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Prophylaxis of Gastrointestinal Infections With EcN (PIURA)

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ClinicalTrials.gov Identifier: NCT01469273
Recruitment Status : Unknown
Verified November 2011 by Hospital San Bartolome.
Recruitment status was:  Not yet recruiting
First Posted : November 10, 2011
Last Update Posted : November 10, 2011
Sponsor:
Collaborator:
Instituto de Investigacion de las Alteraciones del Crecimiento, Desarrollo y Enfermedades Metabolicas
Information provided by (Responsible Party):
Hospital San Bartolome

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infantile Diarrhea Drug: Mutaflor® Suspension Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2011
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Number of diarrhea episodes [ Time Frame: 12 months / first year of life ]
    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 :
  1. Number of days with diarrhea [ Time Frame: 12 months / first year of life ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01469273


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

Locations
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Peru
Centro de Salud Los Algarrobos
Piura, Peru
Contact: Segundo Montoya, MD    +51 7335 1635      
Principal Investigator: Segundo Montoya, MD         
Centro de Salud Materno Inftantil de Castilla (CESAMICA)
Piura, Peru
Contact: Luis Luna, MD         
Principal Investigator: Luis Luna, MD         
Materno Infantil Santa Rosa
Piura, Peru
Contact: Marco Luna, MD         
Principal Investigator: Marco Luna, MD         
Sponsors and Collaborators
Hospital San Bartolome
Instituto de Investigacion de las Alteraciones del Crecimiento, Desarrollo y Enfermedades Metabolicas
Investigators
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Principal Investigator: Ruth Bindels, MD Hospital San Bartolome
More Information
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Responsible Party: Hospital San Bartolome
ClinicalTrials.gov Identifier: NCT01469273    
Other Study ID Numbers: MU 0932 BL
First Posted: November 10, 2011    Key Record Dates
Last Update Posted: November 10, 2011
Last Verified: November 2011
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:
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Infection
Diarrhea
Diarrhea, Infantile
Signs and Symptoms, Digestive