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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a potential new way to prevent diarrhea using Hyperimmune Bovine Colostrum (HBC), a special kind of cow's milk rich in antibodies. Researchers aim to determine if this treatment is safe for healthy adults and if it can protect against diarrhea caused by Campylobacter bacteria. Participants should be in good health and have no recent history of digestive issues such as frequent diarrhea or lactose intolerance to qualify for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

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.

Is there any evidence suggesting that CampETEC Hyperimmune Bovine Colostrum is likely to be safe for humans?

Research is testing the safety of CampETEC Hyperimmune Bovine Colostrum (HBC) in healthy adults. The study aims to assess how well people tolerate it when taken orally.

As an early-stage study, it primarily checks for any harmful side effects. Specific data from these trials is not yet available, but early-phase trials typically focus on safety before evaluating effectiveness.

Although detailed safety data from this study is not yet available, similar treatments using bovine colostrum have been used safely for other conditions. This suggests it might be well-tolerated, but the study will provide more precise information. Participants in the trial will help researchers gather important data on any potential side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for preventing diarrhea, which often involve antibiotics or rehydration solutions, CampETEC Hyperimmune Bovine Colostrum (HBC) takes a unique approach. It harnesses the power of hyperimmune colostrum, a form of cow's first milk, which is rich in antibodies specifically targeting harmful bacteria like C. jejuni. Researchers are excited because this natural product could offer a more targeted and potentially less disruptive alternative to the gut microbiome compared to traditional antibiotics. Additionally, by directly targeting the pathogens responsible for diarrhea, CampETEC HBC might provide faster relief and prevention, reducing the incidence of diarrhea-related complications.

What evidence suggests that CampETEC Hyperimmune Bovine Colostrum might be an effective treatment for preventing diarrhea?

Research has shown that hyperimmune bovine colostrum (HBC), which participants in this trial may receive, can effectively reduce diarrhea caused by rotavirus and other gut infections. This special milk from cows contains antibodies that protect the body by fighting infections before they start. Previous patients demonstrated promising results in preventing moderate to severe diarrhea. While researchers are still studying this treatment for specific bacteria like Campylobacter in this trial, its success with similar infections is encouraging. These early findings suggest that HBC might offer valuable defense against certain stomach issues. ^{1 2 3 4 6}

Who Is on the Research Team?

Kawsar R Talaat, MD

Principal Investigator

Johns Hopkins Center for Immunization Research

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. ctv.veeva.com ctv.veeva.com/study/campetec-hyperimmune-bovine-colostrum-hbc

CampETEC Hyperimmune Bovine Colostrum (HBC) One modality that has shown considerable promise in diarrhea prevention is passive, oral administration of HBC, hyperimmune bovine colostrum. In ...

2. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-11-2023-94c57

Bovine Colostrum 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 ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/70/NCT06122870/Prot_SAP_000.pdf

Double-blind, Placebo-Controlled Trial Assessing the ... One modality that has shown considerable promise in diarrhea prevention is passive, oral administration of HBC, hyperimmune bovine colostrum.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06122870

CampETEC Hyperimmune Bovine Colostrum (HBC) This randomized, double-blinded, placebo-controlled study will explore if Hyperimmune bovine colostrum provides protection against oral challenges with ...

5. app.trialscreen.org app.trialscreen.org/trials/phase-1-campetec-hyperimmune-bovine-colostrum-hbc-trial-nct06122870

CampETEC Hyperimmune Bovine Colostrum (HBC) This study aims to assess the efficacy of hyperimmune bovine colostrum in preventing moderate to severe diarrhea caused by Campylobacter C.

6. synapse.patsnap.com synapse.patsnap.com/drug/82e9cd794f4d4904b933f72f47641458

CampETEC - Drug Targets, Indications, Patents Immuron has been advised by NMRC that the safety and protective efficacy of the product was tested in a controlled human infection-model clinical trial focusing ...