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)
1 other identifier
observational
102
2 countries
2
Brief Summary
This study investigate the long term effect of supplementation of pre- and probiotics in early life in children born by Caesarean Section.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2015
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2015
CompletedFirst Posted
Study publicly available on registry
October 29, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2018
CompletedFebruary 15, 2019
February 1, 2019
2.7 years
September 14, 2015
February 11, 2019
Conditions
Outcome Measures
Primary Outcomes (5)
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
Study Arms (3)
Prebiotics group
No intervention since is a follow-up study
Prebiotics & Probiotics group
No intervention since is a follow-up study
Control group
No intervention since is a follow-up study
Interventions
To study the long term effect of supplementation in early life
Eligibility Criteria
Children who had completed Juliu Sn study until 16 weeks of age.
You may qualify if:
- Participation in the Julius SN study until 16 weeks of age
- Written informed consent from parent(s) or legally acceptable representatives
You may not qualify if:
- Investigator's uncertainty about the willingness or ability of the child and parents to comply with the protocol requirements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
KK Women's and Children's hospital
Singapore, 229899, Singapore
King Chulalongkorn hospital
Bangkok, Thailand
Biospecimen
Stool samples will be collected from subjects at least once during study visits. Voluntary blood sample will be collected from subjects.
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mei Chien Chua, Dr
KK Women's and Children's Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2015
First Posted
October 29, 2015
Study Start
November 1, 2015
Primary Completion
June 29, 2018
Study Completion
June 29, 2018
Last Updated
February 15, 2019
Record last verified: 2019-02