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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if Travelan® can protect healthy adults from getting diarrhea when exposed to a harmful bacteria. Participants take Travelan® to see if it stops the bacteria from causing illness.

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 Travelan safe for humans?

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 as antibiotics and antidiarrheal agents, which are generally considered safe when used as directed. ^{1 2 3 4 5}

How does the drug Travelan differ from other treatments for traveler's diarrhea?

Travelan is unique because it is a non-antibiotic option that aims to prevent traveler's diarrhea by targeting the bacteria in the gut, unlike traditional treatments that often rely on antibiotics, which can lead to resistance and other side effects. ^{1 3 6 7 8}

Research Team

Mohamed Al-Ibrahim, MB,ChB,FACP

Principal Investigator

Pharmaron Clinical Pharmacology Center

Eligibility Criteria

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.

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

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

Timeline

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

References

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

Travelers' Diarrhea and Other Gastrointestinal Symptoms Among Boston-Area International Travelers. [2022]

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

Effect of adjunctive loperamide in combination with antibiotics on treatment outcomes in traveler's diarrhea: a systematic review and meta-analysis. [2022]

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

The role of location of food consumption in the prevention of travelers' diarrhea in Mexico. [2013]

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

Pharmacists' self-medication for the travelers' diarrhea. [2004]

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

Therapy of travelers' diarrhea with rifaximin on various continents. [2022]

6. France pubmed.ncbi.nlm.nih.gov

[Principles and management of the ambulatory treatment of traveller's diarrhea]. [2016]

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

Test-of-cure stool cultures for traveler's diarrhea. [2022]

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

Persistent diarrhea in travelers. [2019]