YAK.1.C.A: The colonisation of the intestine in childre

Not Applicable

Completed

• Conditions: Intestinal microbiota; Digestive System

• Registration Number: ISRCTN66704989
• Lead Sponsor: Yakult Honsha European Research Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-17
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

1. Healthy pregnant female at 24 weeks of pregnancy
2. Normal course of pregnancy
3. Written Informed Consent dated and signed by the mother
4. Good physical and mental health status as determined by medical history and general clinical examination according to the investigators judgment
5. Considered as reliable and capable of adhering to the protocol, according to the investigator

Exclusion Criteria

1. Birth in water
2. Participation in another clinical trial during the study or within 60 days before delivery
3. Alcohol consumption of more than 7 units per week (1 unit being a glass of beer, wine or a measure of spirits)
4. Reported current usage of illegal drugs
After delivery:
1. Prematurely-born neonate (before 37 weeks of pregnancy)
2. In case a subject has decided to resign from further participation in the study
3. In case a subject suffers from a bacterial/viral infection within 2 weeks before delivery
4. In case a subject delivers a baby with major congenial malformation(s)
5. In case the subject and/or the baby use immunomodulatory drugs between 4 weeks prior to delivery and the end of the study (6 months after delivery)
6. In case the subject and/or the baby use antibiotics between 2 weeks prior to delivery and 2 weeks after the delivery, for any reason except for a prophylactic use (e.g. caesarean section)

Study & Design

• Study Type: Observational
• Study Design: Not specified