Gastrointestinal Tolerance, Safety And Acceptability In Infants Consuming Palm Oil Free Infant Formula Containing Prebiotics And Postbiotics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety - Adverse Events
研究概览
简要总结
This prospective, single-arm study evaluates the gastrointestinal tolerance, safety, and growth, quality of life and gut microbiome development of healthy term infants fed a commercially available palm oil free infant formula containing prebiotics and postbiotics derived from fermentation over a 24-week period. Infants aged 0 to 6 weeks who were exclusively formula-fed at enrolment received the study formula as their sole source of nutrition. The primary objective is to assess gastrointestinal tolerance and safety. Secondary objectives include assessment of infant quality of life, parental experience and to characterise the development of the infant gut microbiome. The study includes four visits over 24 weeks, during which clinical measurements, safety assessments, and sample collection are performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- — 至 6 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent's or legal guardian's aged 18 years, written informed consent.
- •Infants exclusively formula fed at enrolment and parents/legal guardians have autonomously decided to exclusively formula feed until the end of intervention.
- •Infants aged 0 to 6 weeks (day 0 to day 42 inclusive).
- •Healthy term singleton infants, gestational age ~ 37 and < 42 weeks (i.e.,~ 41 weeks+ 6 days). Healthy is defined as no supervision or medical treatment by a medical specialist.
- •Birth weight between 2.5 - 4.5 kg (within normal range for gestational age and sex, according to WHO definitions).
- •Willing to continue using the infant formula, during the study, not switching of formula, except for medical purposes in which case the infant would be excluded.
排除标准
- •Infants with congenital condition and/or previous or current illness and (or) medication use that could interfere with the study, in the opinion of the medical doctor.
- •Infants with established or suspected cows' milk allergy, lactose intolerance, galactosaemia, or infants on a prescribed fibre-free (e.g., prebiotic oligosaccharides) diet.
- •Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
- •Investigator's uncertainty about the willingness or ability of the parents/legal guardians to comply with the protocol requirements.
研究组 & 干预措施
Infant formula
24-weeks consumption of cow's milk based palm oil free infant formula with prebiotics and postbiotics derived from fermentation
干预措施: Infant Formula (Other)
结局指标
主要结局
Safety - Adverse Events
时间窗: 24 weeks
Occurrence of (serious) AE measured throughout the intervention period.
Safety - Growth (Head circumference)
时间窗: 24 weeks
Safety parameters included head circumference measured at baseline, week 2, week 10, and week 24 of intervention.
Gastrointestinal Tolerance - Stool consistency and frequency
时间窗: 24 weeks
Gastrointestinal tolerance evaluated with stool consistency and stool frequency for 3 consecutive days after first intake of study product and before each visit at week 2, week 10, and week 24 of intervention.
Gastrointestinal Tolerance - PedsQL
时间窗: 24 weeks
PedsQL to assess infant's quality of life at baseline and week 2, week 10, and week 24.
Gastrointestinal Tolerance - IGSQ-13
时间窗: 24 weeks
IGSQ-13 questionnaire to asses gastrointestinal tolerance at baseline and week 2, week 10, and week 24.
Safety - Growth (Weight)
时间窗: 24 weeks
Safety parameters included weight gain measured at baseline, week 2, week 10, and week 24 of intervention.
Safety - Growth (Length)
时间窗: 24 weeks
Safety parameters included length gain measured at baseline, week 2, week 10, and week 24 of intervention.
Gastrointestinal Tolerance - Pediatric Quality of Life Inventory (PedsQL)
时间窗: 24 weeks
Scores are transformed to a 0 to 100 scale, with higher scores indicating better health-related quality of life and fewer problems. PedsQL to assess infant's quality of life at baseline and week 2, week 10, and week 24.
Gastrointestinal Tolerance - Infant Gastrointestinal Symptom Questionnaire (IGSQ-13)
时间窗: 24 weeks
The IGSQ-13 consists of 13 items with a total score ranging from 13 to 65, where lower scores indicate better gastrointestinal tolerance and fewer symptoms, and higher scores indicate greater gastrointestinal distress. IGSQ-13 questionnaire to asses gastrointestinal tolerance at baseline and week 2, week 10, and week 24.
次要结局
未报告次要终点