A Prebiotic Agave Derivated Metlin & Metlos in Infant Formula
关键词
抽象
日期
最后验证: | 11/30/2010 |
首次提交: | 11/30/2010 |
提交的预估入学人数: | 11/30/2010 |
首次发布: | 12/01/2010 |
上次提交的更新: | 11/30/2010 |
最近更新发布: | 12/01/2010 |
实际学习开始日期: | 01/31/2010 |
预计主要完成日期: | 04/30/2010 |
预计完成日期: | 09/30/2010 |
状况或疾病
干预/治疗
Dietary Supplement: Infant Formula
Dietary Supplement: Fully breast milk
Dietary Supplement: Metlin+Metlos+Lactobacillus GG
Dietary Supplement: Metlin+Lactobacillus GG
Dietary Supplement: Metlos+Lactobacillus GG
Dietary Supplement: Lactobacillus GG
相
手臂组
臂 | 干预/治疗 |
---|---|
Active Comparator: Infant Formula Infant Formula without lactobaillus or Metlin or Metlos | Dietary Supplement: Infant Formula Only Infant Formula without Lactobacillus, Metlin OR Metlos |
Active Comparator: Fully breast milk Group non randomized with fully breast milk | Dietary Supplement: Fully breast milk Children non randomized which mothers decided to feed them with exclusively breast milk |
Experimental: Metlin+Metlos+Lactobacillus GG Infant Formula added with Metlin+Metlos (6g/L) and Lactobacillus GG 0.3x107UFC | Dietary Supplement: Metlin+Metlos+Lactobacillus GG A prebiotic Agave Derivated Metlin+Metlos (6g/L) + 0.3x107 UFC Lactobacillus GG |
Active Comparator: Metlin+Lactobacillus GG Infant Formula added with Metlin (6g/L) + Lactobacillus GG 0.3x107 UFC | Dietary Supplement: Metlin+Lactobacillus GG A prebiotic Agave Derivated Metlin (6g/L) + 0.3x107 UFC Lactobacillus GG |
Active Comparator: Metlos+Lactobacillus GG Infant Formula added with Metlos (6g/L)+Lactobacillus GG 0.3x107UFC | Dietary Supplement: Metlos+Lactobacillus GG A prebiotic Agave Derivated Metlos (6g/L) + 0.3x107 UFC Lactobacillus GG |
Active Comparator: Lactobacillus GG Infant Formula added with Lactobacillus GG 0.3x107UFC without Metlin or Metlos | Dietary Supplement: Lactobacillus GG An Infant Formula added with 0.3x107 UFC Lactobacillus GG with no Metlin or Metlos |
资格标准
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - Healthy term babies (37 to 42 weeks of gestationl age) - Age 15 ± 7 days at admission - Birth weight > 2,490 g. - Negative history of formula intolerance (only randomized babies) - Signed Informed Consent Exclusion Criteria: - Clinical evidence of chronic cardiac, respiratory, gastrointestinal, hematological or metabolic disease. - Maternal medical history of diabetes (gestational diabetes was acceptable if the infant's birth weight was at or below the percentile 95; or 4153 g or 9 lbs 3 oz for girls or 4340 g or 9 lbs 9 oz for boys - Tuberculosis, immunologic deficiency, infection disease or perinatal infections known to cause adverse effects in the fetus - Participation in other study - Inability of the father/mother or legal tutor to reed or comprehend the informed consent and the symtoms report diary, or - The infant was part of multiple labor (twins, triplets, etc.) |
结果
主要结果指标
1. Safety of Metlin & Metlos Aministration in Infant Formula [February 2010 to September 2010]
次要成果指标
1. Efficacy of Administration of Metlin & Metlos in Infant Formula [February 2010 to September 2010]