At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Double-blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of CampETEC Hyperimmune Bovine Colostrum (HBC) for the Prevention of Campylobacter-Mediated Diarrheal Diseases
In Brief
A Phase 1 clinical trial evaluating CampETEC HBC product, ProMilk 85, and 1 other intervention for Healthy Volunteer. Completed, enrolled 27 participants across 1 site.
Detailed Summary
Gastrointestinal infections cause significant morbidity in the form of acute diarrheal illness in the United States (US) and among travelers to low- and middle-income countries (LMICs). One approach is to use passive protection (antibodies) to prevent infection. The purpose of this study are to assess the safety and tolerability of serum-derived bovine immunoglobulins in healthy adult subjects when orally administered and to estimate protective efficacy of those preparations against moderate-severe diarrhea upon challenge with Campylobacter C. jejuni strain CG8421.
Study Details
Timeline
Interventions
Immunoglobulin from bovine milk/colostrum and challenge strain
Placebo ProMilk 85
Challenge strain C. jejuni CG8421