CampETEC Hyperimmune Bovine Colostrum (HBC)

Healthy Volunteer Clinical Trial

Official title: Double-blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of CampETEC Hyperimmune Bovine Colostrum (HBC) for the Prevention of Campylobacter-Mediated Diarrheal Diseases

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

Controlled Human Infection ModelCampylobacter is a leading cause of foodborne disease in the US, is associated with 7.5 million disability adjusted life years globally and is a pathogen of concern in pediatric populations in LMICs and adult travelers to those same regions. Campylobacteriosis disproportionately affects poor and marginalized populations of the developing world and is particularly hazardous to the health and viability of infants in this region. The global diarrhea burden caused by Campylobacter spp. is estimated to include 88 million episodes in children aged ≤5 years, resulting in roughly 41,000 deaths. Among all age groups, the estimates of episodes and deaths are roughly 172 million and 75,000, respectively. In the US, Campylobacter causes more than 1.5 million illnesses each year mostly due to the handling and consumption of raw or undercooked poultry. For travelers, Campylobacter causes a severe form of Traveler's Diarrhea (TD), often associated with longer illness duration, increased number of unformed stools, and a high frequency of other symptoms (abdominal pain, nausea, vomiting, and fever) in comparison with other TD etiologies. In addition, Campylobacter infection is associated with several important sequelae, including Guillain-Barré syndrome (GBS), reactive arthritis, irritable bowel syndrome, and, to a lesser extent, inflammatory bowel disease. Until recently, campylobacteriosis has been viewed as a self-limiting illness that is ameliorated by antibiotic treatment; however, resistance of Campylobacter to antibiotics, particularly fluoroquinolones, has become a concern. Thus, alternative measures to control infection are needed. C. jejuni lacks virulence factors analogous to those of better-characterized pathogens. However, the C. jejuni Capsular polysaccharide (CPS) was recently identified and is now recognized as a major virulence factor and the focus of vaccine development efforts. A total of 47 C. jejuni capsule types have been described and through structure homology can be collapsed into 35 groups. Based on scant epidemiological data from developing countries, it appears that a limited number of C. jejuni capsule types are responsible for the majority of the disease.

One modality that has shown considerable promise in diarrhea prevention is passive, oral administration of HBC, hyperimmune bovine colostrum. In a number of clinical trials, HBC as well as bovine serum IgG (BSIgG), with specific activity against enteropathogens like Enterotoxigenic E. coli (ETEC), Shigella, and rotavirus, have shown to prevent diarrheal disease in Controlled Human Infection Models (CHIM). This study will establish the foundation for evaluating HBC products against Campylobacter.

This randomized, double-blinded, placebo- controlled study will explore if Hyperimmune bovine colostrum provides protection against oral challenges with Campylobacter in healthy adult participants. There will be an inpatient admission of approximately 30 subjects. Participants will be randomized to receive the investigational product (IP) or placebo three times daily following meals beginning 2 days prior to challenge. Each volunteer will be challenged with C.jeuni strain CG8421 on Day 1. The investigational product/placebo will be administered for a total of 7 days, or until antibiotic treatment has been administered. The investigators hypothesize that HBC will provide protection against C. jejuni strain CG8421 mediated moderate to severe diarrhea upon challenge. ;

Related Conditions & MeSH terms

• Healthy Volunteer

• NCT number: NCT06122870
• Study type: Interventional
• Source: Johns Hopkins Bloomberg School of Public Health
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: December 4, 2023
• Completion date: July 2025