NCT01251783

A Prebiotic Agave Derivated Metlin & Metlos in Infant Formula

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: National Institute of Pediatrics, Mexico · Other Government
• Sex: All
• Age: 15 Days – 30 Days
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Term Babies

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Infant Formula	Only Infant Formula without Lactobacillus, Metlin OR Metlos
DIETARY_SUPPLEMENT	Exclusively breast milk	Children non randomized which mothers decided to feed them with exclusively breast milk
DIETARY_SUPPLEMENT	Metlin+metlos+Lactobacillus GG	A prebiotic Agave Derivated Metlin+Metlos (6g/L) + 0.3x107 UFC Lactobacillus GG
DIETARY_SUPPLEMENT	Metlin + Lactobacillus GG	A prebiotic Agave Derivated Metlin (6g/L) + 0.3x107 UFC Lactobacillus GG
DIETARY_SUPPLEMENT	Metlos + lactobacillus GG	A prebiotic Agave Derivated Metlos (6g/L) + 0.3x107 UFC Lactobacillus GG
DIETARY_SUPPLEMENT	Lactobacillus GG	An Infant Formula added with 0.3x107 UFC Lactobacillus GG with no Metlin or Metlos

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-05-01
• Completion: 2010-10-01
• First posted: 2010-12-02
• Last updated: 2010-12-02

Locations

1 site across 1 country: Mexico