi) Infant cared for at home by one or two primary caregivers (parents, legal guardians, etc) who can oversee and record all activity related to data collection. (vii) Parents/caregivers agree to offer (or have offered) no additional food (other than water) over the course of the study and 48 hours before initiation of data collection. (viii) Consenting parent/legal guardian > 18 years old. (ix) Reporting parent fluent in Spanish (language of study). (x) Parents/caregivers own a smartphone and have 24-hour internet connection availability. (xi) At least one of the caregivers should be able to check their email accounts using their smartphone, and successfully download the ClaimIt app during the Screening visit.

•(i) Breastfed within 3 weeks prior to start of study. (ii) Switched formula within 3 weeks prior to start of the study. (iii) Any complimentary feeding. (iv) Weight-for-length (WFL) above 85th or under 5th percentiles at birth. (v) Congenital condition and/or previous or current illness that, according to the medical judgement of the PI, could interfere with study. These include, but are not limited to; GI tract or metabolic diseases that affect the digestion process and/or confort of the subjects. (vi) Known or increased risk of cow’s milk allergy and/ or lactose intolerance (i.e. one of the biological parents and or siblings diagnosed with cow’s milk allergy, asthma, fever, etc.). (vii) Current participation in another survey or clinical trial. (viii) Investigator's uncertainty about the willingness or ability of the /caregivers to comply with the protocol requirements (eg. Internet availability, use of technology, compliance with study visits, filling in of diaries and waiting until finishing the study to introduce weaning foods, etc). (ix) Use of antibiotics and/or medication that, based on the investigator´s judgement, treats/cause GI symptoms and appetite changes, as well as probiotic and/or prebiotic supplements (other than those found in the formula itself) at the time of screening and/or two weeks prior to the start of the study.

发起方

FrieslandCampina