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

Completed

• Conditions: Caesarean Section Born Children
• Interventions: Other: Prebiotics; Other: Prebiotics & Probiotics

• Registration Number: NCT02590991
• Lead Sponsor: Danone Asia Pacific Holdings Pte, Ltd.

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2015-09-14
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-29
• Study Start: 2015-11
• Primary Completion: 2018-06-29
• Study Completion: 2018-06-29
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-11
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prebiotics group	Prebiotics	No intervention since is a follow-up study
Prebiotics & Probiotics group	Prebiotics & Probiotics	No intervention since is a follow-up study

Primary Outcome Measures

Name	Time	Method
Incidence of infection	3 - 4 years old	Difference in parent-reported cumulative incidences of infection between study groups
Incidence of gastrointestinal symptoms	3 - 4 years old	Difference in parent-reported cumulative incidences of gastrointestinal symptoms between study groups
Absolute count of Bifidobacterium	3 - 4 years old	Difference in absolute count of bifidobacterium between study groups
Absolute level of fecal lactate	3 - 4 years old	Difference in absolute level of fecal lactate between study groups
Incidence of allergy manifestation	3 - 4 years old	Difference in parent-reported cumulative incidences of allergy manifestation between study groups

Trial Locations

Locations (2)

King Chulalongkorn hospital; 🇹🇭 Bangkok, Thailand

KK Women's and Children's hospital; 🇸🇬 Singapore, Singapore