NL-OMON20358尚未招募不适用
Toddlers receiving synbiotics after antibiotics
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 156
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Study participants (n=126):
- •1.Written informed consent obtained from both caregivers;
- •2.Caregivers are willing to comply with the requirements of the study;
- •3.Age 1-2 year old at the time of enrollment;
- •4.Drinks cow’s milk (non-fat, semi-skimmed or full fat) on a daily basis;
- •5.Received a prescription for amoxicillin.
- •Age-matched control group (n=30):
- •1.Written informed consent obtained from both caregivers;
- •2.Caregivers are willing to comply with the requirements of the study;
- •3.Age 1 year old;
排除标准
- •Study participants (n=126):
- •1.Any GI complaints, known structural GI abnormalities, or previous GI surgery;
- •2.Clinically significant cardiac, vascular, liver, pulmonary, psychiatric disorders, severe renal insufficiency, human immunodeficiency virus infection, acquired immunodeficiency syndrome, hepatitis B or C or abnormalities of haematology, urinalysis, or blood biochemistry;
- •3.Known to have an allergy or intolerance to any of the ingredients in the study- or control product, including lactose and cow’s milk protein;
- •4.Used pre-or probiotic supplements or food products with added pre- or probiotics (e.g. formula containing GOS or FOS, Activia, Actimel, Yakult, etc.) in the last 7 days before start of the antibiotic treatment;
- •5.Is receiving breastmilk, or has received breastmilk in the last 7 days before start of antibiotic treatment.
- •Age-matched control group (n=30):
- •1.Any GI complaints, known structural GI abnormalities, or previous GI surgery;
- •2.Clinically significant cardiac, vascular, liver, pulmonary, psychiatric disorders, severe renal insufficiency, human immunodeficiency virus infection, acquired immunodeficiency syndrome, hepatitis B or C or abnormalities of haematology, urinalysis, or blood biochemistry;
- •3.Known to have an allergy or intolerance to any of the ingredients in the study- or control product, including lactose and cow’s milk protein;
- •4.Used pre-or probiotic supplements or food products with added pre- or probiotics (e.g. formula containing GOS or FOS, Activia, Actimel, Yakult, etc.) in the last 7 days before start of the antibiotic treatment;
- •5.Has received any broad-spectrum antibiotic treatment at any time in his/her life.
研究者
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