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NCT01992497 Clinical Trial

Cesarean Section Study

Atopic Dermatitis Clinical Trial

Official title:
Effect,Tolerance and Safety of a Supplementation With a Probiotic in Healthy Newborn Term Infants Born by Cesarean Section Over a 12 Months Period Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01992497
Other study ID # 12.14.INF
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2013
Est. completion date December 2019

Study information
Verified date April 2020
Source Nestlé
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Effect, tolerance and safety of a supplementation with a probiotic on the risk of gastrointestinal infections, on growth, and on gut microbiota in healthy newborn term infants born by Cesarean section. Exploratory comparison between a probiotic vs. placebo in the formula-fed and in the breastfed feeding groups.

Recruitment information / eligibility
Status Completed
Enrollment 721
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 24 Hours
Eligibility Inclusion Criteria:

- written informed consent must be obtained from legal guardian(s) prior to randomization or any study related procedures

- healthy newborns

- born by Cesarean section

- singleton birth

- Age at enrollment in the study < 24h

- birth weight = 2500g and = 4300g

- gestational age = 37 weeks and = 42 weeks

Exclusion Criteria:

- congenital diseases or malformations that may inhibit growth

- prenatal and/or postnatal diseases

- parents are expected to have difficulty complying with the feeding regime

- planned re-admittance to the hospital in the first 14 days of life

- antibiotic treatment at the time of enrollment in the study

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Probiotic

Locations
Country Name City State
Germany Klinikum Ernst v. Bergmann GmbH Potsdam

Sponsors (1)
Lead Sponsor Collaborator
Nestlé

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of diarrhea episodes between a probiotic vs. placebo 12 months
Secondary Diarrhea duration between a probiotic vs. placebo 12 months
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