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| Name | Class |
|---|---|
| Nekutli S.A. de C.V. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infant Formula | Active Comparator | Infant Formula without lactobaillus or Metlin or Metlos |
|
| Fully breast milk | Active Comparator | Group non randomized with fully breast milk |
|
| Metlin+Metlos+Lactobacillus GG | Experimental | Infant Formula added with Metlin+Metlos (6g/L) and Lactobacillus GG 0.3x107UFC |
|
| Metlin+Lactobacillus GG | Active Comparator | Infant Formula added with Metlin (6g/L) + Lactobacillus GG 0.3x107 UFC |
|
| Metlos+Lactobacillus GG | Active Comparator | Infant Formula added with Metlos (6g/L)+Lactobacillus GG 0.3x107UFC |
|
| Lactobacillus GG | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infant Formula | Dietary Supplement | Only Infant Formula without Lactobacillus, Metlin OR Metlos |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriel Lopez-Vealzquez, PhD | National Insitute of Pediatrics, Mexico | Study Director |
| Pedro Gutierrez-Castrellon, MD, MSc, DSc | National Institute of Pediatrics, Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Pediatric Institute | Mexico City | Mexico City | 04530 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20416127 | Background | 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. | |
| 19941629 | Background | 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. |
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| ID | Term |
|---|---|
| D041943 | Infant Formula |
| ID | Term |
|---|---|
| D041941 | Milk Substitutes |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Infant Formula added with Lactobacillus GG 0.3x107UFC without Metlin or Metlos |
|
| Exclusively breast milk | Dietary Supplement | Children non randomized which mothers decided to feed them with exclusively breast milk |
|
| Metlin+metlos+Lactobacillus GG | Dietary Supplement | A prebiotic Agave Derivated Metlin+Metlos (6g/L) + 0.3x107 UFC Lactobacillus GG |
|
| Metlin + Lactobacillus GG | Dietary Supplement | A prebiotic Agave Derivated Metlin (6g/L) + 0.3x107 UFC Lactobacillus GG |
|
| Metlos + lactobacillus GG | Dietary Supplement | A prebiotic Agave Derivated Metlos (6g/L) + 0.3x107 UFC Lactobacillus GG |
|
| Lactobacillus GG | Dietary Supplement | An Infant Formula added with 0.3x107 UFC Lactobacillus GG with no Metlin or Metlos |
|
| February 2010 to September 2010 |
| 14690361 | Background | 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. |
| 20832848 | Background | 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. |
| 20730056 | Background | 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. |
| 20119826 | Result | 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. |
| 26529006 | Derived | 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. |
| D005526 |
| Food, Formulated |
| D019648 | Foods, Specialized |
| D005502 | Food |
| D007225 | Infant Food |
| D019602 | Food and Beverages |