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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02590991

Enrollment

102

Registered

2015-10-29

Start date

2015-11-30

Completion date

2018-06-29

Last updated

2019-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caesarean Section Born Children

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.

Interventions

OTHERPrebiotics

To study the long term effect of supplementation in early life

OTHERPrebiotics & Probiotics

To study the long term effect of supplementation in early life

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

36 Months to 54 Months

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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
Incidence of gastrointestinal symptoms	3 - 4 years old	Difference in parent-reported cumulative incidences of gastrointestinal symptoms between study groups
Incidence of infection	3 - 4 years old	Difference in parent-reported cumulative incidences of infection between study groups

Countries

Singapore, Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026