Prophylaxis of Gastrointestinal Infections With EcN

Infantile Diarrhea Clinical Trial

— PIURA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01469273
• Other study ID #: MU 0932 BL
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 8, 2011
• Last updated: November 9, 2011
• Start date: November 2011
• Est. completion date: December 2013

Study information

• Verified date: November 2011
• Source: Hospital San Bartolome
• Contact: Delfina Cetraro, MD
• Phone: +51 1 4245217
• Email: finacetrarocardo[@]yahoo.es
• Is FDA regulated: No
• Health authority: Peru: Instituto Nacional de Salud
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 198
• Est. completion date: December 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diarrhea, Infantile
• Infantile Diarrhea

Intervention

Drug:
• Mutaflor® Suspension
Application of Mutaflor-Suspension on 10 consecutive days.

Locations

Country	Name	City	State
Peru	Centro de Salud Los Algarrobos	Piura
Peru	Centro de Salud Materno Inftantil de Castilla (CESAMICA)	Piura
Peru	Materno Infantil Santa Rosa	Piura

Sponsors (2)

Lead Sponsor	Collaborator
Hospital San Bartolome	Instituto de Investigacion de las Alteraciones del Crecimiento, Desarrollo y Enfermedades Metabolicas

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes