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Clinical Trial Summary

The primary objective of this study is to establish a human Campylobacter jejuni infection model with the following characteristics:

1. Safe application

1. Infectious period risk mitigated by close monitoring and prospectively applied early treatment criteria

2. Potential post-infectious sequelae risk mitigated by appropriate strain and host selection

2. Campylobacteriosis attack rate of at least 75%

Secondary objectives are to determine humoral, cell-mediated, and mucosal immune responses in the newly established human C. jejuni infection model and evaluate short-term (< 3 mo) protection upon repeat exposure to homologous C. jejuni strain and assess immune responses associated with protection.


Clinical Trial Description

n/a


Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00434798
Study type Interventional
Source University of Vermont
Contact
Status Active, not recruiting
Phase Phase 1
Start date February 2007
Completion date October 2008

See also
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Not yet recruiting NCT06432777 - Recurrent Campylobacter Bacteraemia in Immunocompromised Patients
Active, not recruiting NCT02040922 - Campylobacter Enteritis and Post-Infective Bowel Dysfunction (PI-BD): Role of Antibiotics and Microbiota N/A
Recruiting NCT01048112 - Campylobacter Jejuni Challenge Model Development: Assessment of Homologous Protection Phase 1
Recruiting NCT06425250 - Campylobacter Spp. Bone and Joint Infection: a Retrospective Cohort Study
Completed NCT04182490 - LMN-101 in a Campylobacter Human Challenge Model Phase 2
Completed NCT02884752 - Retrospective Study of Bone Infection Due to Campylobacter Spp N/A