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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
Awards & highlights

Study Summary

This trial tests if a product can protect people from moderate-to-severe diarrhea caused by a certain bacteria.

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.Check my eligibility
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).See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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.

Find a Location

Who is running the clinical trial?

Immuron Ltd.Lead Sponsor
5 Previous Clinical Trials
239 Total Patients Enrolled
United States Department of DefenseFED
861 Previous Clinical Trials
227,134 Total Patients Enrolled
Naval Medical Research CenterFED
33 Previous Clinical Trials
2,840 Total Patients Enrolled
10 Trials studying Diarrhea
1,056 Patients Enrolled for Diarrhea

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05933525 — Phase 2
Diarrhea Research Study Groups: Placebo, Travelan
Diarrhea Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05933525 — Phase 2
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05933525 — Phase 2

Frequently Asked Questions

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

Are there any eligibility criteria to qualify for participation in this trial?

"To be eligible, applicants should have the symptom of diarrhoea and fall between 18-50 years old. A total of 60 individuals are needed for this clinical trial."

Answered by AI

How many participants are being recruited for this clinical research?

"Affirmative. Clinicaltrials.gov data confirms that this clinical trial, first listed on May 29th 2023, is currently recruiting patients. Sixty subjects are required across a single site for the study's completion."

Answered by AI

Is there a maximum age restriction when applying for this research project?

"This clinical trial demands that participants fall within the age range of 18 to 50. Alternatively, there are 22 trials available for people under 18 and a further 50 studies ready for those older than 65 years old."

Answered by AI

Are participants of this clinical trial currently being accepted?

"Presently, this scientific trial is actively recruiting patients as per the records found online on clinicaltrials.gov. This study was first uploaded to the public domain on May 29th 2023 before receiving a recent update on July 5th 2023."

Answered by AI

Is taking Travelan a safe option for people seeking medical relief?

"Although there is no evidence yet that Travelan can be effective, existing data on its safety allows us to assign it a score of 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Clinical Study to Assess the Efficacy of IMM-124E (Travelan®) in a Controlled Human Infection Model
2023. "Clinical Study to Assess the Efficacy of IMM-124E (Travelan®) in a Controlled Human Infection Model". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05933525.
~0 spots leftby Apr 2024
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