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

NCT ID: NCT02590991

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-06-29

Brief Summary

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

Detailed Description

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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.

Conditions

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Caesarean Section Born Children

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Prebiotics group

No intervention since is a follow-up study

Prebiotics

Intervention Type OTHER

To study the long term effect of supplementation in early life

Prebiotics & Probiotics group

No intervention since is a follow-up study

Prebiotics & Probiotics

Intervention Type OTHER

To study the long term effect of supplementation in early life

Control group

No intervention since is a follow-up study

No interventions assigned to this group

Interventions

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Prebiotics

To study the long term effect of supplementation in early life

Intervention Type OTHER

Prebiotics & Probiotics

To study the long term effect of supplementation in early life

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

36 Months

Maximum Eligible Age

54 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danone Asia Pacific Holdings Pte, Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mei Chien Chua, Dr

Role: PRINCIPAL_INVESTIGATOR

KK Women's and Children's Hospital

Locations

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KK Women's and Children's hospital

Singapore, , Singapore

Site Status

King Chulalongkorn hospital

Bangkok, , Thailand

Site Status

Countries

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Singapore Thailand

Other Identifiers

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CAE2C/A

Identifier Type: -

Identifier Source: org_study_id

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