A Phase 4 interventional study of Mutaflor® Suspension in Infantile Diarrhea, sponsored by Hospital San Bartolome. Status unknown at 3 sites in Peru. Open to participants aged 3 Hours to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-11-10.
Sponsored by Hospital San Bartolome · Phase 4, Interventional, and Prevention
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 198 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →This is the only study on the registry with Hospital San Bartolome as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Term born infants.
Exclusion criteria:
Severe co-morbidities diseases of the:
Only observation; observation period: 1 year.
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
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.
Also known as: EcN, Mutaflor, Newborn, Nissle, Prophylaxis
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
Time frame: 12 months / first year of life
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.
Time frame: 12 months / first year of life
This study is status unknown, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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