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Cesarean Section Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01992497
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Nestlé

Tracking Information
First Submitted Date  ICMJE November 19, 2013
First Posted Date  ICMJE November 25, 2013
Last Update Posted Date April 24, 2020
Actual Study Start Date  ICMJE December 2013
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2013)
Number of diarrhea episodes between a probiotic vs. placebo [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2013)
Diarrhea duration between a probiotic vs. placebo [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cesarean Section Study
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Diarrhea
  • Atopic Dermatitis
Intervention  ICMJE Dietary Supplement: Probiotic
Study Arms  ICMJE
  • Placebo Comparator: Formula + placebo
    Intervention: Dietary Supplement: Probiotic
  • Experimental: Formula + probiotic
    Formula + probiotic
    Intervention: Dietary Supplement: Probiotic
  • Experimental: Breastfed + probiotic
    Breastfed + probiotic
    Intervention: Dietary Supplement: Probiotic
  • Placebo Comparator: Breastfed + placebo
    Intervention: Dietary Supplement: Probiotic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2019)
721
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2013)
740
Actual Study Completion Date  ICMJE December 2019
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 24 Hours   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01992497
Other Study ID Numbers  ICMJE 12.14.INF
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nestlé
Study Sponsor  ICMJE Nestlé
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nestlé
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP