PTM202 and Modulation of Host Resistance to Diarrheagenic E. Coli
Condition: Traveler's Diarrhea
MeSH terms: Diarrhea
Study type: Interventional

Summary: 
      The APA12/PANTER study is a parallel 3-weeks intervention study. Subjects will be randomly
      assigned to one of two treatment groups; placebo or PTM202 (n=36 per group). After an
      overnight fast, subjects will be orally infected with a live, but attenuated, diarrheagenic
      E. coli at study day 14. At various time points before and after diarrheagenic E. coli
      challenge an online diary will be kept to record information on stool consistency, frequency
      and severity of symptoms and stool samples will be collected to determine total fecal wet
      weight and percentage of fecal wet weight.
    

Detailed description: 
      The APA12/PANTER study is a randomized, double-blind, placebo-controlled, parallel
      intervention study of 3 weeks in 72 healthy adults. The study will include 2 arms; PTM202 and
      placebo. 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
      overnight fast, subjects will be orally infected with a live, but attenuated, diarrheagenic
      E. coli (strain E1392-75-2A; collection NIZO food research; dose 1E10 CFU (at study day 14).

      At study day 14, 15 and 16 subjects will receive either placebo or PTM202, a dietary formula
      containing dried bovine colostrum and dried whole egg.

      Before and after the diarrheagenic E. coli challenge an online diary will be kept to record
      information on stool consistency, frequency, severity of symptoms and mediation intake. At
      various time points before and after diarrheagenic E. coli challenge stool samples will be
      collected. The main study parameters are Stool consistency (Bristol Stool Scale reported by
      the subjects in the online diary, and Percentage of fecal wet weight (% determined by
      freeze-drying).

      Secondary study parameters are: Stool frequency (Stools per day reported by the subjects in
      the online diary), Total fecal wet weight (fecal weight in g/day), and the incidence and
      severity of Gastro-intestinal symptoms (Gastro-intestinal Symptom Rating Scale reported by
      the subjects in the online diary).
    

Intervention name(s): E. coli strain E1392-75-2A; PTM202
Intervention type(s): Biological; Device
Intervention description(s): After an overnight fast, subjects will be orally infected with a live, but attenuated, diarrheagenic E. coli (strain E1392-75-2A; collection NIZO food research; dose 1E10 CFU (at study day 14).; PTM202 is a dietary formula containing a proprietary mixture of dried bovine colostrum and dried whole egg.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The APA12/PANTER study is a randomized, double-blind, placebo-controlled, parallel intervention study of 3 weeks in 72 healthy adults. Subjects will be orally infected with a live, but attenuated, diarrheagenic E. coli (strain E1392-75-2A; collection NIZO food research; dose 1E10 CFU (at study day 14). At study day 14, 15 and 16 subjects will receive either placebo or PTM202, a dietary formula containing dried bovine colostrum and dried whole egg.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nutrition; Gastroenteritis; Traveler's diarrhea; E. coli