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

Infant Nutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03204630
• Other study ID #: P024
• Status: Completed
• Phase: N/A
• First received: August 11, 2016
• Last updated: June 28, 2017
• Start date: January 2011
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: Biosearch S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: December 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 5 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Infant Nutrition

Intervention

Dietary Supplement:
• Lfer
Probiotic bacteria originally isolated from breast milk: the strain Lactobacillus fermentum CECT5716
• Bifido
Probiotic bacteria originally isolated from breast milk: the strain Bifidobacterium breve CECT7263

Other:
• Control
Standard infant formula

Locations

Country	Name	City	State
Spain	Hospital Reina Sofía	Córdoba
Spain	Servicio Andaluz de Salud	Granada

Sponsors (3)

Lead Sponsor	Collaborator
Biosearch S.A.	Andaluz Health Service, Maimónides Biomedical Research Institute of Córdoba

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight gain	Body weight gain at 12 months (grams)	12 months versus baseline
Secondary	Length	Length (cm)	1,2,4,6,9 and 12 months of age
Secondary	Body weight	Body weight of infants at different times (kg)	1,2,4,6,9 and 12 months of age
Secondary	Incidence of infections	Events of infections diseases during intervention period (Incidence rate)	total incidence during intervention (11 months)
Secondary	Bacterial load in feces	Counts of Lactobacillus, bifidobacteria, bacteroides, clostridium (CFU/g feces)	1,2,4,6,9 and 12 months of age
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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