NCT04745455已完成不适用
An Open-label Single-arm Study to Investigate Gastrointestinal Tolerance, Safety, and Acceptability of a New Infant Formula Containing Prebiotics, Probiotics and Postbiotics, in Healthy Term Infants.
Nutricia Research6 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2021年1月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 6
- 主要终点
- Gastrointestinal tolerance
研究概览
简要总结
A study to investigate the gastrointestinal tolerance and safety of a new formula containing prebiotics, probiotics and postbiotics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 14 Days 至 84 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Term infants with a gestational age at birth of ≥37 weeks + 0 days and ≤41 weeks + 6 days;
- •Singleton, healthy infants as judged by the principle investigator;
- •Infants with age at screening ≥2 weeks (14 days) and ≤ 12 weeks (84 days)
- •Infants who are fully formula fed for at least 1 week prior to screening and whose parents have autonomously decided to fully formula feed, i.e. not to breastfeed or have ended breastfeeding, and who are intending to fully formula feed;
- •Written informed consent from the parent(s) and/or legally acceptable representative(s), aged ≥ 18 years.
排除标准
- •Infants who require to be fed a special diet other than standard cow's milk-based infant formula;
- •Infants known to have or suspected to have cow's milk protein allergy, lactose intolerance, or galactosaemia including history of any other allergic manifestations or known allergy to any of the study product ingredients;
- •Infants with known or suspected congenital diseases or malformations which could interfere with the study or its outcome parameters, such as but not limited to: GI malformations, congenital metabolic disorders, severe congenital cardiac disorders, immunodeficiency or major surgery, as per the clinical judgment of the Investigator;
- •Infants diagnosed with a gastrointestinal infection within 4 weeks prior to screening;
- •Infants with current or previous illnesses/conditions or interventions which could interfere with the study or its outcome parameters (e.g. diarrhea requiring treatment, constipation requiring treatment, regurgitation requiring treatment, dental/medical procedures which may impact oral feeding), as per the clinical judgment of the Investigator;
- •Received any of the following products/medication prior to screening: systemic antibiotics, prokinetics, proton pump inhibitors, prebiotic supplements, probiotic supplements, complementary feeding/weaning within 4 weeks prior to screening;
- •Incapability of infants' parents to comply with study protocol as per the judgment of the Investigator (e.g. fluency in local language, access to laptop/smartphone devices and internet connection required for data collection);
- •Infants with previous, current or intended participation in any other clinical study involving investigational or marketed products concomitantly or prior to study.
结局指标
主要结局
Gastrointestinal tolerance
时间窗: Day 28
A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.
次要结局
- Stool frequency(Day 28)
- Stool consistency(Day 28)
- Incidence, frequency, and severity of (S)AEs, and relatedness to study product of (Serious) Adverse Events.(Through study completion, an average of one month)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
不适用
Gastrointestinal Tolerance Study of a New Infant FormulaHealthy InfantsNCT01681355Danone Asia Pacific Holdings Pte, Ltd.50
已完成
不适用
Pilot Study on Gastro-intestinal (GI) Enteral Nutrition (EN) Tolerance in Intensive Care Unit PatientsCritically IllNCT01581957Société des Produits Nestlé (SPN)90
已完成
1 期
A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions.Primary Ovarian InsufficiencyMetrorrhagiaVaginitisMenopauseNCT01436513Pfizer72
已完成
1 期
Impact of Butyricicoccus Pullicaecorum in Healthy SubjectsHealthyNCT02477033KU Leuven30
已完成
2 期
Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's DiseaseCrohn DiseaseNCT03476317Children's Hospital of Philadelphia10