NCT02796872

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
392

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 13, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

July 19, 2017

Status Verified

February 1, 2017

Enrollment Period

6 months

First QC Date

May 30, 2016

Last Update Submit

July 17, 2017

Conditions

Dietary Modification

Outcome Measures

Primary Outcomes (2)

  • Anthropometric parameters

    body length, body weight, and head circumferences at enrollment (15± 3 days of age), 30, 60, 90, 120, 150 and 180 days of age

    6 months

  • Fecal bacteria analysis

    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

    6 months

Secondary Outcomes (5)

  • Dietary

    6 months

  • Formula intake

    6 months

  • All medically confirmed adverse events and antibiotic record

    6 months

  • Fecal sIgA and SCFA analysis

    6 months

  • Saliva cortisol, IgA, chromogranin A and lysozyme

    6 months

Study Arms (4)

mother's breast milk.

PLACEBO COMPARATOR

mother's breast milk.

Dietary Supplement: Mother's breast milk

other GOS

ACTIVE COMPARATOR

Commercial infant formula containing 4% w/w FOS:GOS (1:3)

Dietary Supplement: GOS

B-GOS 3%

EXPERIMENTAL

Commercial infant formula containing 3% w/w FOS:B -GOS (1:2)

Dietary Supplement: B-GOS 3%

B-GOS 2%

EXPERIMENTAL

Commercial infant formula containing 4% w/w FOS:B -GOS (1:3)

Dietary Supplement: B-GOS 2%

Interventions

GOSDIETARY_SUPPLEMENT

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

other GOS
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 3%
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)

B-GOS 2%
Mother's breast milkDIETARY_SUPPLEMENT

exclusively breastfed infants for at least 7 days prior to enrollment

mother's breast milk.

Eligibility Criteria

Age12 Days - 18 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2016

First Posted

June 13, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2016

Study Completion

May 1, 2017

Last Updated

July 19, 2017

Record last verified: 2017-02