Follow-up Study to Investigate Long Term Effect of Supplementing Pre- and Probiotics in Children Born by C-Section

Danone Asia Pacific Holdings Pte, Ltd.102 enrolled

Overview

This study investigate the long term effect of supplementation of pre- and probiotics in early life in children born by Caesarean Section.

This is an extension of investigation on the long term effect of supplementation of pre- and probiotics in early life in children born by Caesarean Section from an earlier completed study.

Study Type

OBSERVATIONAL

Enrollment

102

Conditions

Caesarean Section Born Children

Interventions

PrebioticsOTHER

To study the long term effect of supplementation in early life

Prebiotics & ProbioticsOTHER

To study the long term effect of supplementation in early life

Eligibility

Sex: ALLMin age: 36 MonthsMax age: 54 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Participation in the Julius SN study until 16 weeks of age * Written informed consent from parent(s) or legally acceptable representatives Exclusion Criteria: * Investigator's uncertainty about the willingness or ability of the child and parents to comply with the protocol requirements.

Locations (2)

KK Women's and Children's hospital

Singapore, Singapore

King Chulalongkorn hospital

Bangkok, Thailand

Outcomes

Primary Outcomes

Absolute count of Bifidobacterium

Difference in absolute count of bifidobacterium between study groups

Time frame: 3 - 4 years old

Absolute level of fecal lactate

Difference in absolute level of fecal lactate between study groups

Time frame: 3 - 4 years old

Incidence of allergy manifestation

Difference in parent-reported cumulative incidences of allergy manifestation between study groups

Time frame: 3 - 4 years old

Incidence of gastrointestinal symptoms

Difference in parent-reported cumulative incidences of gastrointestinal symptoms between study groups

Time frame: 3 - 4 years old

Incidence of infection

Difference in parent-reported cumulative incidences of infection between study groups

Time frame: 3 - 4 years old

Data from ClinicalTrials.gov

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