Travelers' DiarrheaNCT02498301
Trial Evaluating Chemoprophylaxis Against Travelers' Diarrhea - Prevent TD
A study testing Rifaximin in people with Travelers' Diarrhea and Functional Bowel Disorders, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 6 sites in 2 countries.
Trial summary
The purpose of this study is to develop evidence on the relative efficacy of 2 rifaximin chemoprophylaxis regimens for the prevention of Travelers' Diarrhea (TD) in a deployed setting. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Travelers' Diarrhea, Functional Bowel Disorders, Reactive Arthritis
- What is being tested?
- Rifaximin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 449 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 10 Nov 2015to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- An Institutional Review Board (IRB) / Ethics Committee (EC)-approved informed consent form is signed and dated.
- Subject is at least 18 years of age
- Subject's duration of prophylaxis will be least 2 weeks.
- Subject is capable of and willing to comply with all study procedures and available for the end of study visits and sample collection at COO (within 6 months from start of prophylaxis).
- Women: Non-nursing and negative urine/serum pregnancy test with understanding (through informed consent process) to avoid pregnancy while on study drug. Sole reliance on oral contraceptives (OCPs) for birth control will not be recommended (see section 6.3.2.1.) Should an individual have a documented surgical sterilization in her medical record, a pregnancy test will not be required. If a volunteer becomes pregnant during the study, the principal investigator will notify the study research monitor and the IRBs. The pregnancy outcome will be followed per IRB and other regulatory requirements for US and UK personnel.
- (For US Personnel Only). Have consented to participate in TravMil protocol.
Who cannot join
- Subject received any systemic or gastrointestinal antibiotic in the 7 days prior to enrollment (except anti-malarial prophylaxis agents).
- Subject has hypersensitivity or allergy to rifaximin or rifampicin.
- Subject has acute diarrhea within 7 days prior to enrollment
- Subject has a concomitant disease or condition that could interfere with, or for which treatment could interfere with, the conduct of the study, or could in the opinion of the investigator increase the risk of AEs during the subject's participation in the study
- Subject is currently taking or plans to take during deployment at least one of the following medications: theophylline or warfarin (Coumadin).
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Tripler Army Medical Center/Schofield Barracks
Honolulu, Hawaii, 96786
Naval Hospital Camp Lejeune
Marine Corps Base Camp Lejeune, North Carolina, 28547
San Antonio Military Medical Center
San Antonio, Texas, 78234
Naval Medical Center San Diego
San Diego, California, 92134
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Clinical Trial Evaluating Two Dose Regimens of Rifaximin (550 mg Daily or 550 mg Twice Daily) for Chemoprophylaxis Against Travelers' Diarrhea (TD) Among Active Duty Deployed U.S. and British Military Personnel
The purpose of this study is to develop evidence on the relative efficacy of 2 rifaximin chemoprophylaxis regimens for the prevention of Travelers' Diarrhea (TD) in a deployed setting. An additional purpose is to explore the effect of chemoprophylaxis on microbial flora and antimicrobial resistance, and obtain parameter estimates to inform a cost-effectiveness model of chemoprophylaxis in prevention of TD. Information from this study will be used to develop management guidelines for the prevention of TD among deployed (United States (US) and United Kingdom (UK) military personnel.
The study will be a multi-site, randomized, placebo-controlled, double-blind, clinical trial among deployed military personnel. The study will test 2 TD chemoprophylaxis regimens (once daily versus twice daily) of the same antibiotic, rifaximin, compared to a placebo.
For the proposed chemoprophylaxis study described herein, cohorts of military personnel (US and UK) deploying/traveling overseas will be recruited prior to travel to participate and will undergo enrollment procedures as outlined in study appendices. Subjects who are eligible and agree to participate will be randomized to receive one of 3 regimens: (1) rifaximin 550 mg daily; (2) rifaximin 550 mg twice a day; or (3) placebo, to be taken while deployed. Chemoprophylaxis will be maintained for duration of travel or a predetermined period of up to 6 weeks and at least 2 weeks, which may include a period of up to 5 days of use after return to COO for deployments less than 6 weeks in duration. Clinical and laboratory data will be obtained before, during if available and after deployment/chemoprophylaxis.
