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

Caesarean Section Born Children Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02590991
• Other study ID #: CAE2C/A
• Status: Completed
• Start date: November 2015
• Est. completion date: June 29, 2018

Study information

• Verified date: February 2019
• Source: Danone Asia Pacific Holdings Pte, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 29, 2018
• Est. primary completion date: June 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 36 Months to 54 Months

Eligibility

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.

Related Conditions & MeSH terms

• Caesarean Section Born Children

Intervention

Other:
• Prebiotics
To study the long term effect of supplementation in early life
• Prebiotics & Probiotics
To study the long term effect of supplementation in early life

Locations

Country	Name	City	State
Singapore	KK Women's and Children's hospital	Singapore
Thailand	King Chulalongkorn hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Danone Asia Pacific Holdings Pte, Ltd.

Countries where clinical trial is conducted

Singapore,  Thailand, 

Outcome

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