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

• ClinicalTrials.gov Identifier: NCT02796872
• Recruitment Status: Completed
• First Posted: June 13, 2016
• Last Update Posted: July 19, 2017
• Sponsor: Clasado
• Information provided by (Responsible Party): Clasado

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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: June 2016
• Actual Primary Completion Date: December 2016
• Actual Study Completion Date: May 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months ]
   Saliva cortisol, IgA, chromogranin A and lysozyme at 30, 90 and 180 days of age

Eligibility Criteria

• Ages Eligible for Study: up to 18 Days (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

No Contacts or Locations Provided

More Information

• Responsible Party: Clasado
• ClinicalTrials.gov Identifier: NCT02796872
• Other Study ID Numbers: CLA12016CN
• First Posted: June 13, 2016
• Last Update Posted: July 19, 2017
• Last Verified: February 2017