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

• Sponsor: Clasado (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02796872
• Collaborator: (none)
• Enrollment: 392
• Arms: 4
• Actual Duration (Months): 11

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dietary Modification	Dietary Supplement: GOS; Dietary Supplement: B-GOS 3%; Dietary Supplement: B-GOS 2%; Dietary Supplement: Mother's breast milk	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 392 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: The Effect of Feeding Infant Formula With Bimuno Galactooligosaccharide (GOS)
• Actual Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: mother's breast milk. 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)

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

Secondary Outcome Measures

1. 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

2. Formula intake [6 months]

   Formula intake (24-hour dietary recall) at 30, 60, 90, 120, 150 and 180 days of age

3. 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.

4. 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)

5. Saliva cortisol, IgA, chromogranin A and lysozyme [6 months]

   Saliva cortisol, IgA, chromogranin A and lysozyme at 30, 90 and 180 days of age

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Days to 18 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Clasado

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Clasado
• ClinicalTrials.gov Identifier: NCT02796872
• Other Study ID Numbers: CLA12016CN
• First Posted: Jun 13, 2016
• Last Update Posted: Jul 19, 2017
• Last Verified: Feb 1, 2017

Study Results

No Results Posted as of Jul 19, 2017