A Prebiotic Agave Derivated Metlin & Metlos in Infant Formula

This study has been completed.
Sponsor:
Collaborator:
Nekutli S.A. de C.V.
Information provided by:
National Institute of Pediatrics, Mexico
ClinicalTrials.gov Identifier:
NCT01251783
First received: December 1, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Healthy Term Babies
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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by National Institute of Pediatrics, Mexico:

Primary Outcome Measures:
  • Safety of Metlin & Metlos Aministration in Infant Formula [ Time Frame: February 2010 to September 2010 ] [ Designated as safety issue: Yes ]
    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:
  • Efficacy of Administration of Metlin & Metlos in Infant Formula [ Time Frame: February 2010 to September 2010 ] [ Designated as safety issue: No ]
    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.


Enrollment: 600
Study Start Date: February 2010
Study Completion Date: October 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01251783

Locations
Mexico
National Pediatric Institute
Mexico city, Mexico, 04530
Sponsors and Collaborators
National Institute of Pediatrics, Mexico
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
  More Information

Publications:
Responsible Party: Pedro Gutierrez Castrellon, National Pediatric of Pediatrics, Mexico
ClinicalTrials.gov Identifier: NCT01251783     History of Changes
Other Study ID Numbers: Metlin&MetlosChildren
Study First Received: December 1, 2010
Last Updated: December 1, 2010
Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by National Institute of Pediatrics, Mexico:
term babies

ClinicalTrials.gov processed this record on August 28, 2014