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CampETEC Hyperimmune Bovine Colostrum (HBC)

NCT06122870 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-08-22

Study results available
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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.

Conditions

  • Healthy Volunteer

Interventions

BIOLOGICAL

CampETEC HBC product

Immunoglobulin from bovine milk/colostrum and challenge strain

BIOLOGICAL

ProMilk 85

Placebo ProMilk 85

BIOLOGICAL

C. jejuni CG8421 Challenge strain

Challenge strain C. jejuni CG8421

Sponsors & Collaborators

  • Naval Medical Research Center

    collaborator FED

  • United States Department of Defense

    collaborator FED

  • The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc

    collaborator UNKNOWN

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Kawsar R Talaat, MD · Johns Hopkins Center for Immunization Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-04
Primary Completion
2024-06-04
Completion
2025-06-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06122870 on ClinicalTrials.gov