Double Blind, Randomized, Controlled Clinical Trial for Evaluate The Efficiency and Safety of a Fiber System From Agave, With Prebiotic Action, Metlin® and Metlos®, Incorporated to an Infant Formula for Term Newborn Babies
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Healthy Term Babies
- Sponsor
- National Institute of Pediatrics, Mexico
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Safety of Metlin & Metlos Aministration in Infant Formula
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
Objectives: To evaluate the safety; efficacy; bone mineral metabolism & immunity changes of the use of Metlin & Metlos added to the Infant Formula Study Design: Randomized, double blind, clinical, controlled trial, in 600 full-term infants of 15 ± 7 days randomized to recive formula with probiotics + Metlin + Metlos; formula with probiotics + Metlin; Formula with probiotics + Metlos; formula only with probiotics or formula without probiotics and prebiotics; having a totally breast feed group as control.). Outcomes variables were frequency of stools; bowel intolerance manifestations (abdominal distension, flatulency, regurgitations, vomiting); report of dermatological problems like eczema; changes on the intestinal microbiota; lipids profile (cholesterol, triglycerides, lipoproteins associated to cholesterol); anthropomorphic profile and somatic growth ( weight gain, stature, arm mean circumference, skin folds); bone mineral metabolism (high-speed bone ultrasonography); and changes in the immunity (changes in the concentrations of salivary IgA and the frequency of respiratory events suggestive of infection)]. Statistical analysis was made with STATA Ver. 11.0 for Mac. Safety and efficacy variables, were compared by Chi squared in the case of categorical variables or by ANOVA or Kruskall Wallis for the numeric variables. When convenient, a covariates adjustment was done by ANOVA or by multiple lineal regressions for continuous numerical outcomes or logistic regression for categoric outcomes. In all the hypothesis tests the p significant value of <0.05 were used.
Investigators
Eligibility Criteria
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.)
Outcomes
Primary Outcomes
Safety of Metlin & Metlos Aministration in Infant Formula
Time Frame: February 2010 to September 2010
Safety of Metlin \& Metlos administration in infant formula was measured by means of the frequency of stools output reported daily by the mother or the keeper (nurse) during the whole study and by the presence gastrointestinal manifestations of intolerance (abdominal distension, flatulency, regurgitations, vomiting), or by the report of eczema type dermatological problems.
Secondary Outcomes
- Efficacy of Administration of Metlin & Metlos in Infant Formula(February 2010 to September 2010)