Diarrhea Clinical Trial
Official title:
A Randomized, Placebo-controlled, Double Blind Volunteer Study Into the Effect of Milk Ingredients on Gastroenteritis Caused by an Attenuated E.Coli.
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 the problem of antibiotic resistance, more emphasis is put on prevention
of infections. One of the possibilities is to strengthen human resistance to gut infections
by consumption of milk ingredients.
Aim: To study whether a milk protein concentrate rich in phospholipids improves the
resistance of humans to enterotoxigenic E. coli (ETEC).
Study design: The MIRAGE study is a parallel, double-blind, placebo-controlled 4-weeks
intervention with a milk protein concentrate rich in phospholipids in healthy subjects of
18-55 yrs of age. Participants will be randomly assigned to the milk protein concentrate
rich in phospholipids or placebo group (n=30 per group). Subjects will be instructed to
maintain their usual pattern of physical activity and their habitual food intake, but to
standardize their dietary calcium intake. After an adaptation period of 2 weeks, subjects
will be orally infected with a live, but attenuated, ETEC vaccine (strain E1392-75-2A;
collection NIZO food research; dose will be 1010 CFU). Before and after infection, an online
diary will be kept to record all food and drinks consumption (2x2 days) to assess the
habitual dietary intake. The diary will also be used for daily recording of bowel habits and
frequency and severity of gastrointestinal complaints.
The following biological samples will be collected: 4x10 ml venous blood, a single fecal
bolus (for screening) and 7x24 hrs feces. Blood is sampled for immune response analyses and
the fecal samples are collected to quantify several infection- and immune system markers and
to verify dietary calcium intake. Saliva is sampled three times before and after infection
to quantify immune system markers.
Primary outcomes: Fecal ETEC excretion and severity of diarrhea (quantified by fecal output
per day).
Secondary outcomes: Serum immune response to ETEC, self-reported stool consistency scores
and gastrointestinal complaints, relative fecal wet weight.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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