Cesarean Section Study

April 22, 2020 updated by: Société des Produits Nestlé (SPN)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

721

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Potsdam, Germany, 14467
        • Klinikum Ernst v. Bergmann GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 1 day (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Formula + placebo
Dietary supplement: Probiotic
Experimental: Formula + probiotic
Dietary supplement: Probiotic
Experimental: Breastfed + probiotic
Dietary supplement: Probiotic
Placebo Comparator: Breastfed + placebo
Dietary supplement: Probiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of diarrhea episodes between a probiotic vs. placebo
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Diarrhea duration between a probiotic vs. placebo
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société des Produits Nestlé (SPN)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

November 19, 2013

First Submitted That Met QC Criteria

November 19, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Actual)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 22, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12.14.INF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diarrhea

Clinical Trials on Probiotic

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe