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Prophylaxis of Gastrointestinal Infections With EcN

NCT ID: NCT01469273

Last Updated: 2011-11-10

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Newborns (treatment-group E) and infants at the age of 6 months (treatment-group L) shall be treated with 1 x 1 ml ECN-SUSPENSION for 10 days and observed until the age of 12 months.Treatment-group E (newborn) will receive EcN-Suspension on the first 10 days of life and will be observed for the next 12 months. Treatment-group L (infants at the age of 6 months) will receive EcN-Suspension on the first 10 days of their seventh month of life and will be observed for the next 6 months.The corresponding control group will remain untreated and will be observed only for 12 months. According to the hospitals daily routine the inclusion and exclusion criteria will be checked. All newborns meeting the inclusion criteria will be included into the trial. Patients' anamnestic data and general health status are recorded at the initial control.Controls are performed according to the time schedule normally used in the hospital functioning as a trial site. According to this, during each monthly control data on the efficacy and safety are recorded. The final control for assessing the tolerance and efficacy of the trial medication is conducted along with a physical examination after an observation period of 12 months.In this study, diarrhea is defined as increase of stool frequency to \>3 watery or loose stools in 24 hours on at least two or more consecutive days.The prophylaxis against gastrointestinal infections with EcN-Suspension is expected to result in a decrease of the number episodes of diarrhea in comparison to the untreated control. The primary efficacy criterion is the number of episodes of diarrhea caused by gastrointestinal infection within the first 12 months.

Conditions

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Infantile Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control group

Only observation; observation period: 1 year.

Group Type NO_INTERVENTION

No interventions assigned to this group

Early Treatment group (E)

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.

Group Type EXPERIMENTAL

Mutaflor® Suspension

Intervention Type DRUG

Application of Mutaflor-Suspension on 10 consecutive days.

Late Treatment Group (L)

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.

Group Type EXPERIMENTAL

Mutaflor® Suspension

Intervention Type DRUG

Application of Mutaflor-Suspension on 10 consecutive days.

Interventions

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Mutaflor® Suspension

Application of Mutaflor-Suspension on 10 consecutive days.

Intervention Type DRUG

Other Intervention Names

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EcN Mutaflor Newborn Nissle Prophylaxis

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
* Other reasons which in the opinion of the investigator provide a reason against the inclusion of the patient in 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.
Minimum Eligible Age

3 Hours

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role collaborator

Hospital San Bartolome

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ruth Bindels, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital San Bartolome

Locations

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Centro de Salud Los Algarrobos

Piura, Piura, Peru

Site Status

Centro de Salud Materno Inftantil de Castilla (CESAMICA)

Piura, Piura, Peru

Site Status

Materno Infantil Santa Rosa

Piura, Piura, Peru

Site Status

Countries

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Peru

Central Contacts

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Delfina Cetraro, MD

Role: CONTACT

[email protected]
+51 1 4245217

Eleana Calderon, CRA

Role: CONTACT

[email protected]
+51 1 986674496

Facility Contacts

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Segundo Montoya, MD

Role: primary

+51 7335 1635

Luis Luna, MD

Role: primary

Marco Luna, MD

Role: primary

Other Identifiers

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MU 0932 BL

Identifier Type: -

Identifier Source: org_study_id