Characterization Of Resistance Against Live-attenuated diarrhoeagenic E. coli

Characterization Of Resistance Against Live-attenuated diarrhoeagenic E. coli - CORAL

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42735

Enrollment

Registered

2015-09-01

Start date

2016-01-12

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroenteritis traveller' s diarrhea

Interventions

After a standardized evening meal and an overnight fast, subjects will receive a single oral dose of the attenuated diarrhoeagenic E. coli strain E1392-75-2A (dose will be either 1*10^10 CFU (n=22)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Ability to follow verbal and written instructions; 2. Age between 18 and 55 years; 3. Availability of internet connection; 4. BMI >=20 and

Exclusion criteria

Exclusion criteria: 1. Disease of the GI tract, liver, bile bladder, kidney, thyroid gland (self-reported); 2. Diarrhoeagenic E.coli strain (as used in the study) detected in fecal sample at screening; 3. Evidence of current excessive alcohol consumption or non-therapeutic drug (ab)use); 4. Evidence of IgA deficiency (serum IgA 3 per day; 14. Symptoms consistent with Travelers' Diarrhoea concurrent with travel to countries where ETEC infection is endemic (most of the developing world) within 3 years prior to dosing, OR planned travel to endemic countries during the length of the study. 15. Use of antibiotics, norit, laxatives (up till 6 months prior to inclusion), cholestyramine, antacids, H2 receptor antagonists or proton pump inhibitors or immune suppressive agents (up till 3 months prior to inclusion); 16. Vaccination for or ingestion of ETEC, cholera, or E coli heat labile toxin within 3 years prior to inclusion; 17. Vegetarians and vegans

Design outcomes

Primary

Measure	Time frame
Percentage of faecal dry weight (% determined by freeze-drying)	—

Secondary

Measure	Time frame
• Total faecal wet weight (faecal weight in g/day) • Time to first diarrhoeal stool (reported by the subjects in the online diary) • Stool consistency (Bristol Stool Scale reported by the subjects in the online diary) • Number of stools with Bristol Stool Scale (Bristol Stool Scale reported by the subjects in the online diary) • Stool frequency (Stools per day reported by the subjects in the online diary) • Incidence and duration of WHO-defined diarrhoea (Calculated from the Bristol Stool Scale and the Stool frequency reported by the subjects in the online diary) • Incidence, duration and severity of Gastro-intestinal symptoms (Gastro-intestinal Symptom Rating Scale reported by the subjects in the online diary)	—

Measure

Time frame

• Total faecal wet weight (faecal weight in g/day) • Time to first diarrhoeal stool (reported by the subjects in the online diary) • Stool consistency (Bristol Stool Scale reported by the subjects in the online diary) • Number of stools with Bristol Stool Scale (Bristol Stool Scale reported by the subjects in the online diary) • Stool frequency (Stools per day reported by the subjects in the online diary) • Incidence and duration of WHO-defined diarrhoea (Calculated from the Bristol Stool Scale and the Stool frequency reported by the subjects in the online diary) • Incidence, duration and severity of Gastro-intestinal symptoms (Gastro-intestinal Symptom Rating Scale reported by the subjects in the online diary)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)