A Prebiotic Agave Derivated Metlin & Metlos in Infant Formula
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ClinicalTrials.gov Identifier: NCT01251783 |
Recruitment Status
:
Completed
First Posted
: December 2, 2010
Last Update Posted
: December 2, 2010
|
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Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
Actual Enrollment : | 600 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | May 2010 |
Actual Study Completion Date : | October 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Infant Formula
Infant Formula without lactobaillus or Metlin or Metlos
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Dietary Supplement: Infant Formula
Only Infant Formula without Lactobacillus, Metlin OR Metlos
|
Active Comparator: Fully breast milk
Group non randomized with fully breast milk
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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
|
- Safety of Metlin & Metlos Aministration in Infant Formula [ Time Frame: 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.
- Efficacy of Administration of Metlin & Metlos in Infant Formula [ Time Frame: 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.

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Ages Eligible for Study: | up to 30 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01251783
Mexico | |
National Pediatric Institute | |
Mexico city, Mexico, 04530 |
Study Director: | Gabriel Lopez-Vealzquez, PhD | National Insitute of Pediatrics, Mexico | |
Principal Investigator: | Pedro Gutierrez-Castrellon, MD, MSc, DSc | National Institute of Pediatrics, Mexico |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pedro Gutierrez Castrellon, National Pediatric of Pediatrics, Mexico |
ClinicalTrials.gov Identifier: | NCT01251783 History of Changes |
Other Study ID Numbers: |
Metlin&MetlosChildren |
First Posted: | December 2, 2010 Key Record Dates |
Last Update Posted: | December 2, 2010 |
Last Verified: | December 2010 |
Keywords provided by National Institute of Pediatrics, Mexico:
term babies |