Diarrhea Clinical Trial
Official title:
The Effect of Probiotics on E. Coli Gastroenteritis
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 human resistance to gut infections as they may beneficially modulate the
intestinal microbiota composition and activity, and the immune function upon intestinal
infection.
Aim:
To study whether probiotics improve the resistance of humans to enterotoxigenic E. coli
(ETEC).
Study design:
The PRETEC study is a parallel, double-blind, placebo-controled 4-weeks intervention with
probiotics in healthy volunteers. In this study, the effect of probiotic intervention vs
placebo on several infection markers in response to an ETEC challenge is investigated.
Participants will be randomly assigned to the probiotic or placebo group (n=21 per group).
Subjects will be instructed to maintain 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 10E10 CFU). This ETEC strain induces mild and short-lived infectious
diarrhea symptoms. Before and after infection, a diary will be kept to write down 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. Blood is sampled for immune response analyses and multiple faecal samples are
collected to quantify several infection- and immune system markers, to determine probiotic
excretion, and to verify dietary calcium intake.
Study population:
Healthy males of 20-55 yrs of age.
Interventions:
Probiotics (freeze-dried powder, dose 10E9 CFU twice daily) or placebo (carrier material
powder of identical appearance).
Primary outcomes:
Total fecal ETEC excretion per day and severity of diarrhea (quantified by faecal output per
day).
Secondary outcomes:
Serum immune response to ETEC, self-reported stool consistency scores and gastrointestinal
complaints, relative faecal wet weight, sIgA and calprotectin in faeces, probiotic
persistence and levels of opportunistic pathogens in the endogenous microbiota.
The timeframes for analysis of the primary and secondary outcomes is mentioned below in the Outcome Measures section. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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