Status:
COMPLETED
The Effect of Probiotics on E. Coli Gastroenteritis
Lead Sponsor:
NIZO Food Research
Collaborating Sponsors:
Danisco
Conditions:
Gastroenteritis
Bacterial Infection
Eligibility:
MALE
20-55 years
Phase:
NA
Brief Summary
Background: The incidence of gastrointestinal infections is very high. In European countries 10-25% of the population suffers from at least one foodborne infection per year. Probiotics may strengthen...
Detailed Description
The timeframes for analysis of the primary and secondary outcomes is mentioned below in the Outcome Measures section.
Eligibility Criteria
Inclusion
- Signed informed consent
- Male
- Age 20-55 yrs
- Willingness to replace habitual dairy product intake with the supplied low- calcium soy milk products
- Willingness to abstain from products with high amounts of prebiotic fibers and products with probiotics (except for the supplied one)
Exclusion
- Current or previous underlying disease of the GI tract
- lactose intolerance
- Use of antibiotics, norit, laxatives, cholestyramine, acid burn inhibitors, immune suppressiva, prebiotics, probiotics
- detectable serum antibodies against ETEC
- carriage of streptomycin-resistant E. coli in faeces (only relevant when culturing technique for ETEC will be applied instead of specific RT-PCR)
- vegetarians
- heavy alcohol use
- drug use
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01225042
Start Date
October 1 2010
End Date
April 1 2011
Last Update
August 27 2015
Active Locations (1)
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1
NIZO food research
Ede, Netherlands, 6718 ZB