DiarrheaPhase 2NCT05933525
Clinical Study to Assess the Efficacy of Once-daily IMM-124E (Travelan®) in a Controlled Human Infection Model.
A Phase 2 study testing Travelan in people with Diarrhea and Travelers Diarrhea, run by Immuron Ltd. at 1 site in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled study to investigate a single daily dose of Travelan® protects healthy adult volunteers from moderate-to-severe diarrhea upon challenge with Enterotoxigenic Escherichia coli (ETEC) strain H10407. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea, Travelers Diarrhea, Infectious Diarrhea
- What is being tested?
- Travelan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2023to 30 Dec 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female between 18 and 50 years of age, inclusive at time of screening visit.
- General good health, without significant medical illness, abnormal vital signs or physical examination findings, or clinical laboratory abnormalities, as determined by the principal investigator (PI) in consultation with the Medical Monitor and Sponsor.
- Demonstrate comprehension of the protocol procedures, requirements, and CHIM this will be evaluated by completing a multiple choice comprehension assessment (passing grade > 70%) during screening and in the consenting process.
- Willing to participate, as evidenced by signing the informed consent document.
- Available for all planned follow-up visits.
- Negative serum pregnancy test at screening and negative serum and/or urine pregnancy test on the day of admittance to the inpatient unit for all female participants. All females must agree to use an efficacious hormonal or barrier method of birth control during the study. Efficacious methods of birth control include hormonal birth control methods (oral contraceptive pills, patches, vaginal rings, long-acting reversible contraception, surgical sterilization, condoms with spermicide, or abstinence from intercourse with a male partner. Female participants unable to bear children must have this documented (e.g., tubal ligation or hysterectomy).
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- A negative Covid-19 PCR test is required on the day of admission to the unit to comply with Pharmaron's Covid-19 policy (subjects reporting to admission for Cohort 1 who test positive for COVID-19 may rescreen for Cohort 2)
- Acceptable hematology and blood chemistry levels as assessed by the PI. i.e., Serum creatinine <1.3 mg/dL. AST, GGT, amylase, lipase, alkaline phosphatase not to exceed 1.5x upper limit of normal (ULN)
- Vital signs will be assessed in the supine position and must be within the following ranges:
- Oral body temperature between 35-37oC inclusive
- Systolic blood pressure between 90-140 mmHg inclusive
- Diastolic blood pressure between 55-90 mmHg inclusive
- Pulse rate between 45-90 bpm inclusive
Who cannot join
- Presence of a significant medical condition (e.g., psychiatric conditions such as significant anxiety, depression, or somatization disorder; gastrointestinal disease, such as peptic ulcer, symptoms or evidence of active gastritis/dyspepsia, gastroesophageal reflux disease, inflammatory bowel disease, or irritable bowel syndrome (as suggested by medical history or medical diagnosis); history of major gastrointestinal surgery; or laboratory abnormalities that in the opinion of the investigator preclude participation in the study. Significant medical conditions include HIV, active Hepatitis B or C infection, ongoing immunosuppression for any reason, autoimmune disease, any underlying cardiac, pulmonary, endocrine, or renal conditions, any gastrointestinal illness (chronic reflux, inflammatory bowel disease, ulcer), any diabetes mellitus, and other such illnesses that can put a volunteer at increased risk. Exclusionary laboratory abnormalities include any abnormality that is grade 2 or above, or any two grade 1 laboratory abnormalities.
- Immunosuppressive illness or evidence of IgA deficiency (serum IgA levels outside the normal range). This includes any disease that requires immunosuppressive medication such corticosteroids, monoclonal antibodies that target key aspects of the immune system (e.g. rituximab or TNF-blockers, or any autoimmune disease).
- Positive serology results for HIV, HBsAg, or HCV antibodies, and confirmatory tests if appropriate.
- Positive urine drug screen (positive for the presence of amphetamines, barbiturates, opiates, phencyclidine, cocaine, benzodiazepines, methadone, and propoxyphene at screening and at the discretion of the study physician, with the exception of stable persons with a diagnosis of ADHD that is well-controlled with a prescribed amphetamine.
