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Clinical Trials/ISRCTN66704989
ISRCTN66704989
Completed
未知

Observational single country multi-centre study of pairs of neonate and mother for analysing intestinal microbiota as well as breast milk component

Yakult Honsha European Research Center0 sites111 target enrollmentDecember 17, 2009
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Yakult Honsha European Research Center
Enrollment
111
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 17, 2009
End Date
TBD
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Yakult Honsha European Research Center

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Not specified

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