Skip to main content
OpenTrials
Completed

NCT Number: NCT02796872

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

12 day–18 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GOS

Dietary Supplement

GOS resource (β-galactosidase from Bacillus circulans) Commercial infant formula containing 4% w/w FOS:GOS (1:3)

B-GOS 3%

Dietary Supplement

Bimuno-GOS (B-GOS) resource (β-galactosidase from Bifidobacteriumbifidum) Commercial infant formula containing 3% w/w FOS:B -GOS (1:2)

B-GOS 2%

Dietary Supplement

Bimuno-GOS (B-GOS) resource (β-galactosidase from Bifidobacteriumbifidum) Commercial infant formula containing 4% w/w FOS:B -GOS (1:3)

Mother's breast milk

Dietary Supplement

exclusively breastfed infants for at least 7 days prior to enrollment

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Clasado

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jun 13, 2016
Registry last updated
Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.