← Back to Search

Travelan® for Diarrhea Prevention in Travelers (P2 Trial)

N/A
Recruiting
Led By David R Tribble, MD, DrPH
Research Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18-70 years old, able to read and speak English fluently and provide informed consent
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3- and 6-months following return from travel/deployment
Awards & highlights

P2 Trial Summary

This trial will test if two dietary supplements can help maintain gut health during travel, compared to a placebo.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves dietary supplements designed for maintaining gut health rather than medication, specific side effects are not detailed but could include typical digestive discomforts such as bloating or gas.

P2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 70 years old, speak and read English fluently, and can give informed consent.

P2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3- and 6-months following return from travel/deployment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3- and 6-months following return from travel/deployment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of gut health deficiencies
Secondary outcome measures
Compliance and tolerability
Differences in gut health associated enteropathogen distribution
Incidence of functional gastrointestinal disorders and reactive arthritis

P2 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Travelan®Experimental Treatment1 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: PlaceboPlacebo Group1 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 Location

Who is running the clinical trial?

Henry M. Jackson Foundation for the Advancement of Military MedicineLead Sponsor
92 Previous Clinical Trials
92,023 Total Patients Enrolled
4 Trials studying Diarrhea
2,400 Patients Enrolled for Diarrhea
Uniformed Services University of the Health SciencesFED
116 Previous Clinical Trials
90,747 Total Patients Enrolled
4 Trials studying Diarrhea
1,013 Patients Enrolled for Diarrhea
US Defense Health ProgramUNKNOWN

Media Library

Travelan® Clinical Trial Eligibility Overview. Trial Name: NCT04605783 — N/A
Diarrhea Research Study Groups: Travelan®, Placebo
Diarrhea Clinical Trial 2023: Travelan® Highlights & Side Effects. Trial Name: NCT04605783 — N/A
Travelan® 2023 Treatment Timeline for Medical Study. Trial Name: NCT04605783 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for individuals to join this clinical research?

"The details about this trial listed on clinicaltrials.gov reveal that the recruitment process is no longer taking place; it was initially posted in April and last updated in December of 2021. However, there are 72 other studies presently open to new participants."

Answered by AI

What criteria must a participant meet to be considered for this research?

"To be eligible, participants must suffer from diarrhea and should lie within the ages of 18-70. The trial is currently recruiting approximately 1302 patients."

Answered by AI

Are there a variety of U.S.-based sites hosting this clinical experiment?

"This research endeavor is recruiting volunteers from Madigan Army Medical Center in Tacoma, Washington; Naval Medical Center Portsmouth in Portsmouth, Virginia; and Naval Medical Center San Diego in San Diego, California. Additionally, there are 6 other medical clinics participating as well."

Answered by AI

Does this clinical trial have any age restrictions for participation?

"In accordance with the stated participation conditions, individuals between 18 and 70 years of age can take part in this trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Trial to Evaluate Dietary Supplements to Maintain Gut Health During Travel
2022. "Trial to Evaluate Dietary Supplements to Maintain Gut Health During Travel". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04605783.
~100 spots leftby Jul 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top