Bovine Colostrum for Preventing Diarrhea

Overseen By Barbara DeNearing, RN, BSN

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Johns Hopkins Bloomberg School of Public Health

Must not be taking: Corticosteroids, TNF blockers

Disqualifiers: HIV, Hepatitis B/C, Diabetes, others

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

27 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop using any medication known to affect immune function, such as regular systemic corticosteroids, within 30 days before starting the study. Additionally, you must not use proton pump inhibitors, H2 blockers, or antacids within 48 hours of dosing, and antibiotics should not be used during the 7 days before bacterial dosing.

What data supports the effectiveness of the treatment CampETEC Hyperimmune Bovine Colostrum (HBC) for preventing diarrhea?

Research shows that hyperimmune bovine colostrum (HBC) has been effective in reducing diarrhea caused by rotavirus and other gastrointestinal infections. It has been used successfully for treating infections like cryptosporidiosis and C. difficile, suggesting it may help prevent diarrhea by boosting the body's immune response. ^{1 2 3 4 5}

Is hyperimmune bovine colostrum safe for human use?

Hyperimmune bovine colostrum (HBC) has been used in various studies and clinical trials, showing a high-safety profile in humans. It has been tested for different conditions, including gastrointestinal infections and immune modulation, without significant safety concerns. ^{1 2 3 6 7}

How does the treatment CampETEC Hyperimmune Bovine Colostrum (HBC) differ from other treatments for preventing diarrhea?

CampETEC Hyperimmune Bovine Colostrum (HBC) is unique because it is derived from cows immunized to produce high levels of specific antibodies, offering a natural and targeted approach to prevent diarrhea caused by enterotoxigenic Escherichia coli (ETEC). Unlike antibiotics, HBC can help maintain normal gut flora and reduce antibiotic resistance, making it a novel alternative for gastrointestinal health. ^{1 2 5 6 7}

What is the purpose of this trial?

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.

Research Team

Kawsar R Talaat, MD

Principal Investigator

Johns Hopkins Center for Immunization Research

Eligibility Criteria

This trial is for healthy adults aged 18-50 who are in good health, can attend all follow-up visits, and understand the study's requirements. Women of childbearing age must not be pregnant and agree to use birth control during the study.

Inclusion Criteria

I am not pregnant and agree to use birth control or abstain during the study.

You should be in good overall health with no major medical issues or abnormal test results, as decided by the main doctor in charge of the study.

You need to pass a written test about the study's rules and procedures with a score of 70% or higher.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the investigational product or placebo three times daily following meals, starting 2 days prior to challenge and continuing for 7 days or until antibiotic treatment is administered.

7 days

Inpatient admission

Challenge

Participants are challenged with C. jejuni strain CG8421 on Day 1 to assess the protective efficacy of the investigational product.

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the incidence of adverse events.

28 days

Treatment Details

Interventions

• CampETEC Hyperimmune Bovine Colostrum (HBC)

Trial Overview The trial tests CampETEC HBC product and ProMilk 85 against a C. jejuni strain to see if they're safe and can prevent severe diarrhea by providing passive protection through antibodies.

Participant Groups

Group I: CampETEC HBC group Experimental Treatment 2 Interventions

CampETEC HBC (hyper immune bovine colostrum) and challenge strain C. jejuni CG8421

Group II: Placebo ProMilk 85 group Placebo Group 2 Interventions

ProMilk 85 (placebo) and challenge strain C.jejuni CG8421

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

Naval Medical Research Center

Collaborator

Trials

34

Recruited

2,900+

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

Collaborator

Trials

1

Recruited

30+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

References

1. Norway pubmed.ncbi.nlm.nih.gov

Hyperimmune cow colostrum reduces diarrhoea due to rotavirus: a double-blind, controlled clinical trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Hyperimmune bovine colostrum for treatment of GI infections: a review and update on Clostridium difficile. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Human and Bovine Colostrum for Prevention of Necrotizing Enterocolitis: A Meta-analysis. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Bovine Colostrum in the Treatment of Acute Diarrhea in Children: A Double-Blinded Randomized Controlled Trial. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Treatment with bovine hyperimmune colostrum of cryptosporidial diarrhea in AIDS patients. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Bioactive Immune Components of Anti-Diarrheagenic Enterotoxigenic Escherichia coli Hyperimmune Bovine Colostrum Products. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Augmented antiviral T cell immunity by oral administration of IMM-124E in preclinical models and a phase I/IIa clinical trial: A method for the prevention and treatment of COVID-19. [2022]