Status:
COMPLETED
Milk Ingredients and Resistance Against E-coli-induced GastroEnteritis (MIRAGE)
Lead Sponsor:
NIZO Food Research
Collaborating Sponsors:
Arla Foods
Denmark
Conditions:
Bacterial Infection
Diarrhea
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
Background: The incidence of gastrointestinal infections is very high. In Western countries at least 30% of the population suffers from at least one food-borne infection per year. Mostly because of th...
Eligibility Criteria
Inclusion
- Signed informed consent
- Age 18-55 yrs
- Availability of internet connection
- Willingness to replace habitual dairy product intake with the supplied low-calcium soy products
- Willingness to abstain from products with high amounts of prebiotic fibers and from products with probiotics starting 1 month prior to study start
- Willingness to give up blood donation from 1 month before the start of the experiment and during the entire experimental period.
Exclusion
- Current or previous underlying disease of the GI tract, liver, bile bladder, kidney, thyroid gland (self-reported)
- Allergy to milk products or lactose intolerance (self-reported), since the capsules may contain milk traces from culture media
- Allergy to soy products (self-reported)
- Use of antibiotics, norit, laxatives (up till 6 months prior to inclusion), cholestyramine, acid burn inhibitors or immune suppressive agents (up till 3 months prior to inclusion), and pre- and probiotics (up till 1 month prior to inclusion).
- High titer serum antibodies against ETEC (10 ml blood sample collected at screening)
- ETEC detected in fecal sample (collected at screening)
- Vegetarians
- Vegans
- Heavy alcohol use (\>4 consumptions/day or \>20/week)
- Drug use
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01800396
Start Date
February 1 2013
End Date
May 1 2013
Last Update
August 27 2015
Active Locations (1)
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1
NIZO food research
Ede, Netherlands, 6718ZB