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Completed

NCT Number: NCT01251783

A Prebiotic Agave Derivated Metlin & Metlos in Infant Formula

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.

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Key information

Conditions

Healthy Term Babies

Age range

15 day–30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Pediatric Institute

Mexico City, 04530, Mexico

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Infant Formula

Dietary Supplement

Only Infant Formula without Lactobacillus, Metlin OR Metlos

Exclusively breast milk

Dietary Supplement

Children non randomized which mothers decided to feed them with exclusively breast milk

Metlin+metlos+Lactobacillus GG

Dietary Supplement

A prebiotic Agave Derivated Metlin+Metlos (6g/L) + 0.3x107 UFC Lactobacillus GG

Metlin + Lactobacillus GG

Dietary Supplement

A prebiotic Agave Derivated Metlin (6g/L) + 0.3x107 UFC Lactobacillus GG

Metlos + lactobacillus GG

Dietary Supplement

A prebiotic Agave Derivated Metlos (6g/L) + 0.3x107 UFC Lactobacillus GG

Lactobacillus GG

Dietary Supplement

An Infant Formula added with 0.3x107 UFC Lactobacillus GG with no Metlin or Metlos

Primary outcomes

  1. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

National Institute of Pediatrics, Mexico

Other Gov

Collaborators

  • Nekutli S.A. de C.V.

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 2, 2010
Registry last updated
Dec 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.