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| Name | Class |
|---|---|
| PanTheryx, Inc. | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | The placebo will consist of low-lactose isonitrogenous soy product, and will be matched in appearance and flavour to PTM202. 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). |
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| PTM202 | Experimental | PTM202 is a dry powder for reconstitution, comprised of a proprietary mixture of dried bovine colostrum and dried whole egg. 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E. coli strain E1392-75-2A | Biological | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Stool consistency | Change in stool consistency score (questionnaire) before and after E. coli challenge | Before challenge (Day 11-13), After challenge (Day 14-18) |
| Relative fecal wet weight | Change in relative fecal wet weight (freeze-drying) before and after E. coli challenge | Before challenge (Day 11-13), After challenge (Day 14-18) |
| Measure | Description | Time Frame |
|---|---|---|
| Stool frequency | Change in stool frequency (questionnaire) before and after E. coli challenge | Before challenge (Day 11-13), After challenge (Day 14-18) |
| Total fecal wet weight | Change in total fecal wet weight (wet weight measurement) before and after E. coli challenge |
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Inclusion Criteria:
Exclusion Criteria:
Gender identity is self-reported by the subjects through a questionnaire.
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| Name | Affiliation | Role |
|---|---|---|
| Van Schaik | NIZO Food Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIZO | Ede | Gelderland | 6718ZB | Netherlands |
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| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D004927 | Escherichia coli Infections |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
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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.
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All researchers of the project team will be kept blind to assignment of treatment, and so will be the study subjects.The placebo will be matched in appearance and flavour to PTM202.
| PTM202 | Device | PTM202 is a dietary formula containing a proprietary mixture of dried bovine colostrum and dried whole egg. |
|
| Before challenge (Day 11-13), After challenge (Day 14-18) |
| Gastro-intestinal symptoms | Change in gastro-intestinal symptoms (questionnaire) before and after E. coli challenge | Before challenge (Day 11-13), After challenge (Day 14-18) |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |