Travelan® for Diarrhea Prevention in Travelers

(P2 Trial)

No longer recruiting at 7 trial locations

Overseen By Tahaniyat Lalani, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

Must not be taking: Antibiotics, Probiotics, Prebiotics, others

Disqualifiers: Bowel disorders, Gastrointestinal disease, Cancer, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Travelan®, a dietary supplement, to determine if it can maintain normal gut health during overseas travel. Participants will take either Travelan® or a placebo (a harmless pill with no active ingredients) for comparison. The trial targets individuals traveling for at least 10 days to areas where stomach issues are common, requiring them to provide a stool sample before starting. The goal is to discover if Travelan® can prevent travel-related digestive problems without serving as a medicine. As an unphased trial, this study allows participants to contribute to research that could improve travel health for many.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you cannot use antibiotics (except for certain malaria medications), investigational drugs, or other probiotics/prebiotics during the study. You also cannot use medications that interfere with gut function, like anti-diarrheals, during the study period.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Travelan® is generally safe and effective in preventing traveler's diarrhea. Studies have found that it can reduce the risk and severity of diarrhea caused by certain bacteria in up to 90% of people. Although specific safety details for Travelan® are not provided in the research, it is considered very safe, with no major side effects reported by users. Travelan® is also approved as a Natural Health Product in Canada, supporting its reputation as a safe choice for maintaining gut health while traveling. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for traveler's diarrhea focus on managing symptoms after they appear, often using antibiotics or rehydration therapies. However, Travelan® is unique because it aims to prevent diarrhea before it starts. This over-the-counter product is derived from hyperimmune bovine colostrum powder, which is rich in antibodies that target bacteria responsible for traveler's diarrhea. Researchers are excited about Travelan® because it offers a proactive approach, potentially protecting travelers throughout their journey, making it a convenient and innovative option compared to traditional treatments.

What evidence suggests that Travelan® might be an effective treatment for diarrhea prevention in travelers?

Studies have shown that Travelan®, one of the treatments tested in this trial, effectively prevents travel-related diarrhea. In one study, Travelan® provided 90.5% protection against diarrhea and reduced the number of loose stools by 91%. Another study found it was 66.7% effective in preventing severe diarrhea caused by ETEC, a common bacteria responsible for travelers' diarrhea. Overall, research suggests Travelan® is a strong option for maintaining gut health while traveling by significantly lowering the risk of diarrhea and related symptoms. Participants in this trial may receive Travelan® or a placebo to further evaluate its effectiveness. ^{2 6 7 8 9}

Who Is on the Research Team?

David R Tribble, MD, DrPH

Principal Investigator

Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 who are traveling to places with a high risk of gut health issues. They must speak English, give informed consent, and be able to follow the study's procedures including providing stool samples. People can't join if they've recently taken antibiotics (except for certain malaria drugs), have bowel disorders or chronic GI diseases, had recent diarrhea, plan to use other gut health treatments during the study, or have cancer or been on immunosuppressants.

Inclusion Criteria

Ability to provide a stool sample prior to start of prophylaxis

Willingness to comply with study procedures

I can attend a follow-up visit after traveling.

Exclusion Criteria

I will not use any experimental drugs or certain supplements during the study, except for yogurt.

I plan to use medication to prevent stomach issues during the study.

I haven't had cancer or used immunosuppressants (except topical steroids) in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemoprophylaxis

Participants receive Travelan® or placebo starting 2 days prior to arrival and maintained for a maximum duration of 20 days during travel or deployment

10-20 days

Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidence of functional gastrointestinal disorders and reactive arthritis

3-6 months

What Are the Treatments Tested in This Trial?

Interventions

• Bimuno®
• Florastor®
• Placebo
• Travelan®

Trial Overview The trial is testing Travelan®, a dietary supplement meant to maintain gut health during travel, against a placebo. Participants will be randomly assigned to one of these two groups without knowing which one they're in. The goal is to see if Travelan® helps keep their digestive system working normally while they're away from home.

How Is the Trial Designed?

Group I: Travelan® Experimental Treatment 1 Intervention

Product will be started 2 days prior to arrival in overseas destination and maintained for a maximum duration of 20 days (minimum of 10 days) during travel or deployment.

Group II: Placebo Placebo Group 1 Intervention

Placebo will be started 2 days prior to arrival in overseas destination and maintained for a maximum duration of 20 days (minimum of 10 days) during travel or deployment.

Travelan® is already approved in United States for the following indications:

Approved in United States as Travelan for:

• Maintenance of gut health during travel

Who Is Running the Clinical Trial?

Henry M. Jackson Foundation for the Advancement of Military Medicine

Lead Sponsor

Trials

103

Recruited

94,300+

Uniformed Services University of the Health Sciences

Collaborator

Trials

130

Recruited

91,100+

US Defense Health Program

Collaborator

Trials

1

Recruited

870+

Published Research Related to This Trial

In a study of 60 adult travelers, the use of sodium butyrate (SB) with short-chain fatty acids (SCFA) significantly reduced the occurrence of travelers' diarrhoea (TD) to 4.5% compared to 40% in the placebo group, indicating its efficacy in prevention.

The treatment also led to fewer daily stools and reduced gastrointestinal symptoms like pain and nausea, with no reported adverse effects, suggesting that SB and SCFA are safe and effective options for preventing TD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sodium butyrate and short chain fatty acids in prevention of travellers' diarrhoea: a randomized prospective study. Krokowicz, L., Kaczmarek, BF., Krokowicz, P., et al.[2015]

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]

Traveler's diarrhea can often be prevented by practicing safe food and water habits while traveling, and prophylactic medications are generally not recommended for prevention.

If traveler's diarrhea occurs, the main treatment is fluid replacement, with additional options like bismuth subsalicylate or anti-motility agents, and early use of antibiotics can effectively treat the condition and prevent complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traveler's diarrhea: methods of prevention and treatment. Opal, SM., Wiest, PM., Olds, GR.[2004]

Travellers' diarrhea affects about one-third of people traveling to tropical regions, typically presenting symptoms by the third day of travel, highlighting the need for effective prevention strategies.

Preventive measures primarily involve dietary precautions, while prophylactic medications should be reserved for high-risk individuals; treatment generally focuses on fluid replacement and non-antimicrobial drugs, unless special circumstances arise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Travellers' diarrhea. Gully, PR.[2021]

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. fidelity.com fidelity.com/news/article/default/202510310600PRIMZONEFULLFEED9566017

Immuron Announces Clinical Trial Update Travelan provided: 90.5% protection against diarrhea*; 91% reduction in number of loose/diarrheal stools*; 100% reduction in abdominal pain* ...

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

Bioactive Immune Components of Anti-Diarrheagenic ... A commercial HBC product, Travelan, is available for prevention of ETEC-induced diarrhea. Despite its demonstrated clinical efficacy, the ...

3. smallcaps.com.au smallcaps.com.au/article/immuron-travelan-study-results-digestive-health-protection-phase-3-trial

Immuron's Travelan study results show major leap in digestive ... Interim results showed a 36.4% protective efficacy against ETEC-induced moderate-to-severe diarrhea and a 66.7% protective efficacy against ...

4. firstwordpharma.com firstwordpharma.com/story/5834917

Immuron Announces Positive Results Support Travelan ... 66.7% protective efficacy against ETEC induced severe diarrhea was observed in the Travelan® group compared to the placebo group (secondary ...

5. immuron.com.au immuron.com.au/wp-content/uploads/2025/08/MHSRS-poster-1.pdf

Clinical Evaluation of Travelan® an Oral Prophylactic for ... ➢ Travelan® was 75% effective in preventing shigellosis in a non-human ... Travelan® for prevention of Travelers' diarrhea in the U.S.. These findings ...

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

Before traveling take Travelan to reduce risk of travellers ... In Canada Travelan® is a licensed Natural Health Product (NPN 80046016) and is specifically indicated to reduce the risk of Travelers Diarrhea.

7. 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 ...

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

Bioactivity and efficacy of a hyperimmune bovine colostrum ... Travelan® represents a novel natural, and efficacious product to prevent TD with an excellent safety profile, demonstrated biological activity ...

9. immuron.com.au immuron.com.au/wp-content/uploads/2025/08/Military-Health-System-Research-Symposium-2023_Abstract-1.pdf

1 Clinical Evaluation of Travelan® an Oral Prophylactic for ... Travelers' diarrhea (TD) is often acquired through ingestion of contaminated food and water. TD is predominantly bacterial, with diarrheagenic Escherichia coli, ...