Read the detailed description
The primary efficacy outcome will be assessed by review of the symptom memory aid (TravMil diary). Subjects will follow a symptom memory aid from the onset of a disease episode and record relevant symptomatology (date/time and number of diarrheal episodes, associated symptoms such as fever, vomiting, nausea, bloody stools and cramps, severity of symptoms, functional activity). Use of antibiotics and/or Imodium (loperamide) for each episode will also be recorded). An additional memory aid to capture occurrence of solicited adverse events, use of new prescription medications, as well as adherence to study medication regimen will be utilized by subjects during deployment and returned (or re-created with study personnel if lost or incomplete) at follow-up Memory aid data will be actively sought from all subjects via required in-person follow-up.
Secondary efficacy outcomes will also largely be derived from the self-report of subjects via use of the memory aid data. Secondary safety evaluation will be performed at the end of study visit based on history obtained from the subject regarding medical treatment requiring events while deployed.
Individuals will be enrolled prior to travel/deployment. At the time of enrollment they will undergo eligibility criteria review, informed consent process, baseline assessment (demographics, medical history, others), sample collection (blood and stool), and blinded randomization into a study arm.
Episodes of diarrhea are expected to occur while on study drug. Subjects will be instructed and expected to seek care for these episodes from medical assets available to them at COD.
Subjects will be instructed to discontinue study drug if they develop diarrhea and are given antibiotic therapy. It is not expected that study drug will impact the choice or effectiveness of antibiotics used to treat travelers' diarrhea. Some subjects will be eligible to restart (only once restart) study drug once they are cured of a travelers' diarrhea episode. See US and UK addenda for details.
The end of prophylaxis is defined as the +/- 96hr period from cessation of prophylaxis due to (A) the subject completing maximal period of prophylaxis but remains deployed, or (B) being re-deployed and returns to mainland/COO. During this end of prophylaxis period, subjects may be seen by study personnel and perform an end of prophylaxis visit.
The post-deployment period is defined as the return to COO through 8 weeks from return. A post-deployment visit, in the COO will be planned for all subjects enrolled in the study and will occur as soon as it can be scheduled.
All subjects will be asked to complete a baseline questionnaire on day of enrollment and complete web-based surveys during the follow-up period. Subjects will be emailed the survey link at 3 and 6 months post-return to COO. The survey will assess for several types of functional bowel disorders and symptoms of ReA using standardized questions and definitions and questions and will use disease activity scales to assess impact on daily life.
A sample of blood will be collected up to 2 times as part of participation in this study. The samples will be collected, processed and stored until transported at a later date to central lab for testing of acute and convalescent titers directed against bacterial and viral enteropathogens. Samples will also be used for biomarker evaluation and support of exploratory objectives.
Stool samples will be used for exploratory microbiological analyses to assess etiology of diarrhea by pathogen, antibiotic susceptibility of enteropathogens, and evaluation of impact of rifaximin on the microbiome. Serum will be utilized to attempt to determine seroconversion status for pathogens not identified during stool analysis.
- Being tested
- Rifaximin, Placebo
- Keywords
- travelers' diarrhea, military, enteric illness, gastrointestinal
- Medical subject headings
- Arthritis, Reactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
Also called Xifaxan
Rifaximin will be provided to subjects either daily with placebo, or twice daily depending on which of the two experimental arms they are randomized to
PlaceboDrug
Placebo will be administered twice daily or once daily with rifaximin depending on which experimental arm they are randomized to
| Study group | Role | What they receive |
|---|---|---|
| Rifaximin 550 mg once/day | Experimental | rifaximin, 550 mg, once daily, by mouth Receives: Drug: Rifaximin |
| Rifaximin 550 mg twice/day | Experimental | rifaximin, 550 mg, twice daily, by mouth Receives: Drug: Rifaximin; Drug: Placebo |
| Placebo | Placebo comparator | Placebo pills, twice daily, by mouth Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - Risk of travelers diarrhea during chemoprophylaxis as measured by self-report via use of a memory aid
Measured: 24hr
Secondary outcomes (2)
Efficacy as determined by use of a symptom memory aid.
Proportion of subjects in each treatment group with TD, with mild diarrhea, with TD associated with isolation of a pathogen and pathogen type, total diarrhea days, work days and performance loss due to diarrhea, comparison of incidence of TD
Measured: For a duration of prophylaxis which will be on average 3-4 weeks or a maximum of 6 weeks
Solicited adverse events as collected from the subject and using a memory aid
Solicited adverse events will be collected by use of a memory aid which will be reviewed at the last clinic visit, on average within 4 months from study enrollment.