- History of alcohol abuse in the past 3 months or drug abuse in the past year
- Significant abnormalities in screening laboratory hematology, serum chemistry or electrocardiogram, as determined by the PI or PI in consultation with the Medical Monitor and Sponsor. Significant ECG abnormalities include the following:
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- PR > 220 msec
- QRS complex > 120 msec
- QTcF > 450 msec (male) or >460 msec (female)
- Serum bilirubin exceeds upper limit of normal
- Use of any medication known to affect immune function (e.g., corticosteroids and others) within 30 days preceding receipt of the investigational products or planned to be used during the active study period. Any regular systemic corticosteroid will be exclusionary, while topical, intranasal, and inhaled steroids will be permitted.
- Nursing or lactating on the day of admittance to the inpatient unit.
- Inability to tolerate 150 ml of sodium bicarbonate buffer.
- Recent vaccination (including licensed vaccines) or receipt of an investigational product (within 30 days before challenge through 30 days following the challenge dose).
- History of diarrhea (> 3 unformed or liquid stools over a 24-hour period) in the 2 weeks prior to the planned inpatient phase.
- Fewer than 3 stools per week or more than 3 stools per day as the usual frequency, or loose or liquid stools other than on an occasional basis.
- Regular use of laxatives or any agent that increases gastric pH (regular defined as at least weekly).
- Use of proton pump inhibitors, H2 blockers, or antacids within 48 hours of dosing.
- A fever (≥38.0°C) in the 2 weeks prior to time of challenge.
- Use of antibiotics during the 30 days before bacterial dosing or receipt of more than 3 courses of antibiotics over the two months prior to dosing.
- Blood or plasma donation of one pint or more within 30 days preceding the receipt of the investigational products.
- Lactose intolerance or allergy to milk or milk products.
- Employment as a health care worker, food handler, childcare worker, or caregivers for elderly or immunocompromised individuals.
- Allergy to fluoroquinolones, trimethoprim-sulfamethoxazole, doxycycline, or ampicillin/penicillin (excluded if allergic to two of four).
- History of microbiologically confirmed ETEC infection in the last 3 years.
- Occupation involving handling of ETEC currently, or in the past 3 years.
- Symptoms consistent with travelers' diarrhea defined as >3 unformed or liquid stools over a 24 hour period concurrent with travel to countries where ETEC infection is endemic (most of the developing world) within 3 years prior to dosing, OR planned travel to endemic countries during the length of the study. ETEC endemic countries include all countries in Asia (except for Japan and South Korea) the Middle East, Africa, Mexico, Central and South America.
- Vaccination for or ingestion of ETEC, cholera, Shigella, or E. coli heat-labile toxin within 5 years prior to dosing.
- Any prior experimental infection with ETEC strain H10407, or prior experimental infection with other ETEC strains or other bacterial enteric pathogens (Salmonella, Shigella, and Campylobacter) within the past 5 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pharmaron Clinical Pharmacology Center
Baltimore, Maryland, 21201
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy of Once-daily Dosing of IMM-124E (Travelan®) in a Controlled Human Infection Model for Enterotoxigenic Escherichia Coli (ETEC)
This is a randomized, double-blind, placebo-controlled study to investigate a single daily dose of Travelan® protects healthy adult volunteers from moderate-to-severe diarrhea upon challenge with Enterotoxigenic Escherichia coli (ETEC) strain H10407.
Read the detailed description
Sixty subjects will be randomized to receive either the Travelan® product or a placebo followed by challenge with ETEC strain H10407. Subjects will receive Travelan® or placebo tablets as a single daily dose beginning 2 days prior to experimental challenge with ETEC strain H10407. Travelan®/placebo will be administered for a total of 7 days, or until antibiotic treatment has been initiated. Antibiotic treatment will be initiated if early antibiotic treatment criteria are met or 5 days after challenge.
Early antibiotic treatment will commence when any of the following criteria are met, and a physician determines it to be warranted:
- Severe diarrhea based on volume (800 g in 24 hours)
- Diarrhea of any severity AND 2 or more of the following symptoms: severe abdominal pain, severe abdominal cramps, severe nausea, severe headache, severe myalgias, severe arthralgia), any fever (≥ 38.0°C), or any vomiting
- Any fever ≥ 39.0°C
- Subjects who experience unexpectedly severe events such as symptomatic hypotension (disproportionate to volume loss), renal dysfunction, or altered mental state at the discretion of the investigators.
