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Prophylaxis of Gastrointestinal Infections With EcN (PIURA)

This study is not yet open for participant recruitment.
Verified November 2011 by Hospital San Bartolome
Sponsor:
Collaborator:
Instituto de Investigacion de las Alteraciones del Crecimiento, Desarrollo y Enfermedades Metabolicas
Information provided by (Responsible Party):
Hospital San Bartolome
ClinicalTrials.gov Identifier:
NCT01469273
First received: November 8, 2011
Last updated: November 9, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Infantile Diarrhea
 Drug: Mutaflor® Suspension
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prophylaxis of Gastrointestinal Infections in Newborn and Infants With a Suspension Containing the Probiotic Escherichia Coli Strain Nissle

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Further study details as provided by Hospital San Bartolome:

Primary Outcome Measures:
  • Number of diarrhea episodes [ Time Frame: 12 months / first year of life ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Number of days with diarrhea [ Time Frame: 12 months / first year of life ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 198
Study Start Date: November 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Only observation; observation period: 1 year.
Experimental: 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.
 Drug: Mutaflor® Suspension
Application of Mutaflor-Suspension on 10 consecutive days.
Other Names:
  • EcN
  • Mutaflor
  • Newborn
  • Nissle
  • Prophylaxis
Experimental: 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.
 Drug: Mutaflor® Suspension
Application of Mutaflor-Suspension on 10 consecutive days.
Other Names:
  • EcN
  • Mutaflor
  • Newborn
  • Nissle
  • Prophylaxis

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.

  Eligibility

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469273

Contacts
Contact: Delfina Cetraro, MD +51 1 4245217 finacetrarocardo@yahoo.es
Contact: Eleana Calderon, CRA +51 1 986674496 eleana_calderon@hotmail.com

Locations
Peru
Centro de Salud Los Algarrobos Not yet recruiting
Piura, Peru
Contact: Segundo Montoya, MD     +51 7335 1635        
Principal Investigator: Segundo Montoya, MD            
Materno Infantil Santa Rosa Not yet recruiting
Piura, Peru
Contact: Marco Luna, MD            
Principal Investigator: Marco Luna, MD            
Centro de Salud Materno Inftantil de Castilla (CESAMICA) Not yet recruiting
Piura, Peru
Contact: Luis Luna, MD            
Principal Investigator: Luis Luna, MD            
Sponsors and Collaborators
Hospital San Bartolome
Instituto de Investigacion de las Alteraciones del Crecimiento, Desarrollo y Enfermedades Metabolicas
Investigators
Principal Investigator: Ruth Bindels, MD Hospital San Bartolome
  More Information

No publications provided

Responsible Party: Hospital San Bartolome
ClinicalTrials.gov Identifier: NCT01469273     History of Changes
Other Study ID Numbers: MU 0932 BL
Study First Received: November 8, 2011
Last Updated: November 9, 2011
Health Authority: Peru: Instituto Nacional de Salud

Keywords provided by Hospital San Bartolome:
Diarrhea
EcN
E. coli strain Nissle 1917
Gastrointestinal infection
Infant
 Newborn
Probiotic drug
Prevention
Prophylaxis

Additional relevant MeSH terms:
Diarrhea
Diarrhea, Infantile
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013