A Prebiotic Agave Derivated Metlin & Metlos in Infant Formula

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Term Babies

Intervention / Treatment
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* Dietary Supplement: Infant Formula
* Dietary Supplement: Exclusively breast milk
* Dietary Supplement: Metlin+metlos+Lactobacillus GG
* Dietary Supplement: Metlin + Lactobacillus GG
* Dietary Supplement: Metlos + lactobacillus GG
* Dietary Supplement: Lactobacillus GG


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 15 Days
Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Infant Formula<br>Infant Formula without lactobaillus or Metlin or Metlos | Dietary Supplement: Infant Formula<br>* Only Infant Formula without Lactobacillus, Metlin OR Metlos<br>|
| Active Comparator: Fully breast milk<br>Group non randomized with fully breast milk | Dietary Supplement: Exclusively breast milk<br>* Children non randomized which mothers decided to feed them with exclusively breast milk<br>|
| Experimental: Metlin+Metlos+Lactobacillus GG<br>Infant Formula added with Metlin+Metlos (6g/L) and Lactobacillus GG 0.3x107UFC | Dietary Supplement: Metlin+metlos+Lactobacillus GG<br>* A prebiotic Agave Derivated Metlin+Metlos (6g/L) + 0.3x107 UFC Lactobacillus GG<br>|
| Active Comparator: Metlin+Lactobacillus GG<br>Infant Formula added with Metlin (6g/L) + Lactobacillus GG 0.3x107 UFC | Dietary Supplement: Metlin + Lactobacillus GG<br>* A prebiotic Agave Derivated Metlin (6g/L) + 0.3x107 UFC Lactobacillus GG<br>|
| Active Comparator: Metlos+Lactobacillus GG<br>Infant Formula added with Metlos (6g/L)+Lactobacillus GG 0.3x107UFC | Dietary Supplement: Metlos + lactobacillus GG<br>* A prebiotic Agave Derivated Metlos (6g/L) + 0.3x107 UFC Lactobacillus GG<br>|
| Active Comparator: Lactobacillus GG<br>Infant Formula added with Lactobacillus GG 0.3x107UFC without Metlin or Metlos | Dietary Supplement: Lactobacillus GG<br>* An Infant Formula added with 0.3x107 UFC Lactobacillus GG with no Metlin or Metlos<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Metlin & Metlos Aministration in Infant Formula | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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term babies