- A study physician determines that early treatment is warranted for other reasons.
The placebo is a commercially sourced high-protein milk product repackaged and masked to mirror the Travelan® product.
Upon admission to the inpatient unit, clinical monitoring will consist of daily medical assessments with adverse event (AE) determination, vital signs at least three times daily, examination and weighing of all stools and safety laboratory tests. Any subject passing a loose diarrheal (grade 3-5 stool) will be encouraged to start drinking oral fluids at a rate equal to 1.5 times their stool output (or at the same rate as their emesis output as applicable). Intravenous (iv) rehydration will be provided if pre-specified criteria are met.
All subjects will be treated with ciprofloxacin (500 mg by mouth twice daily for three days) or other antibiotic where applicable starting 5 days after ingesting the H10407 challenge inoculum unless early treatment criteria are met. Subjects will be discharged from the inpatient facility when clinical symptoms are resolved or resolving and two consecutive stool cultures (taken at least 12 hours apart) are negative for the ETEC challenge strain. Subjects may be discharged earlier than Day 8 if they meet criteria.
- Conditions
- Diarrhea, Travelers Diarrhea, Infectious Diarrhea
- Being tested
- Travelan, Placebo
- Keywords
- Enterotoxigenic E.coli, Travelers diarrhea, prophylactic, ETEC, IMM-124E, Travelan
- Medical subject headings
- Diarrhea, Dysentery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TravelanBiological
Also called IMM-124E
Travelan tablets (1200mg) administered orally once daily for 7 days
PlaceboOther
Also called ProMilk 85 milk powder
Placebo (1200mg) tablets administered orally once daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Travelan | Active comparator | IMM-124E (Travelan) is the investigational product. Travelan 1200mg will be taken orally once daily for 7 days. Receives: Biological: Travelan |
| Placebo | Placebo comparator | ProMilk 85 milk powder is the placebo. Placebo has been manufactured into tablets using the same manufacturing process as Travelan. The same dosing schedule of 1200mg will be taken orally once-daily for 7 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protective Efficacy of a Single Daily Dose of Travelan Against Moderate-to-severe Diarrhea Following Challenge With Enterotoxigenic E. Coli (ETEC) Strain H10407.
The number of subjects who encounter moderate to severe diarrhea (defined as ≥4 Grade 3-5 stools in any 24-hour period post-challenge or ≥401 grams of Grade 3-5 stools in the 5-day period post-challenge) will be recorded for the Travelan group and the placebo group.
All stool samples will be collected, weighed and graded.
Stool grading scale:
Grade 1 = Fully formed (normal) Grade 2 = Soft (normal) Grade 3 = Thick liquid (diarrheal) Grade 4 = Opaque watery (diarrheal) Grade 5 = Rice-water (diarrheal).
Diarrhea (Grade 3-5 stools) severity in a 24 hour period (1g = 1ml):
1-mild (2-3 loose/liquid stool totaling <400 g), 2-moderate (4 to 5 loose/liquid stools or >401 to 800 g), 3-severe (6 or more loose/liquid stools totaling >800 g).
Measured: Monitoring period - Days 1 to Day 5 post challenge
Secondary outcomes (5)
Number of Subjects With Severe Diarrhea Post ETEC Challenge
Severe diarrhea defined as 6 or more loose liquid stools in a 24 hour period totaling >800g. (1g = 1ml).
All stools will be collected, weighed (1g = 1ml) and graded.
Stool Grading Scale:
Grade 1 = Fully formed (normal) Grade 2 = Soft (normal) Grade 3 = Thick liquid (diarrheal) Grade 4 = Opaque watery (diarrheal) Grade 5 = Rice-water (diarrheal).
Diarrhea severity (Grade 3-5 stools) in a 24 hour period post-challenge (1g = 1ml):
1-mild (2-3 loose/liquid stool totaling <400 g), 2-moderate (4 to 5 loose/liquid stools or >401 to 800 g), 3-severe (6 or more loose/liquid stools totaling >800 g).
Measured: Monitoring period - Days 1 to Day 5 post challenge
Subjects With Diarrhea of Any Severity
The number of subjects who encounter diarrhea of any severity post challenge will be recorded for the Travelan group and the placebo group.
All stool samples will be collected, weighed and graded.
