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

Dietary Modification Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02796872
• Other study ID #: CLA12016CN
• Status: Completed
• Phase: N/A
• First received: May 30, 2016
• Last updated: July 17, 2017
• Start date: June 2016
• Est. completion date: May 2017

Study information

• Verified date: February 2017
• Source: Clasado
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 392
• Est. completion date: May 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Days

Eligibility

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

Related Conditions & MeSH terms

• Dietary Modification

Intervention

Dietary Supplement:
• GOS
GOS resource (ß-galactosidase from Bacillus circulans) Commercial infant formula containing 4% w/w FOS:GOS (1:3)
• B-GOS 3%
Bimuno-GOS (B-GOS) resource (ß-galactosidase from Bifidobacteriumbifidum) Commercial infant formula containing 3% w/w FOS:B -GOS (1:2)
• B-GOS 2%
Bimuno-GOS (B-GOS) resource (ß-galactosidase from Bifidobacteriumbifidum) Commercial infant formula containing 4% w/w FOS:B -GOS (1:3)
• Mother's breast milk
exclusively breastfed infants for at least 7 days prior to enrollment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Clasado

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Formula intake	Formula intake (24-hour dietary recall) at 30, 60, 90, 120, 150 and 180 days of age	6 months
Secondary	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
Secondary	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
Secondary	Saliva cortisol, IgA, chromogranin A and lysozyme	Saliva cortisol, IgA, chromogranin A and lysozyme at 30, 90 and 180 days of age	6 months