The Effect of Feeding Infant Formula With Bimuno Galactooligosaccharide (GOS)

This survey is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective trial and is intended to evaluate the Bimuno GOS effects on growth, tolerance, gut health, fecal flora and immune function.

Study Overview

• Status: Completed
• Conditions: Dietary Modification
• Intervention / Treatment: Dietary supplement: Mother's breast milk; Dietary supplement: GOS; Dietary supplement: B-GOS 3%; Dietary supplement: B-GOS 2%

• Study Type: Interventional
• Enrollment (Actual): 392
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• o 15 ± 3 days of age at randomization, inclusive (day of birth is considered day 0)

  • Singleton birth
  • Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age)
  • Birth weight of 2500g to 4000g
  • Signed informed consent obtained for infant's participation in the survey
  • Parent or guardian of infant agrees not to enroll infant in another interventional clinical research survey while participating in this survey
  • APGAR score after 5 minutes of life > 7
  • Consuming only one source of nutrition
  • Formula-fed infant: Infant consuming infant formula as the sole source of nutrition for 7 consecutive days prior to randomization
  • Breastfed infant: Infant consuming mother's breast milk as the sole source of nutrition for 7 consecutive days prior to registration

Exclusion Criteria:

• Infant with inborn malformation and with hereditary and/or chronic and/or inborn diseases requiring hospital care superior to 7 days
• Diseases jeopardizing intrauterine growth
• Weight at Visit 1 is <95% of birth weight [(weight at Visit 1÷birth weight) x 100 <95%]
• Infant born from mother suffering from metabolic and/or chronic diseases
• Infant with an acute infection or gastroenteritis at time of randomization or registration
• Infant consuming supplemental foods
• Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake at time of randomization or registration
• Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others) and children with known head/brain disease/injury such as Microcephaly, Macrocephaly or others

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: mother's breast milk.	Dietary supplement: Mother's breast milk; exclusively breastfed infants for at least 7 days prior to enrollment
Active Comparator: other GOS; Commercial infant formula containing 4% w/w FOS:GOS (1:3)	Dietary supplement: GOS; GOS resource (β-galactosidase from Bacillus circulans) Commercial infant formula containing 4% w/w FOS:GOS (1:3)
Experimental: B-GOS 3%; Commercial infant formula containing 3% w/w FOS:B -GOS (1:2)	Dietary supplement: B-GOS 3%; Bimuno-GOS (B-GOS) resource (β-galactosidase from Bifidobacteriumbifidum) Commercial infant formula containing 3% w/w FOS:B -GOS (1:2)
Experimental: B-GOS 2%; Commercial infant formula containing 4% w/w FOS:B -GOS (1:3)	Dietary supplement: B-GOS 2%; Bimuno-GOS (B-GOS) resource (β-galactosidase from Bifidobacteriumbifidum) Commercial infant formula containing 4% w/w FOS:B -GOS (1:3)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric parameters	body length, body weight, and head circumferences at enrollment (15± 3 days of age), 30, 60, 90, 120, 150 and 180 days of age	6 months
Fecal bacteria analysis	o Fecal bacteria analysis of Bifidobacterium, Lactobacillus, Clostridium perfringens and Escherichia coli at the enrollment 30 days of age ,120 days of age and 180 days of age	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary	tool characteristics, tolerance, formula acceptance, stress and 3-day well-being (quality of life) questionnaire prior to each survey visit recorded at 30, 60, 90, 120, 150 and 180 days of age	6 months
Formula intake	Formula intake (24-hour dietary recall) at 30, 60, 90, 120, 150 and 180 days of age	6 months
All medically confirmed adverse events and antibiotic record	All medically confirmed adverse events including crying, gaseous colics, regurgitation, vomit, skin rashes, fever and concomitant medications recorded on medical records as a measure of safety and tolerability throughout the survey period.	6 months
Fecal sIgA and SCFA analysis	Fecal sIgA and SCFA analysis at 30 days of age (visit 1) and 180 days of age (visit 6)	6 months
Saliva cortisol, IgA, chromogranin A and lysozyme	Saliva cortisol, IgA, chromogranin A and lysozyme at 30, 90 and 180 days of age	6 months

Collaborators and Investigators

• Sponsor: Clasado

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: May 30, 2016
• First Submitted That Met QC Criteria: June 7, 2016
• First Posted (Estimate): June 13, 2016

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 17, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CLA12016CN