Cesarean Section Study | NCT01992497

Studies
Cesarean Section Study

NCT01992497

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Apr 24, 2020Actual

Enrollment

721Actual

Phase

Not Applicable

Conditions

Diarrhea
Atopic Dermatitis

Interventions

Probiotic

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013Actual

Primary Completion Date

Dec 2019Actual

Completion Date

Dec 2019Actual

First Submitted Date

Nov 19, 2013

First Submission Date that Met QC Criteria

Nov 19, 2013

First Posted Date

Nov 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2020

Last Update Posted Date

Apr 24, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

721Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Formula + placebo	Placebo Comparator		Dietary Supplement: Probiotic
Formula + probiotic	Experimental	Formula + probiotic	Dietary Supplement: Probiotic
Breastfed + probiotic	Experimental	Breastfed + probiotic	Dietary Supplement: Probiotic
Breastfed + placebo	Placebo Comparator		Dietary Supplement: Probiotic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Probiotic	Dietary Supplement		Breastfed + placebo Breastfed + probiotic Formula + placebo Formula + probiotic

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Minute

Maximum Age

24 Hours

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum Ernst v. Bergmann GmbH		Potsdam		14467	Germany

Condition Browse Module

MeSH Terms

ID	Term
D003967	Diarrhea
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D012873	Skin Diseases, Genetic

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019936	Probiotics

Ancestor Terms

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided