A Prebiotic Agave Derivated Metlin & Metlos in Infant Formula

Phase 3

Completed

• Conditions: Healthy Term Babies
• Interventions: 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

• Registration Number: NCT01251783
• Lead Sponsor: National Institute of Pediatrics, Mexico

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2010-05
• Study Completion: 2010-10
• Status Verified: 2010-12
• Study First Submitted: 2010-12-01
• Study First Submitted QC: 2010-12-01
• Last Update Submitted: 2010-12-01
• Study First Posted: 2010-12-02
• Last Update Posted: 2010-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infant Formula	Infant Formula	Infant Formula without lactobaillus or Metlin or Metlos
Fully breast milk	Exclusively breast milk	Group non randomized with fully breast milk
Metlin+Metlos+Lactobacillus GG	Metlin+metlos+Lactobacillus GG	Infant Formula added with Metlin+Metlos (6g/L) and Lactobacillus GG 0.3x107UFC
Metlin+Lactobacillus GG	Metlin + Lactobacillus GG	Infant Formula added with Metlin (6g/L) + Lactobacillus GG 0.3x107 UFC
Metlos+Lactobacillus GG	Metlos + lactobacillus GG	Infant Formula added with Metlos (6g/L)+Lactobacillus GG 0.3x107UFC
Lactobacillus GG	Lactobacillus GG	Infant Formula added with Lactobacillus GG 0.3x107UFC without Metlin or Metlos

Primary Outcome Measures

Name	Time	Method
Safety of Metlin & Metlos Aministration in Infant Formula	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 Outcome Measures

Name	Time	Method
Efficacy of Administration of Metlin & Metlos in Infant Formula	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.

Trial Locations

Locations (1)

National Pediatric Institute; 🇲🇽 Mexico city, Mexico