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

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

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

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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

Resource links provided by the National Library of Medicine


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)




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



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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

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Responsible Party: Clasado
ClinicalTrials.gov Identifier: NCT02796872     History of Changes
Other Study ID Numbers: CLA12016CN
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: February 2017