Travelan® for Diarrhea Prevention in Travelers

(P2 Trial)

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen by David R Tribble, MD, DrPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Trial Summary

What is the purpose of this trial?

This trial tests Travelan®, a dietary supplement, to see if it can help travelers and deployed military personnel maintain normal gut health. The supplement aims to prevent gut issues like diarrhea during travel or deployment.

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.

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

Travelan® is unique because it is a non-antibiotic option for preventing traveler's diarrhea, focusing on dietary precautions and immune support rather than using antimicrobial agents, which are often controversial due to resistance and side effects. ^{1 2 3 4 5}

Research Team

David R Tribble, MD, DrPH

Principal Investigator

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

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Bimuno® (Dietary Supplement)
• Florastor® (Dietary Supplement)
• Placebo ()
• Travelan® (Dietary Supplement)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Madigan Army Medical Center Tacoma, WA

New York Center for Travel and Tropical Medicine New York, NY

Naval Medical Center Portsmouth Portsmouth, VA

Tripler Army Medical Center Honolulu, HI

Who Is Running the Clinical Trial?

Henry M. Jackson Foundation for the Advancement of Military Medicine

Lead Sponsor

Trials

103

Patients Recruited

94,300+

Uniformed Services University of the Health Sciences

Collaborator

Trials

130

Patients Recruited

91,100+

US Defense Health Program

Collaborator

Trials

1

Patients Recruited

870+

Findings from Research

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]

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]

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]

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. Netherlands pubmed.ncbi.nlm.nih.gov

Sodium butyrate and short chain fatty acids in prevention of travellers' diarrhoea: a randomized prospective study. [2015]

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

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

3. Canada pubmed.ncbi.nlm.nih.gov

Travellers' diarrhea. [2021]

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

Traveler's diarrhea: methods of prevention and treatment. [2004]

5. France pubmed.ncbi.nlm.nih.gov

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