Travelan for Traveler's Diarrhea

Overseen By Joanne L Casey, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Immuron Ltd.

Must not be taking: Corticosteroids, Immunosuppressants, Antibiotics, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Travelan® can protect healthy adults from moderate-to-severe diarrhea caused by a specific type of bacteria often encountered while traveling. Participants will receive either Travelan® or a placebo (a pill with no active medication) to assess Travelan®'s effectiveness. The trial seeks healthy adults without significant medical conditions and recent stomach issues or specific infections. Participants should also not have recent travel plans to areas where this bacteria is common. As a Phase 2 trial, this research measures Travelan®'s effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial requires that you stop taking any medication known to affect immune function, like corticosteroids, within 30 days before the study and during the study. You also need to avoid using proton pump inhibitors, H2 blockers, or antacids within 48 hours of dosing.

Is there any evidence suggesting that Travelan is likely to be safe for humans?

Research has shown that Travelan has been used in Canada to help prevent traveler's diarrhea and minor stomach problems. While detailed safety information is not provided, its approval in Canada suggests it is considered safe for this purpose. Travelan boosts the body's defenses to help prevent diarrhea. Currently in a Phase 2 trial for a new use, early studies likely indicated it was well-tolerated without serious safety concerns. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for traveler's diarrhea?

Most treatments for traveler's diarrhea, like antibiotics or antimotility agents, focus on managing symptoms or tackling bacterial infections. But Travelan works differently by harnessing antibodies from cow colostrum to prevent harmful bacteria from sticking to the gut lining in the first place, potentially stopping the diarrhea before it starts. This proactive approach is exciting because it might mean fewer antibiotics are needed, reducing the risk of antibiotic resistance and side effects. Plus, being a dairy-derived supplement, it offers a natural alternative for those looking for preventative options.

What evidence suggests that Travelan might be an effective treatment for traveler's diarrhea?

Research has shown that Travelan®, one of the treatments under study in this trial, can help prevent travelers' diarrhea caused by E. coli. One study found that Travelan® provided up to 90% protection against this infection, significantly reducing the risk of illness while traveling. Travelan® works by using antibodies from cow's first milk to combat the bacteria. Overall, evidence suggests that Travelan® is a promising option for preventing travelers' diarrhea. ^{6 7 8 9 10}

Who Is on the Research Team?

Mohamed Al-Ibrahim, MB,ChB,FACP

Principal Investigator

Pharmaron Clinical Pharmacology Center

Are You a Good Fit for This Trial?

Healthy adults aged 18-50, with no significant medical issues or recent vaccinations. Participants must test negative for COVID-19 and agree to use effective birth control if applicable. Exclusions include abnormal lab results, certain medication use, health care workers, and those with a history of specific infections or gastrointestinal conditions.

Inclusion Criteria

Acceptable hematology and blood chemistry levels as assessed by the PI. i.e., Serum creatinine <1.3 mg/dL. AST, GGT, amylase, lipase, alkaline phosphatase not to exceed 1.5x upper limit of normal (ULN)

Willing to participate, as evidenced by signing the informed consent document

Available for all planned follow-up visits

Exclusion Criteria

I haven't had vaccines or taken anything for ETEC, cholera, Shigella, or E. coli toxin in the last 5 years.

I haven't had any vaccines or trial drugs in the last 30 days.

Nursing or lactating on the day of admittance to the inpatient unit

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-challenge Treatment

Participants receive Travelan® or placebo caplets starting 2 days prior to ETEC challenge

2 days

1 visit (inpatient admission)

Challenge and Monitoring

Participants are challenged with ETEC strain H10407 and monitored for symptoms and adverse events

8 days

Daily visits (inpatient)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Travelan

Trial Overview The study is testing Travelan® against a placebo in preventing moderate-to-severe diarrhea caused by ETEC bacteria. It's a randomized trial where participants don't know if they're getting the real treatment or a dummy pill (placebo).

How Is the Trial Designed?

Group I: Travelan Active Control 1 Intervention

IMM-124E (Travelan) is the investigational product. Travelan 1200mg will be taken orally for 7 days.

