Functional Evaluation of Two Infant Formula Supplemented With Probiotics Isolated From Breast Milk

Study Overview
=================
Brief Summary
-----------------
A randomized double blinded controlled study including infants at the age of 1 month . Infants are assigned randomly to either infant formula supplemented with B. breve CECT7263 or L.fermentum CECT5716 (Probiotic groups), or the same formula without the probiotic strain (Control group). The primary outcome of the study is the body weight gain of infants. Secondary outcomes are incidence of infections, symptoms related with intestinal function, and fecal microbiota

Official Title
-----------------
Functional Evaluation of Two Infant Formula Supplemented With Probiotics Isolated From Breast Milk

Conditions
-----------------
Infant Nutrition

Intervention / Treatment
-----------------
* Dietary Supplement: Lfer
* Dietary Supplement: Bifido
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborn infants at term (37-42 weeks gestational age) healthy during the first month of life, for reasons unrelated to the study, abandon breastfeeding during the first month of life. Signature of informed parental or guardian consent. Exclusion Criteria: Allergic to the protein in cow's milk. Lactose intolerant. Suffering from a serious metabolic disease. They have experienced or are experiencing some severe gastrointestinal disease. Receive some form of chronic medication or are receiving antibiotics at the time of capture. Low expectation of compliance with the study protocol. allergic to any group of antibiotics.

Ages Eligible for Study
-----------------
Minimum Age: 3 Weeks
Maximum Age: 5 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bifido<br>Infant formula containing Bifidobacterium breve CECT7263 | Dietary Supplement: Bifido<br>* Probiotic bacteria originally isolated from breast milk: the strain Bifidobacterium breve CECT7263<br>|
| Active Comparator: Lfer<br>Infant formula containing Lactobacillus fermentum CECT5716 | Dietary Supplement: Lfer<br>* Probiotic bacteria originally isolated from breast milk: the strain Lactobacillus fermentum CECT5716<br>|
| Placebo Comparator: Control<br>Standard infant formula | Other: Control<br>* Standard infant formula<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight gain | Body weight gain at 12 months (grams) | 12 months versus baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length | Length (cm) | 1,2,4,6,9 and 12 months of age | 
| Body weight | Body weight of infants at different times (kg) | 1,2,4,6,9 and 12 months of age | 
| Incidence of infections | Events of infections diseases during intervention period (Incidence rate) | total incidence during intervention (11 months) | 
| Bacterial load in feces | Counts of Lactobacillus, bifidobacteria, bacteroides, clostridium (CFU/g feces) | 1,2,4,6,9 and 12 months of age | 
| Regurgitation | Measurement by score: 1 = not at all, 2 = regurgitation of small amounts during or shortly after feeding, 3 = larger regurgitation during or shortly after feeding, 4 = minor vomiting with time-lag to prior feeding, and 5 = severe vomiting with considerable loss of fluid. | each 2 weeks until 6 months of age and monthly until 12 months of age | 
| Fecal deposition | Measurement by score:1 = <1 time, 2 = 1-3, 3 = 4-6, 4 = 7-10, and 5 = >10. | each 2 weeks until 6 months of age and monthly until 12 months of age | 
| Infant colic | Average crying hours per day during the last two days of each period of measurement which is each 2 weeks until 6 months of age and monthly until 12 months of age. Score: no crying; < 3 hours/day;⁯ 3-6 hours/day;⁯ 6-12 hours/day;⁯ > 12 hours/day | each 2 weeks until 6 months of age and monthly until 12 months of age | 
| Flatulency | Average of duration of flatulence episodes (hours per day) during the last two days of each period of measurement which is each 2 weeks until 6 months of age and monthly until 12 months of age.Measurement by the score:no flatulency; < 3 hours/day;⁯ 3-6 hours/day;⁯ 6-12 hours/day;⁯ > 12 hours/day | each 2 weeks until 6 months of age and monthly until 12 months of age | 
| Hours of night sleep | Average of time of night sleep (hours per day) during the last two days of each period of measurement which is each 2 weeks until 6 months of age and monthly until 12 months of age.Measurement by the score:⁯ < 4 hours ; 4-6 hours;⁯ 6-9 hours;⁯ 9-12 hours;⁯ > 12 hours | each 2 weeks until 6 months of age and monthly until 12 months of age | 
| Total hours of sleep/day | ⁯Average of total time of sleep (hours per day) during the last two days of each period of measurement which is each 2 weeks until 6 months of age and monthly until 12 months of age.Measurement by the score:⁯ < 11 hours; ⁯ 11-14 hours; 14-17 hours; 17-20 hours; ⁯ > 20 hours | each 2 weeks until 6 months of age and monthly until 12 months of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infant nutrition, probiotic