A Prebiotic Agave Derivated Metlin & Metlos in Infant Formula

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

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

Sponsors & Collaborators

• Nekutli S.A. de C.V.

  collaborator UNKNOWN

• National Institute of Pediatrics, Mexico

  lead OTHER_GOV

Principal Investigators

• Gabriel Lopez-Vealzquez, PhD · National Insitute of Pediatrics, Mexico

• Pedro Gutierrez-Castrellon, MD, MSc, DSc · National Institute of Pediatrics, Mexico

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

15 Days

Max Age

30 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-02-28

Primary Completion

2010-05-31

Completion

2010-10-31

Countries

• Mexico

Study Locations