Prophylaxis of Gastrointestinal Infections With EcN

Study Overview
=================
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Prophylaxis of Gastrointestinal Infections in Newborn and Infants With a Suspension Containing the Probiotic Escherichia Coli Strain Nissle

Conditions
-----------------
Infantile Diarrhea

Intervention / Treatment
-----------------
* Drug: Mutaflor® Suspension


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 3 Hours
Maximum Age: 12 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Only observation; observation period: 1 year. | |
| Experimental: Early Treatment group (E)<br>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<br>* Application of Mutaflor-Suspension on 10 consecutive days.<br>* Other names: Prophylaxis;|
| Experimental: Late Treatment Group (L)<br>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<br>* Application of Mutaflor-Suspension on 10 consecutive days.<br>* Other names: Prophylaxis;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days with diarrhea | To show prophylaxis with a probiotic suspension containing E. coli strain Nissle against gastrointestinal infections associated with diarrhea within the first 12 months of life compared to an untreated control group. | 12 months / first year of life | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diarrhea, EcN, E. coli strain Nissle 1917, Gastrointestinal infection, Infant, Newborn, Probiotic drug, Prevention, Prophylaxis