NCT01469273

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
198

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2011

Typical duration for phase_4

Geographic Reach
1 country

3 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

November 10, 2011

Status Verified

November 1, 2011

Enrollment Period

1.5 years

First QC Date

November 8, 2011

Last Update Submit

November 9, 2011

Conditions

Infantile Diarrhea

Keywords

DiarrheaEcNE. coli strain Nissle 1917Gastrointestinal infectionInfantNewbornProbiotic drugPreventionProphylaxis

Outcome Measures

Primary Outcomes (1)

  • Number of diarrhea episodes

    To show superiority of a prophylaxis with a probiotic suspension containing E. coli strain Nissle against gastrointestinal infections associated with diarrhea, compared to an untreated control group

    12 months / first year of life

Secondary Outcomes (1)

  • Number of days with diarrhea

    12 months / first year of life

Study Arms (3)

Control group

NO INTERVENTION

Only observation; observation period: 1 year.

Early Treatment group (E)

EXPERIMENTAL

1 x 1 ml of EcN suspension/day on 10 consecutive days, application in the morning before feeding/nursing, first application 48h after birth, latest. Observation period: 1 year.

Drug: Mutaflor® Suspension

Late Treatment Group (L)

EXPERIMENTAL

1 x 1 ml of EcN suspension/day on 10 consecutive days, application in the morning after feeding/nursing, starting on the first day of the 7th month of life. Observation period: 1 year.

Drug: Mutaflor® Suspension

Interventions

Mutaflor® SuspensionDRUG

Application of Mutaflor-Suspension on 10 consecutive days.

Also known as: EcN, Mutaflor, Newborn, Nissle, Prophylaxis
Early Treatment group (E)Late Treatment Group (L)

Eligibility Criteria

Age3 Hours - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Informed consent form signed by the patient's parents or legal guardians.
  • Term born infants.
  • Age \< 2 days
  • Gestational age from 38-42 weeks of gestation
  • Birth weight from 2500-3750 gr.
  • Normal delivery (eutocia)

You may not qualify if:

  • Simultaneous participation in another clinical study
  • Consumption of food supplements or medicines containing live micro-organisms or their metabolic products or components during the study
  • Autoimmune disease·Severe sepsis or severe systemic injury
  • Immunosuppressive treatment
  • Severe co-morbidities diseases of the:
  • Heart
  • Liver
  • Kidney
  • Genetic disease
  • Other serious associated diseases, which in the opinion of the investigator, cast a doubt on the implementation of the test according to the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centro de Salud Los Algarrobos

Piura, Piura, Peru

Location

Centro de Salud Materno Inftantil de Castilla (CESAMICA)

Piura, Piura, Peru

Location

Materno Infantil Santa Rosa

Piura, Piura, Peru

Location

MeSH Terms

Conditions

Diarrhea, InfantileDiarrhea

Interventions

17-hydroxyestrane-3-carbonitrile

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ruth Bindels, MD

    Hospital San Bartolome

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Delfina Cetraro, MD

CONTACT

+51 1 4245217finacetrarocardo@yahoo.es

Eleana Calderon, CRA

CONTACT

+51 1 986674496eleana_calderon@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2011

First Posted

November 10, 2011

Study Start

November 1, 2011

Primary Completion

May 1, 2013

Study Completion

December 1, 2013

Last Updated

November 10, 2011

Record last verified: 2011-11

Locations

PE(3)