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

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
      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
      probiotics. A specific blend of probiotic lactic acid bacteria (Lactobacillus helveticus
      Rosell-52, Lactobacillus rhamnosus Rosell-11, Bifidobacterium longum Rosell-175) and a
      probiotic yeast (Saccharomyces boulardii), improved stool consistency and shortened the
      duration of diarrhea in a rat model of E.coli-induced diarrhea. These probiotics showed
      synergistic effects compared with administration of solely S. boulardii or a mixture of L.
      helveticus Rosell-52, L. rhamnosus Rosell-11, B. longum Rosell-175. Consumption of S.
      boulardii and a combination of L. helveticus Rosell-52, L. rhamnosus Rosell-11 reduced
      diarrhea in humans.

      Aim:

      To study whether probiotics improves the resistance of humans to enterotoxigenic E. coli
      (ETEC).

      Study design:

      The PROTETEC study is a parallel, double-blind, placebo-controlled 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=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 10E10 CFU). Before and after
      infection, a diary will be kept to record all food and drinks consumption (2x2 days) to
      assess the habitual dietary intake, as well as 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, to determine probiotic excretion, and to verify
      dietary calcium intake.

      Study population:

      Healthy males of 20-55 yrs of age.

      Interventions:

      Probiotics (capsules containing freeze-dried powder, probiotic dose per capsule 5x10E9 CFU;
      twice daily) or placebo (capsules with carrier material powder of identical appearance)

      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.

      Tertiary outcomes:

      sIgA and calprotectin in feces, probiotic persistence and levels of opportunistic pathogens
      in the endogenous microbiota.
    


Intervention name(s): Probiotics; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention