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Cesarean Section Study

Primary Purpose

Diarrhea, Atopic Dermatitis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Probiotic
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diarrhea focused on measuring Cesarean section, probiotic, formula fed, gut microbiota

Eligibility Criteria

1 Minute - 24 Hours (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Klinikum Ernst v. Bergmann GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Arm Label

Formula + placebo

Formula + probiotic

Breastfed + probiotic

Breastfed + placebo

Arm Description

Formula + probiotic

Breastfed + probiotic

Outcomes

Primary Outcome Measures

Number of diarrhea episodes between a probiotic vs. placebo

Secondary Outcome Measures

Diarrhea duration between a probiotic vs. placebo

Full Information

First Posted
November 19, 2013
Last Updated
April 22, 2020
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT01992497
Brief Title
Cesarean Section Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 2013 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Atopic Dermatitis
Keywords
Cesarean section, probiotic, formula fed, gut microbiota

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
721 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Formula + placebo
Arm Type
Placebo Comparator
Arm Title
Formula + probiotic
Arm Type
Experimental
Arm Description
Formula + probiotic
Arm Title
Breastfed + probiotic
Arm Type
Experimental
Arm Description
Breastfed + probiotic
Arm Title
Breastfed + placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Primary Outcome Measure Information:
Title
Number of diarrhea episodes between a probiotic vs. placebo
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Diarrhea duration between a probiotic vs. placebo
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Klinikum Ernst v. Bergmann GmbH
City
Potsdam
ZIP/Postal Code
14467
Country
Germany

12. IPD Sharing Statement

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Cesarean Section Study

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