A Prebiotic Agave Derivated Metlin & Metlos in Infant Formula

December 1, 2010 updated by: National Institute of Pediatrics, Mexico

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico city, Mexico, 04530
        • National Pediatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks to 4 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: Exclusively 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
February 2010 to September 2010

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of Administration of Metlin & Metlos in Infant Formula
Time Frame: February 2010 to September 2010
Efficacy of Metlin & Metlos in Infant Formula was measured by means of the change on the intestinal micro flora; changes in the lipids profile (cholesterol, triglycerides, lipoproteins associated to cholesterol); changes in the anthropomorphic profile and somatic growth ( weight gain, stature, arm mean circumference, skin folds); bone mineral metabolism (bone ultrasonography); changes in the immunity (changes in the concentrations of salivary IgA) and reduction of respiratory events suggestive of infection.
February 2010 to September 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Pediatrics, Mexico

Collaborators

Nekutli S.A. de C.V.

Investigators

  • Study Director: Gabriel Lopez-Vealzquez, PhD, National Insitute of Pediatrics, Mexico
  • Principal Investigator: Pedro Gutierrez-Castrellon, MD, MSc, DSc, National Institute of Pediatrics, Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

December 1, 2010

First Submitted That Met QC Criteria

December 1, 2010

First Posted (Estimate)

December 2, 2010

Study Record Updates

Last Update Posted (Estimate)

December 2, 2010

Last Update Submitted That Met QC Criteria

December 1, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Metlin&MetlosChildren

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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