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CampETEC Hyperimmune Bovine Colostrum (HBC) - Trial NCT06122870

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.

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NCT06122870
Phase 1
Not yet recruiting
biological
Trial Details
ClinicalTrials.gov โ€ข NCT06122870
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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

Study Focus

Healthy Volunteer

CampETEC HBC product

Interventional

biological

Sponsor & Location

Johns Hopkins Bloomberg School of Public Health

Timeline & Enrollment

Phase 1

Dec 01, 2023

Feb 01, 2025

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 person
Routine general health check-up of armed forces
Persons encountering health services in other circumstances
Persons encountering health services in other circumstances
Person encountering health services in unspecified circumstances

Data Source

ClinicalTrials.gov

NCT06122870

Non-Device Trial