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Completed

NCT Number: NCT02590991

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

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

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Key information

Conditions

Caesarean Section Born Children

Age range

36 month–54 month

Sex eligibility

All sexes

Study type

Observational

Primary location

KK Women's and Children's hospital, Singapore

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prebiotics

Other

To study the long term effect of supplementation in early life

Prebiotics & Probiotics

Other

To study the long term effect of supplementation in early life

Primary outcomes

  1. Absolute count of Bifidobacterium

    Time frame: 3 - 4 years old

    Difference in absolute count of bifidobacterium between study groups

  2. Absolute level of fecal lactate

    Time frame: 3 - 4 years old

    Difference in absolute level of fecal lactate between study groups

  3. Incidence of allergy manifestation

    Time frame: 3 - 4 years old

    Difference in parent-reported cumulative incidences of allergy manifestation between study groups

  4. Incidence of gastrointestinal symptoms

    Time frame: 3 - 4 years old

    Difference in parent-reported cumulative incidences of gastrointestinal symptoms between study groups

  5. Incidence of infection

    Time frame: 3 - 4 years old

    Difference in parent-reported cumulative incidences of infection between study groups

Sponsors and collaborators

Lead sponsor

Danone Asia Pacific Holdings Pte, Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 29, 2015
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.