A Prebiotic Agave Derivated Metlin & Metlos in Infant Formula

National Institute of Pediatrics, Mexico

Status and phase: Completed; Phase 3

Conditions: Healthy Term Babies

Treatments: Dietary Supplement: Lactobacillus GG; Dietary Supplement: Metlin+metlos+Lactobacillus GG; Dietary Supplement: Infant Formula; Dietary Supplement: Exclusively breast milk; Dietary Supplement: Metlos + lactobacillus GG; Dietary Supplement: Metlin + Lactobacillus GG

Study type: Interventional

Funder types: Other

Identifiers

NCT01251783

Metlin&MetlosChildren

Details and patient eligibility

About

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.

Enrollment: 600 patients

Sex: All

Ages: 15 to 30 days old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

600 participants in 6 patient groups

Infant Formula

Active Comparator group

Description:

Infant Formula without lactobaillus or Metlin or Metlos

Treatment:

Dietary Supplement: Infant Formula

Fully breast milk

Active Comparator group

Description:

Group non randomized with fully breast milk

Treatment:

Dietary Supplement: Exclusively breast milk

Metlin+Metlos+Lactobacillus GG

Experimental group

Description:

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

Treatment:

Dietary Supplement: Metlin+metlos+Lactobacillus GG

Metlin+Lactobacillus GG

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Metlin + Lactobacillus GG

Metlos+Lactobacillus GG

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Metlos + lactobacillus GG

Lactobacillus GG

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Lactobacillus GG