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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

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.

Condition or disease Intervention/treatment Phase
Diarrhea Atopic Dermatitis Dietary Supplement: Probiotic Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 721 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : December 2013
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Formula + placebo Dietary Supplement: Probiotic
Experimental: Formula + probiotic
Formula + probiotic
Dietary Supplement: Probiotic
Experimental: Breastfed + probiotic
Breastfed + probiotic
Dietary Supplement: Probiotic
Placebo Comparator: Breastfed + placebo Dietary Supplement: Probiotic



Primary Outcome Measures :
  1. Number of diarrhea episodes between a probiotic vs. placebo [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Diarrhea duration between a probiotic vs. placebo [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992497


Locations
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Germany
Klinikum Ernst v. Bergmann GmbH
Potsdam, Germany, 14467
Sponsors and Collaborators
Nestlé
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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01992497    
Other Study ID Numbers: 12.14.INF
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Keywords provided by Nestlé:
Cesarean section, probiotic, formula fed, gut microbiota
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Diarrhea
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Signs and Symptoms, Digestive