NCT01469273

Prophylaxis of Gastrointestinal Infections With EcN

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Hospital San Bartolome · Academic / Other
• Sex: All
• Age: 3 Hours – 12 Months
• Healthy volunteers: Accepted

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.

Conditions

• Infantile Diarrhea

Interventions

Type	Name	Description
DRUG	Mutaflor® Suspension	Application of Mutaflor-Suspension on 10 consecutive days.

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-05-01
• Completion: 2013-12-01
• First posted: 2011-11-10
• Last updated: 2011-11-10

Locations

3 sites across 1 country: Peru