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NCT06122870

CampETEC Hyperimmune Bovine Colostrum (HBC)

Double-blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of CampETEC Hyperimmune Bovine Colostrum (HBC) for the Prevention of Campylobacter-Mediated Diarrheal Diseases
Johns Hopkins Bloomberg School of Public Health·Phase 1·ClinicalTrials.gov·biologicalNot yet recruiting
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Study focus
Disease/Condition
Healthy Volunteer
Drug/Device/Intervention
CampETEC HBC product
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Johns Hopkins Bloomberg School of Public Health
Timeline & enrollment
Phase
Phase 1
Start date
Dec 01, 2023
End date
Feb 01, 2025
Enrollment
30 participants
Primary outcome

Incidence of Adverse Events,Number of participants with campylobacteriosis patterns

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.

ICD-10 classifications
Healthy person accompanying sick personRoutine general health check-up of armed forcesPersons encountering health services in other circumstancesPersons encountering health services in other circumstancesPerson encountering health services in unspecified circumstances
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06122870
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06122870 through Pure Global AI's free database. This Phase 1 trial is sponsored by Johns Hopkins Bloomberg School of Public Health and is currently Not yet recruiting. The study focuses on Healthy Volunteer. Target enrollment is 30 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.