NCT01251783

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2010

Completed
Last Updated

December 2, 2010

Status Verified

December 1, 2010

Enrollment Period

3 months

First QC Date

December 1, 2010

Last Update Submit

December 1, 2010

Conditions

Healthy Term Babies

Keywords

term babies

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Efficacy of Administration of Metlin & Metlos in Infant Formula

    February 2010 to September 2010

Study Arms (6)

Infant Formula

ACTIVE COMPARATOR

Infant Formula without lactobaillus or Metlin or Metlos

Dietary Supplement: Infant Formula

Fully breast milk

ACTIVE COMPARATOR

Group non randomized with fully breast milk

Dietary Supplement: Exclusively breast milk

Metlin+Metlos+Lactobacillus GG

EXPERIMENTAL

Infant Formula added with Metlin+Metlos (6g/L) and Lactobacillus GG 0.3x107UFC

Dietary Supplement: Metlin+metlos+Lactobacillus GG

Metlin+Lactobacillus GG

ACTIVE COMPARATOR

Infant Formula added with Metlin (6g/L) + Lactobacillus GG 0.3x107 UFC

Dietary Supplement: Metlin + Lactobacillus GG

Metlos+Lactobacillus GG

ACTIVE COMPARATOR

Infant Formula added with Metlos (6g/L)+Lactobacillus GG 0.3x107UFC

Dietary Supplement: Metlos + lactobacillus GG

Lactobacillus GG

ACTIVE COMPARATOR

Infant Formula added with Lactobacillus GG 0.3x107UFC without Metlin or Metlos

Dietary Supplement: Lactobacillus GG

Interventions

Infant FormulaDIETARY_SUPPLEMENT

Only Infant Formula without Lactobacillus, Metlin OR Metlos

Infant Formula
Exclusively breast milkDIETARY_SUPPLEMENT

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

Fully breast milk
Metlin+metlos+Lactobacillus GGDIETARY_SUPPLEMENT

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

Metlin+Metlos+Lactobacillus GG
Metlin + Lactobacillus GGDIETARY_SUPPLEMENT

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

Metlin+Lactobacillus GG
Metlos + lactobacillus GGDIETARY_SUPPLEMENT

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

Metlos+Lactobacillus GG
Lactobacillus GGDIETARY_SUPPLEMENT

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

Lactobacillus GG

Eligibility Criteria

Age15 Days - 30 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Pediatric Institute

Mexico City, Mexico City, 04530, Mexico

Location

Related Publications (7)

  • Leach JD, Sobolik KD. High dietary intake of prebiotic inulin-type fructans in the prehistoric Chihuahuan Desert. Br J Nutr. 2010 Jun;103(11):1558-61. doi: 10.1017/S0007114510000966. Epub 2010 Apr 26.

    PMID: 20416127BACKGROUND

  • Gomez E, Tuohy KM, Gibson GR, Klinder A, Costabile A. In vitro evaluation of the fermentation properties and potential prebiotic activity of Agave fructans. J Appl Microbiol. 2010 Jun;108(6):2114-21. doi: 10.1111/j.1365-2672.2009.04617.x. Epub 2009 Nov 4.

    PMID: 19941629BACKGROUND

  • Lopez MG, Mancilla-Margalli NA, Mendoza-Diaz G. Molecular structures of fructans from Agave tequilana Weber var. azul. J Agric Food Chem. 2003 Dec 31;51(27):7835-40. doi: 10.1021/jf030383v.

    PMID: 14690361BACKGROUND

  • Gruber C, van Stuijvenberg M, Mosca F, Moro G, Chirico G, Braegger CP, Riedler J, Boehm G, Wahn U; MIPS 1 Working Group. Reduced occurrence of early atopic dermatitis because of immunoactive prebiotics among low-atopy-risk infants. J Allergy Clin Immunol. 2010 Oct;126(4):791-7. doi: 10.1016/j.jaci.2010.07.022. Epub 2010 Sep 15.

    PMID: 20832848BACKGROUND

  • Sazawal S, Dhingra U, Hiremath G, Sarkar A, Dhingra P, Dutta A, Verma P, Menon VP, Black RE. Prebiotic and probiotic fortified milk in prevention of morbidities among children: community-based, randomized, double-blind, controlled trial. PLoS One. 2010 Aug 13;5(8):e12164. doi: 10.1371/journal.pone.0012164.

    PMID: 20730056BACKGROUND

  • Sabater-Molina M, Larque E, Torrella F, Zamora S. Dietary fructooligosaccharides and potential benefits on health. J Physiol Biochem. 2009 Sep;65(3):315-28. doi: 10.1007/BF03180584.

    PMID: 20119826RESULT

  • Lopez-Velazquez G, Parra-Ortiz M, Mora Ide L, Garcia-Torres I, Enriquez-Flores S, Alcantara-Ortigoza MA, Angel AG, Velazquez-Aragon J, Ortiz-Hernandez R, Cruz-Rubio JM, Villa-Barragan P, Jimenez-Gutierrez C, Gutierrez-Castrellon P. Effects of Fructans from Mexican Agave in Newborns Fed with Infant Formula: A Randomized Controlled Trial. Nutrients. 2015 Oct 29;7(11):8939-51. doi: 10.3390/nu7115442.

    PMID: 26529006DERIVED

MeSH Terms

Interventions

Infant Formula

Intervention Hierarchy (Ancestors)

Milk SubstitutesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood, FormulatedFoods, SpecializedFoodInfant FoodFood and Beverages

Study Officials

  • Gabriel Lopez-Vealzquez, PhD

    National Insitute of Pediatrics, Mexico

    STUDY DIRECTOR

  • Pedro Gutierrez-Castrellon, MD, MSc, DSc

    National Institute of Pediatrics, Mexico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 1, 2010

First Posted

December 2, 2010

Study Start

February 1, 2010

Primary Completion

May 1, 2010

Study Completion

October 1, 2010

Last Updated

December 2, 2010

Record last verified: 2010-12

Locations

ME(1)