Clinical Trials Logo

Clinical Trial Summary

Heat stable toxin (ST) producing ETEC strains are important causes of childhood diarrhea in many countries. Vaccine candidates targeting ST are in development. A human challenge model using an epidemiologically relevant enterotoxigenic E.coli (ETEC) strain expressing ST, but not other diarrhea inducing toxins like heat labile toxin (LT), is necessary to perform an early and efficient evaluation of an ST-toxoid based vaccine.

In this controlled human infection study the investigators will assess the safety of a ST-only producing ETEC strain and the dose needed to achieve an attack rate of 70% in healthy human volunteers.


Clinical Trial Description

The investigators have evaluated the ST-only ETEC strain TW10722 in volunteers previously, and will also evaluate the ETEC strain TW11681, an ETEC family 8, serotype O19:H45, expressing STh, CFA/I, and CS21. These strains have been selected because it is a good representative of one of the most important ETEC families commonly associated with childhood ETEC diarrhea. The TW10722 will also be evaluated at higher dose if TW11681 does not work well.

After screening including routine blood sampling, intestinal lavage and pre-challenge sampling will be done. Volunteers will then be admitted three at a time to Haukeland University Hospital and isolated before receiving the oral bacterial inoculum doses, starting with 10^6 and increasing one log per round until a safe dose that elicits diarrhoea is found. Fine adjustment of the dose needed for a diarrhea attack rate of 70% will then be done in the remaining volunteers. Volunteers will be monitored for a range of symptoms, stool output and adverse events.

Antibiotic treatment will be administered at certain predetermined severities of diarrheal disease, or after 5 days to eradicate the ETEC infection in all volunteers before leaving the hospital. Volunteers will be monitored and sampled again at day 10, 28 and 365 after infection. Serum, plasma, stool, intestinal lavage and PBMC samples will be obtained before, during and after the ETEC infection to evaluate immune responses and potential correlates of protection. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02870751
Study type Interventional
Source University of Bergen
Contact Kurt Hanevik, MD, PhD
Phone +4793856690
Email kurt.hanevik@med.uib.no
Status Recruiting
Phase Phase 1
Start date May 2016
Completion date September 2019

See also
  Status Clinical Trial Phase
Terminated NCT00732732 - A Controlled Trial of Plantain Powder in Infantile Diarrhea N/A
Not yet recruiting NCT03598010 - Safety, Tolerability and Preliminary Efficacy of Lenodiar Pediatric in Diarrhea N/A
Recruiting NCT04654832 - IVC Index in Patient With Diarrhea and Dehydration And How It Affects Its Management
Completed NCT04061538 - Efficiency and Safety of Zinc Sulphate to Reduce the Duration of Acute Diarrheal Disease Between 6 and 59 Months of Age N/A
Completed NCT05322655 - PAthogen Transmission and Health Outcome Models of Enteric Disease
Completed NCT01345695 - Bihar Evaluation of Social Franchising and Telemedicine N/A
Recruiting NCT04528303 - Whole Genome Sequencing Versus Whole Exome Sequencing for Congenital Diarrhea and Enteropahty N/A
Completed NCT04335877 - Effect of Prompting the Supply of Zinc/LO-ORS Co-packs in the Private Sector Plus BCI on Childhood Diarrhea Treatment N/A
Active, not recruiting NCT03012048 - Effectiveness of Point-of-use Water Treatment Technologies to Prevent Stunting Among Children in South Africa N/A
Completed NCT04677296 - Efficacy and Safety of "VS002A" With the Standard WHO-ORS in Non-cholera Acute Watery Diarrhea in Infants and Young Children N/A
Completed NCT04209751 - Descriptive Study of Pathogens Involved in Summer Diarrhea in Children Leading to Pediatric Emergency Room Visits (PE-DIA)
Completed NCT00447161 - Preventing Antibiotic-Associated DiarRhea Using Erceflora Phase 4
Recruiting NCT05766826 - Coupons for Safe Water Project N/A
Terminated NCT04628819 - Effect and Tolerability of Lactobacillus Rhamnosus GG LA801 for the Preventive Nutritional Care of Nosocomial Diarrhea in Children N/A
Completed NCT03473561 - Study to Evaluate the Efficacy and Safety of Racecadotril in Children Aged 3 to 60 Months Suffering From Acute Diarrhea Phase 3