Measured: For the duration of prophylaxis which will be on average 3-4 weeks or a maximum of 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study start10 Nov 2015
- Primary completionJul 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Travelers' 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Naval Medical Research Center, Ministry of Defence, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Ramiro Gutierrez, MD, Principal investigator, Naval Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498301
- Sponsor's protocol ID
- IDCRP-080
- Status last verified
- Nov 2021
- First submitted
- 6 Jul 2015
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Clinical Trial Evaluating Two Dose Regimens of Rifaximin (550 mg Daily or 550 mg Twice Daily) for Chemoprophylaxis Against Travelers' Diarrhea (TD) Among Active Duty Deployed U.S. and British Military Personnel
- ClinicalTrials.gov ID
- NCT02498301
- Acronym / sponsor ID
- IDCRP-080
- Keywords
- travelers' diarrhea, military, enteric illness, gastrointestinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- Naval Medical Research Center, Ministry of Defence, United Kingdom
- Study start
- 10 Nov 2015 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 15 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop evidence on the relative efficacy of 2 rifaximin chemoprophylaxis regimens for the prevention of Travelers' Diarrhea (TD) in a deployed setting. An additional purpose is to explore the effect of chemoprophylaxis on microbial flora and antimicrobial resistance, and obtain parameter estimates to inform a cost-effectiveness model of chemoprophylaxis in prevention of TD. Information from this study will be used to develop management guidelines for the prevention of TD among deployed (United States (US) and United Kingdom (UK) military personnel.
The study will be a multi-site, randomized, placebo-controlled, double-blind, clinical trial among deployed military personnel. The study will test 2 TD chemoprophylaxis regimens (once daily versus twice daily) of the same antibiotic, rifaximin, compared to a placebo.
For the proposed chemoprophylaxis study described herein, cohorts of military personnel (US and UK) deploying/traveling overseas will be recruited prior to travel to participate and will undergo enrollment procedures as outlined in study appendices. Subjects who are eligible and agree to participate will be randomized to receive one of 3 regimens: (1) rifaximin 550 mg daily; (2) rifaximin 550 mg twice a day; or (3) placebo, to be taken while deployed. Chemoprophylaxis will be maintained for duration of travel or a predetermined period of up to 6 weeks and at least 2 weeks, which may include a period of up to 5 days of use after return to COO for deployments less than 6 weeks in duration. Clinical and laboratory data will be obtained before, during if available and after deployment/chemoprophylaxis.
Detailed description
The primary efficacy outcome will be assessed by review of the symptom memory aid (TravMil diary). Subjects will follow a symptom memory aid from the onset of a disease episode and record relevant symptomatology (date/time and number of diarrheal episodes, associated symptoms such as fever, vomiting, nausea, bloody stools and cramps, severity of symptoms, functional activity). Use of antibiotics and/or Imodium (loperamide) for each episode will also be recorded). An additional memory aid to capture occurrence of solicited adverse events, use of new prescription medications, as well as adherence to study medication regimen will be utilized by subjects during deployment and returned (or re-created with study personnel if lost or incomplete) at follow-up Memory aid data will be actively sought from all subjects via required in-person follow-up.
Secondary efficacy outcomes will also largely be derived from the self-report of subjects via use of the memory aid data. Secondary safety evaluation will be performed at the end of study visit based on history obtained from the subject regarding medical treatment requiring events while deployed.
Individuals will be enrolled prior to travel/deployment. At the time of enrollment they will undergo eligibility criteria review, informed consent process, baseline assessment (demographics, medical history, others), sample collection (blood and stool), and blinded randomization into a study arm.
Episodes of diarrhea are expected to occur while on study drug. Subjects will be instructed and expected to seek care for these episodes from medical assets available to them at COD.
Subjects will be instructed to discontinue study drug if they develop diarrhea and are given antibiotic therapy. It is not expected that study drug will impact the choice or effectiveness of antibiotics used to treat travelers' diarrhea. Some subjects will be eligible to restart (only once restart) study drug once they are cured of a travelers' diarrhea episode. See US and UK addenda for details.
The end of prophylaxis is defined as the +/- 96hr period from cessation of prophylaxis due to (A) the subject completing maximal period of prophylaxis but remains deployed, or (B) being re-deployed and returns to mainland/COO. During this end of prophylaxis period, subjects may be seen by study personnel and perform an end of prophylaxis visit.
