Caesarean Section Born ChildrenNCT02590991
Follow-up Study to Investigate Long Term Effect of Supplementing Pre- and Probiotics in Children Born by C-Section
An observational study of Caesarean Section Born Children, run by Danone Asia Pacific Holdings Pte, Ltd. at 2 sites in 2 countries.
Trial summary
This study investigate the long term effect of supplementation of pre- and probiotics in early life in children born by Caesarean Section. Read more about this study
- Who is it for?
- Ages 36 to 54 monthsHealthy volunteers can take part
- Conditions the study is for
- Caesarean Section Born Children
- What is being tested?
- Prebiotics and Prebiotics & Probiotics
- How many people
- 102 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2015to 29 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 54 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children who had completed Juliu Sn study until 16 weeks of age.
Who may be able to join
- Participation in the Julius SN study until 16 weeks of age
- Written informed consent from parent(s) or legally acceptable representatives
Who cannot join
- Investigator's uncertainty about the willingness or ability of the child and parents to comply with the protocol requirements.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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)
This study investigate the long term effect of supplementation of pre- and probiotics in early life in children born by Caesarean Section.
Read the 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.
- Conditions
- Caesarean Section Born Children
- Being tested
- Prebiotics, Prebiotics & Probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrebioticsOther
To study the long term effect of supplementation in early life
Prebiotics & ProbioticsOther
To study the long term effect of supplementation in early life
| Study group | Role | What they receive |
|---|---|---|
| Prebiotics group | No intervention since is a follow-up study Receives: Other: Prebiotics | |
| Prebiotics & Probiotics group | No intervention since is a follow-up study Receives: Other: Prebiotics & Probiotics | |
| Control group | No intervention since is a follow-up study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute count of Bifidobacterium
Difference in absolute count of bifidobacterium between study groups
Measured: 3 - 4 years old
Absolute level of fecal lactate
Difference in absolute level of fecal lactate between study groups
Measured: 3 - 4 years old
Incidence of allergy manifestation
Difference in parent-reported cumulative incidences of allergy manifestation between study groups
Measured: 3 - 4 years old
Incidence of gastrointestinal symptoms
Difference in parent-reported cumulative incidences of gastrointestinal symptoms between study groups
Measured: 3 - 4 years old
Incidence of infection
Difference in parent-reported cumulative incidences of infection between study groups
Measured: 3 - 4 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startNov 2015
- Primary completion29 Jun 2018
- Study completion29 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean Section Born ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mei Chien Chua, Dr, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590991
- Sponsor's protocol ID
- CAE2C/A
- Status last verified
- Feb 2019
- First submitted
- 14 Sep 2015
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02590991
- Acronym / sponsor ID
- CAE2C/A
- Conditions
- Caesarean Section Born Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 29 Jun 2018 (actual)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prebiotics group | – | Other: PrebioticsNo intervention since is a follow-up study |
| Prebiotics & Probiotics group | – | Other: Prebiotics & ProbioticsNo intervention since is a follow-up study |
| Control group | – | –No intervention since is a follow-up study |
Who may qualify
- Ages
- 36 to 54 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children who had completed Juliu Sn study until 16 weeks of age.
Key inclusion criteria (2 listed)
- Participation in the Julius SN study until 16 weeks of age
- Written informed consent from parent(s) or legally acceptable representatives
Key exclusion criteria (1 listed)
- Investigator's uncertainty about the willingness or ability of the child and parents to comply with the protocol requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrebioticsTo study the long term effect of supplementation in early life | Other | Prebiotics group |
| Prebiotics & ProbioticsTo study the long term effect of supplementation in early life | Other | Prebiotics & Probiotics group |
Primary outcome
Absolute count of Bifidobacterium
Time frame: 3 - 4 years old
Difference in absolute count of bifidobacterium between study groups
Absolute level of fecal lactate
Time frame: 3 - 4 years old
Difference in absolute level of fecal lactate between study groups
Incidence of allergy manifestation
Time frame: 3 - 4 years old
Difference in parent-reported cumulative incidences of allergy manifestation between study groups
Incidence of gastrointestinal symptoms
Time frame: 3 - 4 years old
Difference in parent-reported cumulative incidences of gastrointestinal symptoms between study groups
Incidence of infection
Time frame: 3 - 4 years old
Difference in parent-reported cumulative incidences of infection between study groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei Chien Chua, Dr principal investigator
KK Women's and Children's Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caesarean Section Born Children, run by Danone Asia Pacific Holdings Pte, Ltd. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute count of Bifidobacterium (time frame: 3 - 4 years old). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.