What side effects are associated with this type of intervention?

Passive immunization with bovine colostrum antibodies, such as Travelan®, is generally well-tolerated with few reported side effects. Common treatments for diarrhea, including probiotics and prebiotics, also have a good safety profile with minimal side effects. Probiotics may occasionally cause mild gastrointestinal symptoms like bloating and gas. Prebiotics are usually well-tolerated but can theoretically promote the growth of harmful bacteria in preterm infants. Overall, these treatments are considered safe for most individuals.

What prior FDA approvals exist?

The FDA has approved several treatments for diarrhea, including antimotility agents like loperamide (Imodium) and bismuth subsalicylate (Pepto-Bismol). For infectious diarrhea, antibiotics such as rifaximin (Xifaxan) are used. However, treatments similar to Travelan®, which involves passive immunization with bovine colostrum antibodies, are less common. Travelan® is unique in its approach of using antibodies derived from bovine colostrum to provide passive immunity against Enterotoxigenic Escherichia coli (ETEC), a common cause of traveler's diarrhea. This method aims to neutralize pathogens before they cause illness, differing from traditional treatments that primarily address symptoms or bacterial eradication.

What other types of research exist?

Promising novel alternatives to Travelan® for diarrhea patients include probiotics such as Lactobacillus reuteri, which has shown efficacy in reducing symptoms of gastrointestinal disorders, and new formulations of oral rehydration solutions that incorporate zinc and prebiotics to enhance gut health and recovery. Additionally, advancements in microbiome-based therapies, including fecal microbiota transplantation (FMT) and next-generation probiotics, are being explored for their potential to restore healthy gut flora and treat various forms of diarrhea.

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Travelan for Traveler's Diarrhea

Phase 2

Waitlist Available

Led By Mohamed Al-Ibrahim, MB,ChB,FACP

Research Sponsored by Immuron Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up monitoring on study day 3 or 48 hours post challenge

Summary

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.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include digestive discomfort or allergic reactions since Travelan® is designed to combat intestinal bacteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ monitoring on study day 3 or 48 hours post challenge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~monitoring on study day 3 or 48 hours post challenge

This trial's timeline: 3 weeks for screening, Varies for treatment, and monitoring on study day 3 or 48 hours post challenge for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To measure the protective efficacy of oral administration of Travelan compared to placebo against moderate-to-severe diarrhea following with E.coli (ETEC) challenge.

Secondary study objectives

Density of ETEC organisms in post-challenge stool samples at 48 hours post ETEC challenge for the Travelan group and the placebo group

ETEC disease severity score to measure objective signs and symptoms of malaise, abdominal cramps, headache, lightheadedness, vomiting, diarrhea, fever measured post ETEC challenge for the Travelan group and the placebo group.

Measurement of diarrheal output of the total amount of loose stool (grade 3-5) post ETEC challenge for the Travelan group and the placebo group

+8 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: TravelanActive Control1 Intervention

IMM-124E (Travelan) is the investigational product. Travelan 1200mg will be taken orally for 7 days.

Group II: PlaceboPlacebo Group1 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.

Do I qualify?Apply below to find out

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

Passive immunization, such as with Travelan®, involves administering pre-formed antibodies (from bovine colostrum) to neutralize pathogens like Enterotoxigenic Escherichia coli (ETEC) in the gut, preventing them from causing infection and subsequent diarrhea. This method provides immediate, short-term protection. Other common treatments for diarrhea include oral rehydration therapy (ORT), which replenishes lost fluids and electrolytes, and antimotility agents like loperamide, which slow intestinal movement to reduce stool frequency. Understanding these mechanisms helps patients and healthcare providers choose the most appropriate treatment based on the cause and severity of diarrhea, ensuring effective and timely relief.

Epidemiological model of diarrhoeal diseases and its application in prevention and control.Travellers' diarrhoea.