Cesarean Section Study

NCT ID: NCT01992497

Last Updated: 2020-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

721 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Diarrhea Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Formula + placebo

Group Type PLACEBO_COMPARATOR

Probiotic

Intervention Type DIETARY_SUPPLEMENT

Formula + probiotic

Formula + probiotic

Group Type EXPERIMENTAL

Probiotic

Intervention Type DIETARY_SUPPLEMENT

Breastfed + probiotic

Breastfed + probiotic

Group Type EXPERIMENTAL

Probiotic

Intervention Type DIETARY_SUPPLEMENT

Breastfed + placebo

Group Type PLACEBO_COMPARATOR

Probiotic

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Probiotic

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

1 Minute

Maximum Eligible Age

24 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Klinikum Ernst v. Bergmann GmbH

Potsdam, , Germany

Site Status

Countries

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Germany

Other Identifiers

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12.14.INF

Identifier Type: -

Identifier Source: org_study_id

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