Stool grading scale:
Grade 1 = Fully formed (normal) Grade 2 = Soft (normal) Grade 3 = Thick liquid (diarrheal) Grade 4 = Opaque watery (diarrheal) Grade 5 = Rice-water (diarrheal).
Diarrhea (Grade 3-5 stools) severity in a 24 hour period (1g = 1ml):
1-mild (2-3 loose/liquid stool totaling <400 g), 2-moderate (4 to 5 loose/liquid stools or >401 to 800 g), 3-severe (6 or more loose/liquid stools totaling >800 g).
Measured: Monitoring period - Days 1 to Day 5 post challenge
Subjects Requiring Oral Rehydration Solution and/or Intravenous Fluids Post ETEC Challenge for the Travelan Group and the Placebo Group
Measurement of the number of subjects who require oral rehydration solution and/or intravenous fluids on one or more days post challenge.
Measured: Monitoring period - Days 1 to Day 5 post challenge
Subjects Requiring Early Antibiotic Treatment
Early antibiotic treatment commenced when any of the follow criteria were met and a physician determined it was warranted:
- Severe diarrhea (Grade 3-5 stools) based on volume (>800g in 24 hrs)
- Diarrhea of any severity AND 2 or more of the following symptoms classified as severe (CTCAE v5.0, Grade 3) abdominal pain, abdominal cramps, nausea, arthralgia, fever >38oC.
- Any fever >39oC
- Subjects who experienced unexpected severe events such as symptomatic hypotension disproportionate to volume loss, renal dysfunction or altered mental state at the discretion of the investigators
- A study physician determines that early treatment is warranted for other reasons
Measured: Monitoring period - Days 1 to Day 5 post challenge
Number of Participants With AEs Graded as Moderate-to-severe (Grade 2-4) for Diarrhea, Fever, Vomiting and Other Listed AEs as Assessed Using the CTCAE v5.0 Criteria for AEs.
All AEs will be recorded for the Travelan group and the placebo group using the following criteria (1-4):
- Diarrhea severity (Grade 3-5 stools) in a 24 hour period (1g = 1ml):1-mild (2-3 loose/liquid stool totaling <400 g), 2-moderate (4 to 5 loose/liquid stools or >401 to 800 g), 3-severe (6 or more loose/liquid stools totaling >800 g).
- Temperature maximum measured in a 24 hr period: no fever (<38.0°C), 1-mild (38.0-38.4°C), 2-moderate (38.5-38.9°C), 3-severe (>39.0°C); 4-Potentially life threatening (>40oC).
- Vomiting in a 24 hr period: 0-no episodes, 1-mild (1-2 episodes), 2-moderate (2-3 episodes), or 3-severe (>5 episodes).
- Nausea, abdominal discomfort and pain, abdominal cramps, headache, malaise or anorexia graded as follows: 0-Non-existent, 1 -mild (not interfering with routine activities), 2 -moderate (interfering but not precluding routine activities), 3 -severe (precluding routine activities), 4 - potentially life threatening (requires hospitalization)
Measured: Monitoring period - Days 1 to Day 5 post challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start29 May 2023
- Primary completion1 Jul 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 60 healthy volunteer participants will be randomized to receive Travelan investigational product or placebo. The study is a double-blind randomized study. All subjects will receive the challenge strain 2 days after dosing commences and monitored for diarrheal symptoms. At conclusion of the 7-day dosing and 5-days post challenge subjects will be given antibiotics to promote clearance of the challenge strain and allow subjects to return home.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immuron Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense, Naval Medical Research Center
- Responsible party
- Sponsor
- Investigators
- Mohamed Al-Ibrahim, MB,ChB,FACP, Principal investigator, Pharmaron Clinical Pharmacology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933525
- Sponsor's protocol ID
- IMM-124E-2002
- Other IDs
- MT21010.13
- Status last verified
- Sep 2025
- First submitted
- 26 May 2023
- Last updated
- 12 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy of Once-daily Dosing of IMM-124E (Travelan®) in a Controlled Human Infection Model for Enterotoxigenic Escherichia Coli (ETEC)
- ClinicalTrials.gov ID
- NCT05933525
- Acronym / sponsor ID
- IMM-124E-2002
- Conditions
- Diarrhea, Travelers Diarrhea, Infectious Diarrhea
- Keywords
- Enterotoxigenic E.coli, Travelers diarrhea, prophylactic, ETEC, IMM-124E, Travelan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Immuron Ltd.Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense, Naval Medical Research Center
- Study start
- 29 May 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 6 Jul 2023 (actual)
- Results
- Posted 12 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled study to investigate a single daily dose of Travelan® protects healthy adult volunteers from moderate-to-severe diarrhea upon challenge with Enterotoxigenic Escherichia coli (ETEC) strain H10407.