The post-deployment period is defined as the return to COO through 8 weeks from return. A post-deployment visit, in the COO will be planned for all subjects enrolled in the study and will occur as soon as it can be scheduled.
All subjects will be asked to complete a baseline questionnaire on day of enrollment and complete web-based surveys during the follow-up period. Subjects will be emailed the survey link at 3 and 6 months post-return to COO. The survey will assess for several types of functional bowel disorders and symptoms of ReA using standardized questions and definitions and questions and will use disease activity scales to assess impact on daily life.
A sample of blood will be collected up to 2 times as part of participation in this study. The samples will be collected, processed and stored until transported at a later date to central lab for testing of acute and convalescent titers directed against bacterial and viral enteropathogens. Samples will also be used for biomarker evaluation and support of exploratory objectives.
Stool samples will be used for exploratory microbiological analyses to assess etiology of diarrhea by pathogen, antibiotic susceptibility of enteropathogens, and evaluation of impact of rifaximin on the microbiome. Serum will be utilized to attempt to determine seroconversion status for pathogens not identified during stool analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rifaximin 550 mg once/day | Experimental | Drug: Rifaximinrifaximin, 550 mg, once daily, by mouth |
| Rifaximin 550 mg twice/day | Experimental | Drug: Rifaximin, Drug: Placeborifaximin, 550 mg, twice daily, by mouth |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo pills, twice daily, by mouth |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- An Institutional Review Board (IRB) / Ethics Committee (EC)-approved informed consent form is signed and dated.
- Subject is at least 18 years of age
- Subject's duration of prophylaxis will be least 2 weeks.
- Subject is capable of and willing to comply with all study procedures and available for the end of study visits and sample collection at COO (within 6 months from start of prophylaxis).
- Women: Non-nursing and negative urine/serum pregnancy test with understanding (through informed consent process) to avoid pregnancy while on study drug. Sole reliance on oral contraceptives (OCPs) for birth control will not be recommended (see section 6.3.2.1.) Should an individual have a documented surgical sterilization in her medical record, a pregnancy test will not be required. If a volunteer becomes pregnant during the study, the principal investigator will notify the study research monitor and the IRBs. The pregnancy outcome will be followed per IRB and other regulatory requirements for US and UK personnel.
Key exclusion criteria (5 listed)
- Subject received any systemic or gastrointestinal antibiotic in the 7 days prior to enrollment (except anti-malarial prophylaxis agents).
- Subject has hypersensitivity or allergy to rifaximin or rifampicin.
- Subject has acute diarrhea within 7 days prior to enrollment
- Subject has a concomitant disease or condition that could interfere with, or for which treatment could interfere with, the conduct of the study, or could in the opinion of the investigator increase the risk of AEs during the subject's participation in the study
- Subject is currently taking or plans to take during deployment at least one of the following medications: theophylline or warfarin (Coumadin).
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 |
|---|---|---|
| RifaximinAlso: XifaxanRifaximin will be provided to subjects either daily with placebo, or twice daily depending on which of the two experimental arms they are randomized to | Drug | Rifaximin 550 mg once/day, Rifaximin 550 mg twice/day |
| PlaceboPlacebo will be administered twice daily or once daily with rifaximin depending on which experimental arm they are randomized to | Drug | Placebo, Rifaximin 550 mg twice/day |
Primary outcome
Efficacy - Risk of travelers diarrhea during chemoprophylaxis as measured by self-report via use of a memory aid
Time frame: 24hr
2 secondary outcomes
Efficacy as determined by use of a symptom memory aid.
Time frame: For a duration of prophylaxis which will be on average 3-4 weeks or a maximum of 6 weeks
Solicited adverse events as collected from the subject and using a memory aid
Time frame: For the duration of prophylaxis which will be on average 3-4 weeks or a maximum of 6 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
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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.
Ramiro Gutierrez, MD principal investigator
Naval Medical Research Center
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rifaximin in people with Travelers' Diarrhea and Functional Bowel Disorders, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 6 sites in 2 countries.
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 6 inclusion and 5 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 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Kenya. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy - Risk of travelers diarrhea during chemoprophylaxis as measured by self-report via use of a memory aid (time frame: 24hr). 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 15 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.