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

Danone

Status: Completed

Conditions: Caesarean Section Born Children

Treatments: Other: Prebiotics & Probiotics; Other: Prebiotics

Study type: Observational

Funder types: Industry

Identifiers

NCT02590991

CAE2C/A

Details and patient eligibility

About

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

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 36 to 54 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

102 participants in 3 patient groups

Prebiotics group

Description:

No intervention since is a follow-up study

Treatment:

Other: Prebiotics

Prebiotics & Probiotics group

Description:

No intervention since is a follow-up study

Treatment:

Other: Prebiotics & Probiotics

Control group

Description:

No intervention since is a follow-up study