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

A Follow-up Clinical Study to Investigate the Long Term Effect of Supplementation of Pre- and Probiotics in Early Life in Children Born by Caesarean Section (Julius SN Follow-up 1)

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

Study Overview

• Status: Completed
• Conditions: Caesarean Section Born Children
• Intervention / Treatment: Other: Prebiotics; Other: Prebiotics & Probiotics

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 Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 229899
    • KK Women's and Children's Hospital
• Thailand
  • Bangkok, Thailand
    • King Chulalongkorn Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children who had completed Juliu Sn study until 16 weeks of age.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prebiotics group; No intervention since is a follow-up study	Other: Prebiotics; To study the long term effect of supplementation in early life
Prebiotics & Probiotics group; No intervention since is a follow-up study	Other: Prebiotics & Probiotics; To study the long term effect of supplementation in early life
Control group; No intervention since is a follow-up study

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Danone Asia Pacific Holdings Pte, Ltd.
• Investigators: Principal Investigator: Mei Chien Chua, Dr, KK Women's and Children's Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): June 29, 2018
• Study Completion (Actual): June 29, 2018

Study Registration Dates

• First Submitted: September 14, 2015
• First Submitted That Met QC Criteria: October 28, 2015
• First Posted (Estimate): October 29, 2015

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 11, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CAE2C/A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No