Group II: Placebo Placebo Group 1 Intervention

ProMilk 85 milk powder is the placebo. Placebo has been manufactured into tablets using the same manufacturing process as Travelan. 1200mg will be taken orally for 7 days.

Who Is Running the Clinical Trial?

Immuron Ltd.

Lead Sponsor

Trials

6

Recruited

300+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Naval Medical Research Center

Collaborator

Trials

34

Recruited

2,900+

Published Research Related to This Trial

A study of pharmacists and their spouses traveling to high-risk areas for travelers' diarrhea revealed that while most adhered to recommended practices, 22.8% still used antidiarrheal drugs prophylactically despite guidelines advising against this.

The study highlighted that nearly half of the participants used antidiarrheal agents for symptomatic relief, with most ingredients aligning with current recommendations, but some inappropriate practices were noted, such as using prophylactic agents without dietary restrictions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacists' self-medication for the travelers' diarrhea. Jinks, MJ., Baker, DE.[2004]

Traveller's Diarrhea (TD) affects 20-50% of travelers and is primarily caused by bacteria like ETEC, Salmonella, and Shigella, with prevention largely relying on good eating habits, although compliance is often poor.

While TD is usually self-limiting, treatment focuses on rehydration, and antibiotics like quinolones are recommended for severe cases, though their use is limited due to concerns about drug resistance and the benign nature of the illness in most travelers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Principles and management of the ambulatory treatment of traveller's diarrhea]. Castelli, F., Beltrame, A., Carosi, G.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10718440/

Bioactivity and efficacy of a hyperimmune bovine colostrum ... Clinically, Travelan® when taken orally thrice daily was shown to reduce both the incidence and severity of ETEC-induced diarrhea in controlled ...

2. travelan.com travelan.com/us/blog/2018/01/31/travelan-successful-us-department-defense-testing/

New study shows Travelan® fights Montezuma's Revenge in ... Clinical trials show Travelan® confers protection of up to 90% against infection with the major strain of E.coli that causes travelers' diarrhea ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1477893924000176

Investigating the influence of probiotics in preventing ... The results showed that the incidence of travelers' diarrhea in the probiotic groups ranged from 3.9% to 53.2%, while in the placebo groups, it ranged from 7.6% ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK459348/

Travelers Diarrhea - StatPearls - NCBI Bookshelf - NIH The outcomes in most patients with traveler's diarrhea are good. However, in severe cases, dehydration can occur requiring admission.

5. cdc.gov cdc.gov/yellow-book/hcp/preparing-international-travelers/travelers-diarrhea.html

Travelers' Diarrhea | Yellow Book Travelers' diarrhea (TD) is the most predictable travel-related illness. Attack rates range from 30% to 70% of travelers during a 2-week period.

6. travelan.com travelan.com/ca/faq/

Before traveling take Travelan to reduce risk of travellers ... Reduces the risk of Travelers Diarrhea; Reduces the risk of minor gastro-intestinal disorders; Antimicrobial. In Canada Travelan® is a licensed ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5583472/

Bioactive Immune Components of Anti-Diarrheagenic ... Travelan (lots 47058 and 17135), Product for the reduction of risk of traveler's diarrhea and symptoms of minor GI disorders. Commercially ...

8. withpower.com withpower.com/trial/phase-2-dysentery-4-2023-bf645

Travelan for Traveler's Diarrhea · Info for Participants The research articles provided do not contain specific safety data for Travelan. However, they discuss the use of other treatments for traveler's diarrhea, such ...

9. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/imm-124e-immuron-traveler-s-diarrhea-likelihood-of-approval/

IMM-124E by Immuron for Traveler's Diarrhea IMM-124E is under clinical development by Immuron and currently in Phase II for Traveler's Diarrhea. According to GlobalData, Phase II drugs ...

10. biospace.com biospace.com/press-releases/immuron-announces-travelan-clinical-trial-update

Immuron Announces Travelan® Clinical Trial Update Travelan® is an orally administered passive immunotherapy that prophylactically reduces the likelihood of contracting travelers' diarrhea, a ...