What side effects are associated with this type of intervention?

Common treatments for diarrhea include antibiotics like ciprofloxacin and dietary supplements such as probiotics and passive immunoprophylaxis products like Travelan®. Antibiotics can cause side effects such as nausea, vomiting, abdominal pain, and allergic reactions. Probiotics are generally well-tolerated but may cause mild gastrointestinal symptoms like gas and bloating. Passive immunoprophylaxis products are designed to be safe, but potential side effects could include mild gastrointestinal discomfort or allergic reactions.

What prior FDA approvals exist?

The FDA has approved several treatments for diarrhea, including antibiotics, antidiarrheal agents, and probiotics. However, specific approvals for passive immunoprophylaxis, such as Travelan®, which provides pre-formed antibodies to maintain gut health, are less common. Travelan® is a dietary supplement aimed at maintaining gut health during travel by providing passive immunoprophylaxis. This approach is distinct from traditional treatments as it focuses on prevention rather than direct treatment of diarrhea symptoms.

What other types of research exist?

One promising novel alternative to Travelan® for maintaining gut health and treating diarrhea is larazotide acetate. This oral peptide modulates intestinal tight junctions and has shown efficacy in reducing symptoms in patients with celiac disease who experience inadvertent gluten exposure. Further studies are needed to confirm its safety and effectiveness for broader applications, including diarrhea management.

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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

Must not have

Planned use of any investigational or non-registered drug, antibiotic or other probiotics or prebiotics (outside of the study product) during the study period. This does not include consumption of yogurt products

Intended use of a GH disruption prophylactic (e.g. Pepto-Bismol, rifaximin) during the study period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3- and 6-months following return from travel/deployment

Awards & highlights

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old, speak and read English fluently, and can give informed consent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

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

Select...

I have had diarrhea (3+ loose stools a day) in the last 3 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3- and 6-months following return from travel/deployment

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of gut health deficiencies

Secondary study objectives

Compliance and tolerability

Differences in gut health associated enteropathogen distribution

Incidence of functional gastrointestinal disorders and reactive arthritis

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.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for diarrhea include antimotility agents like loperamide, which slow intestinal movement to reduce stool frequency, and antibiotics such as rifaximin, which target bacterial pathogens causing the condition. Passive immunoprophylaxis, like Travelan®, involves providing pre-formed antibodies that bind to and neutralize pathogens in the gut, preventing them from causing infection. This approach is particularly important for diarrhea patients as it offers a preventive measure, maintaining gut health and reducing the risk of infection during travel or in high-risk environments.

Randomised trial of single-dose ciprofloxacin for travellers' diarrhoea.Travellers' diarrhoea.Effectiveness of rifaximin in prevention of diarrhoea in individuals travelling to south and southeast Asia: a randomised, double-blind, placebo-controlled, phase 3 trial.