Detailed description
Sixty subjects will be randomized to receive either the Travelan® product or a placebo followed by challenge with ETEC strain H10407. Subjects will receive Travelan® or placebo tablets as a single daily dose beginning 2 days prior to experimental challenge with ETEC strain H10407. Travelan®/placebo will be administered for a total of 7 days, or until antibiotic treatment has been initiated. Antibiotic treatment will be initiated if early antibiotic treatment criteria are met or 5 days after challenge.
Early antibiotic treatment will commence when any of the following criteria are met, and a physician determines it to be warranted:
- Severe diarrhea based on volume (800 g in 24 hours)
- Diarrhea of any severity AND 2 or more of the following symptoms: severe abdominal pain, severe abdominal cramps, severe nausea, severe headache, severe myalgias, severe arthralgia), any fever (≥ 38.0°C), or any vomiting
- Any fever ≥ 39.0°C
- Subjects who experience unexpectedly severe events such as symptomatic hypotension (disproportionate to volume loss), renal dysfunction, or altered mental state at the discretion of the investigators.
- A study physician determines that early treatment is warranted for other reasons.
The placebo is a commercially sourced high-protein milk product repackaged and masked to mirror the Travelan® product.
Upon admission to the inpatient unit, clinical monitoring will consist of daily medical assessments with adverse event (AE) determination, vital signs at least three times daily, examination and weighing of all stools and safety laboratory tests. Any subject passing a loose diarrheal (grade 3-5 stool) will be encouraged to start drinking oral fluids at a rate equal to 1.5 times their stool output (or at the same rate as their emesis output as applicable). Intravenous (iv) rehydration will be provided if pre-specified criteria are met.
All subjects will be treated with ciprofloxacin (500 mg by mouth twice daily for three days) or other antibiotic where applicable starting 5 days after ingesting the H10407 challenge inoculum unless early treatment criteria are met. Subjects will be discharged from the inpatient facility when clinical symptoms are resolved or resolving and two consecutive stool cultures (taken at least 12 hours apart) are negative for the ETEC challenge strain. Subjects may be discharged earlier than Day 8 if they meet criteria.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 60 healthy volunteer participants will be randomized to receive Travelan investigational product or placebo. The study is a double-blind randomized study. All subjects will receive the challenge strain 2 days after dosing commences and monitored for diarrheal symptoms. At conclusion of the 7-day dosing and 5-days post challenge subjects will be given antibiotics to promote clearance of the challenge strain and allow subjects to return home.
| Arm | Type | Receives |
|---|---|---|
| Travelan | Active comparator | Biological: TravelanIMM-124E (Travelan) is the investigational product. Travelan 1200mg will be taken orally once daily for 7 days. |
| Placebo | Placebo comparator | Other: PlaceboProMilk 85 milk powder is the placebo. Placebo has been manufactured into tablets using the same manufacturing process as Travelan. The same dosing schedule of 1200mg will be taken orally once-daily for 7 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Male or female between 18 and 50 years of age, inclusive at time of screening visit.
- General good health, without significant medical illness, abnormal vital signs or physical examination findings, or clinical laboratory abnormalities, as determined by the principal investigator (PI) in consultation with the Medical Monitor and Sponsor.
- Demonstrate comprehension of the protocol procedures, requirements, and CHIM this will be evaluated by completing a multiple choice comprehension assessment (passing grade > 70%) during screening and in the consenting process.
- Willing to participate, as evidenced by signing the informed consent document.
- Available for all planned follow-up visits.
