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Prophylaxis of Gastrointestinal Infections With EcN

NCT01469273 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2011-11-10

No results posted yet for this study

Summary

This interventional trial shall investigate the efficacy and tolerance of a suspension with non-pathogenic probiotic E. coli strain Nissle (EcN) on prophylaxis against gastrointestinal infections in newborn and infants. ECN-SUSPENSION is a probiotic containing viable E. coli bacteria of the non-pathogenic Nissle 1917 strain at a concentration of 10exp8 cells per ml.

Conditions

  • Infantile Diarrhea

Interventions

DRUG

Mutaflor® Suspension

Application of Mutaflor-Suspension on 10 consecutive days.

Sponsors & Collaborators

  • Instituto de Investigacion de las Alteraciones del Crecimiento, Desarrollo y Enfermedades Metabolicas

    collaborator OTHER

  • Hospital San Bartolome

    lead OTHER

Principal Investigators

  • Ruth Bindels, MD · Hospital San Bartolome

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Hours
Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-05-31
Completion
2013-12-31

Countries

  • Peru

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01469273 on ClinicalTrials.gov