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Healthy Term BabiesPhase 3NCT01251783

A Prebiotic Agave Derivated Metlin & Metlos in Infant Formula

A Phase 3 study testing Infant Formula, Exclusively breast milk and Metlin+metlos+Lactobacillus GG in people with Healthy Term Babies, run by National Institute of Pediatrics, Mexico at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 +… Read more about this study

Who is it for?
Ages 15 to 30 daysHealthy volunteers can take part
Conditions the study is for
Healthy Term Babies
What is being tested?
Infant Formula, Exclusively breast milk and Metlin+metlos+Lactobacillus GG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteMexico
Study dates
Feb 2010to Oct 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 30 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.)

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • National Pediatric Institute

    Mexico City, Mexico City, 04530

Other trials in Mexico

About this study

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

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.

Being tested
Infant Formula, Exclusively breast milk, Metlin+metlos+Lactobacillus GG, Metlin + Lactobacillus GG, Metlos + lactobacillus GG
Keywords
term babies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Infant FormulaDietary supplement

    Only Infant Formula without Lactobacillus, Metlin OR Metlos

  • Exclusively breast milkDietary supplement

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

  • Metlin+metlos+Lactobacillus GGDietary supplement

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

  • Metlin + Lactobacillus GGDietary supplement

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

  • Metlos + lactobacillus GGDietary supplement

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

  • Lactobacillus GGDietary supplement

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

Study groups in NCT01251783
Study groupRoleWhat they receive
Infant FormulaActive comparatorInfant Formula without lactobaillus or Metlin or Metlos
Receives: Dietary Supplement: Infant Formula
Fully breast milkActive comparatorGroup non randomized with fully breast milk
Receives: Dietary Supplement: Exclusively breast milk
Metlin+Metlos+Lactobacillus GGExperimentalInfant Formula added with Metlin+Metlos (6g/L) and Lactobacillus GG 0.3x107UFC
Receives: Dietary Supplement: Metlin+metlos+Lactobacillus GG
Metlin+Lactobacillus GGActive comparatorInfant Formula added with Metlin (6g/L) + Lactobacillus GG 0.3x107 UFC
Receives: Dietary Supplement: Metlin + Lactobacillus GG
Metlos+Lactobacillus GGActive comparatorInfant Formula added with Metlos (6g/L)+Lactobacillus GG 0.3x107UFC
Receives: Dietary Supplement: Metlos + lactobacillus GG
Lactobacillus GGActive comparatorInfant Formula added with Lactobacillus GG 0.3x107UFC without Metlin or Metlos
Receives: Dietary Supplement: Lactobacillus GG

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: February 2010 to September 2010

Secondary outcomes (1)

  1. 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.

    Measured: February 2010 to September 2010

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2010 (estimated)
  2. Study startFeb 2010
  3. Primary completionMay 2010
  4. Study completionOct 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01251783
Sponsor's protocol ID
Metlin&MetlosChildren
Status last verified
Dec 2010
First submitted
1 Dec 2010
Last updated
2 Dec 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20416127

  • 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.

    PubMed 19941629

  • 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.

    PubMed 14690361

  • 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.

    PubMed 20832848

  • 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.

    PubMed 20730056

  • 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.

    PubMed 20119826

  • 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.

    PubMed 26529006

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Infant Formula, Exclusively breast milk and Metlin+metlos+Lactobacillus GG in people with Healthy Term Babies, run by National Institute of Pediatrics, Mexico at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of Metlin & Metlos Aministration in Infant Formula (time frame: February 2010 to September 2010). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01251783, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2010.

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