Key exclusion criteria (29 listed)
- Presence of a significant medical condition (e.g., psychiatric conditions such as significant anxiety, depression, or somatization disorder; gastrointestinal disease, such as peptic ulcer, symptoms or evidence of active gastritis/dyspepsia, gastroesophageal reflux disease, inflammatory bowel disease, or irritable bowel syndrome (as suggested by medical history or medical diagnosis); history of major gastrointestinal surgery; or laboratory abnormalities that in the opinion of the investigator preclude participation in the study. Significant medical conditions include HIV, active Hepatitis B or C infection, ongoing immunosuppression for any reason, autoimmune disease, any underlying cardiac, pulmonary, endocrine, or renal conditions, any gastrointestinal illness (chronic reflux, inflammatory bowel disease, ulcer), any diabetes mellitus, and other such illnesses that can put a volunteer at increased risk. Exclusionary laboratory abnormalities include any abnormality that is grade 2 or above, or any two grade 1 laboratory abnormalities.
- Immunosuppressive illness or evidence of IgA deficiency (serum IgA levels outside the normal range). This includes any disease that requires immunosuppressive medication such corticosteroids, monoclonal antibodies that target key aspects of the immune system (e.g. rituximab or TNF-blockers, or any autoimmune disease).
- Positive serology results for HIV, HBsAg, or HCV antibodies, and confirmatory tests if appropriate.
- Positive urine drug screen (positive for the presence of amphetamines, barbiturates, opiates, phencyclidine, cocaine, benzodiazepines, methadone, and propoxyphene at screening and at the discretion of the study physician, with the exception of stable persons with a diagnosis of ADHD that is well-controlled with a prescribed amphetamine.
- History of alcohol abuse in the past 3 months or drug abuse in the past year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TravelanAlso: IMM-124ETravelan tablets (1200mg) administered orally once daily for 7 days | Biological | Travelan |
| PlaceboAlso: ProMilk 85 milk powderPlacebo (1200mg) tablets administered orally once daily for 7 days | Other | Placebo |
Primary outcome
Protective Efficacy of a Single Daily Dose of Travelan Against Moderate-to-severe Diarrhea Following Challenge With Enterotoxigenic E. Coli (ETEC) Strain H10407.
Time frame: Monitoring period - Days 1 to Day 5 post challenge
The number of subjects who encounter moderate to severe diarrhea (defined as ≥4 Grade 3-5 stools in any 24-hour period post-challenge or ≥401 grams of Grade 3-5 stools in the 5-day period post-challenge) will be recorded for the Travelan group and the placebo group. All stool samples will be collected, weighed and graded. Stool grading scale: Grade 1 = Fully formed (normal) Grade 2 = Soft (normal) Grade 3 = Thick liquid (diarrheal) Grade 4 = Opaque watery (diarrheal) Grade 5 = Rice-water (diarrheal). Diarrhea (Grade 3-5 stools) severity in a 24 hour period (1g = 1ml): 1-mild (2-3 loose/liquid stool totaling <400 g), 2-moderate (4 to 5 loose/liquid stools or >401 to 800 g), 3-severe (6 or more loose/liquid stools totaling >800 g).
5 secondary outcomes
Number of Subjects With Severe Diarrhea Post ETEC Challenge
Time frame: Monitoring period - Days 1 to Day 5 post challenge
Subjects With Diarrhea of Any Severity
Time frame: Monitoring period - Days 1 to Day 5 post challenge
Subjects Requiring Oral Rehydration Solution and/or Intravenous Fluids Post ETEC Challenge for the Travelan Group and the Placebo Group
Time frame: Monitoring period - Days 1 to Day 5 post challenge
Subjects Requiring Early Antibiotic Treatment
Time frame: Monitoring period - Days 1 to Day 5 post challenge
Number of Participants With AEs Graded as Moderate-to-severe (Grade 2-4) for Diarrhea, Fever, Vomiting and Other Listed AEs as Assessed Using the CTCAE v5.0 Criteria for AEs.
Time frame: Monitoring period - Days 1 to Day 5 post challenge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Al-Ibrahim, MB,ChB,FACP principal investigator
Pharmaron Clinical Pharmacology Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Travelan in people with Diarrhea and Travelers Diarrhea, run by Immuron Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protective Efficacy of a Single Daily Dose of Travelan Against Moderate-to-severe Diarrhea Following Challenge With Enterotoxigenic E. Coli (ETEC) Strain H10407. (time frame: Monitoring period - Days 1 to Day 5 post challenge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.