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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

Tracking Information
First Submitted Date  ICMJE May 30, 2016
First Posted Date  ICMJE June 13, 2016
Last Update Posted Date July 19, 2017
Actual Study Start Date  ICMJE June 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2016)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02796872 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2017)
  • 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
  • Formula intake [ Time Frame: 6 months ]
    Formula intake (24-hour dietary recall) at 30, 60, 90, 120, 150 and 180 days of age
  • 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.
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2016)
  • 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
  • Formula intake [ Time Frame: 6 months ]
    Formula intake (24-hour dietary recall) at 30, 60, 90, 120, 150 and 180 days of age
  • 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.
  • 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)
  • 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
  • Antibody titres against the polio vaccineat [ Time Frame: Antibody titres against the polio vaccineat 180 days of age ]
    Antibody titres against the polio vaccineat 180 days of age
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Feeding Infant Formula With Bimuno Galactooligosaccharide (GOS)
Official Title  ICMJE The Effect of Feeding Infant Formula With Bimuno Galactooligosaccharide (GOS)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Dietary Modification
Intervention  ICMJE
  • Dietary Supplement: GOS
    GOS resource (β-galactosidase from Bacillus circulans) Commercial infant formula containing 4% w/w FOS:GOS (1:3)
  • 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)
  • 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)
  • Dietary Supplement: Mother's breast milk
    exclusively breastfed infants for at least 7 days prior to enrollment
Study Arms  ICMJE
  • Placebo Comparator: mother's breast milk.
    mother's breast milk.
    Intervention: Dietary Supplement: Mother's breast milk
  • Active Comparator: other GOS
    Commercial infant formula containing 4% w/w FOS:GOS (1:3)
    Intervention: Dietary Supplement: GOS
  • Experimental: B-GOS 3%
    Commercial infant formula containing 3% w/w FOS:B -GOS (1:2)
    Intervention: Dietary Supplement: B-GOS 3%
  • Experimental: B-GOS 2%
    Commercial infant formula containing 4% w/w FOS:B -GOS (1:3)
    Intervention: Dietary Supplement: B-GOS 2%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2017)
392
Original Estimated Enrollment  ICMJE
 (submitted: June 7, 2016)
400
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02796872
Other Study ID Numbers  ICMJE CLA12016CN
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clasado
Study Sponsor  ICMJE Clasado
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Clasado
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP