NCT01992497

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
721

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

6 years

First QC Date

November 19, 2013

Last Update Submit

April 22, 2020

Conditions

DiarrheaAtopic Dermatitis

Keywords

Cesarean section, probiotic, formula fed, gut microbiota

Outcome Measures

Primary Outcomes (1)

  • Number of diarrhea episodes between a probiotic vs. placebo

    12 months

Secondary Outcomes (1)

  • Diarrhea duration between a probiotic vs. placebo

    12 months

Study Arms (4)

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

ProbioticDIETARY_SUPPLEMENT
Breastfed + placeboBreastfed + probioticFormula + placeboFormula + probiotic

Eligibility Criteria

Age1 Minute - 24 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Ernst v. Bergmann GmbH

Potsdam, 14467, Germany

Location

MeSH Terms

Conditions

DiarrheaDermatitis, Atopic

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2013

First Posted

November 25, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations

DE(1)