The Effect of Probiotics on E. Coli Gastroenteritis
Condition: Gastroenteritis; Bacterial Infection; Diarrhea
MeSH terms: Infections; Bacterial Infections; Gastroenteritis; Diarrhea
Study type: Interventional

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 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.
    

Detailed description: 
      The timeframes for analysis of the primary and secondary outcomes is mentioned below in the
      Outcome Measures section.
    

Intervention name(s): probiotics; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Freeze-dried powder, dose 10E9 CFU twice daily for 4 weeks; placebo consisting of carrier material powder of identical appearance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: infectious diarrhea; probiotics; prevention; dietary intervention; E. coli infection; intestinal infection; intestinal resistance