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

Not Applicable

Completed

• Conditions: Dietary Modification
• Interventions: Dietary Supplement: GOS; Dietary Supplement: B-GOS 2%; Dietary Supplement: Mother's breast milk; Dietary Supplement: B-GOS 3%

• Registration Number: NCT02796872
• Lead Sponsor: Clasado

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-30
• Study Start: 2016-06
• Study First Submitted QC: 2016-06-07
• Study First Posted: 2016-06-13
• Primary Completion: 2016-12
• Status Verified: 2017-02
• Study Completion: 2017-05
• Last Update Submitted: 2017-07-17
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 392

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
other GOS	GOS	Commercial infant formula containing 4% w/w FOS:GOS (1:3)
B-GOS 2%	B-GOS 2%	Commercial infant formula containing 4% w/w FOS:B -GOS (1:3)
mother's breast milk.	Mother's breast milk	mother's breast milk.
B-GOS 3%	B-GOS 3%	Commercial infant formula containing 3% w/w FOS:B -GOS (1:2)

Primary Outcome Measures

Name	Time	Method
Fecal bacteria analysis	6 months	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
Anthropometric parameters	6 months	body length, body weight, and head circumferences at enrollment (15± 3 days of age), 30, 60, 90, 120, 150 and 180 days of age

Secondary Outcome Measures

Name	Time	Method
Formula intake	6 months	Formula intake (24-hour dietary recall) at 30, 60, 90, 120, 150 and 180 days of age
Saliva cortisol, IgA, chromogranin A and lysozyme	6 months	Saliva cortisol, IgA, chromogranin A and lysozyme at 30, 90 and 180 days of age
Fecal sIgA and SCFA analysis	6 months	Fecal sIgA and SCFA analysis at 30 days of age (visit 1) and 180 days of age (visit 6)
Dietary	6 months	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
All medically confirmed adverse events and antibiotic record	6 months	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.