DiarrheaPhase 2NCT00098384
Rifaximin Versus Placebo in the Prevention of Travelers' Diarrhea
A Phase 2 study testing rifaximin in people with Diarrhea, run by DuPont, Hurbert L., MD at 1 site in Mexico.
Trial summary
The purpose of this study is to evaluate the effectiveness of poorly absorbed rifaximin in the prevention of travelers' diarrhea among U.S. college students in Mexico for five weeks. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diarrhea
- What is being tested?
- rifaximin
- How many people
- 220 participants
- Where
- 1 siteMexico
- Study dates
- Jun 2003to Sep 2003
- Phase
- Phase 2
- 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 Investigational Review Board approved, written informed consent is appropriately witnessed, signed and dated prior to any study-related activities
- Male or female subjects 18 years of age or older
- Able to read and understand English
- Enrolled and started on prophylaxis within 72 hours of arrival in Mexico
- If the subject is female, only women with non-childbearing potential or those who are not pregnant will be eligible. Urine pregnancy tests will be performed on those women who question their pregnancy status. Women on the study are required to employ a reliable method of contraception while taking medication. Forms of acceptable contraception include:
- Double barrier method of contraception.
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- Oral birth control pills for at least two cycles before enrollment and continuing during therapy - subjects will be told they should use a barrier contraception method during the study as well.
- Norplant inserted at least one month before enrollment.
- An intrauterine device inserted by a qualified clinician.
- Medroxyprogesterone acetate for a minimum of one month before study and administered for one month following study completion.
- An approved birth control patch for at least two cycles before enrollment and continuing during therapy. OR
- Complete abstinence from intercourse for the two weeks of medication.
Who cannot join
- Acute diarrhea (criteria for travelers' diarrhea above) within the past week
- Diarrhea developing within 24 hours of study enrollment
- In Mexico for more than 72 hours
- Receipt of one of the following classes of drugs: fluoroquinolone (any drug in class), macrolide or azalide or trimethoprim-sulfamethoxazole within the past week or during the three week study
- Receipt of other medication to decrease the occurrence of diarrhea (e.g. bismuth subsalicylate or lactobacillus preparations)
- For females, pregnancy or breast feeding during the three week study
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- Receipt of antidiarrheal medication (loperamide, bismuth subsalicylate, kaopectate) within 24 hours of enrollment
- Hypersensitivity to rifaximin
- Unstable medical condition including chronic renal failure and insulin dependent diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Single Center, Comparative Dose Ranging Study of Rifaximin Vs. Placebo in the Prevention of Travelers' Diarrhea Due to Enteropathogenic Bacteria
The purpose of this study is to evaluate the effectiveness of poorly absorbed rifaximin in the prevention of travelers' diarrhea among U.S. college students in Mexico for five weeks.
Read the detailed description
This is an investigator-initiated proposal wherein 220 male and female subjects >17 years of age from industrialized regions were randomized to receive a poorly absorbed antibiotic, rifaximin, in one of three doses at mealtime (when they are exposed to diarrhea-causing bacteria), 200 mg once a day, 200 mg twice a day or 200 mg three times a day versus a placebo starting on arrival (within the first 72 hours) to Mexico and continuing for two weeks with diaries of symptoms recorded for three weeks. Adverse events in the subjects were followed for five weeks. If mild diarrhea (1 or 2 unformed stools/24 hours plus an enteric symptom) or diarrheal illness (>2 unformed stools/24 hours plus an enteric symptom) developed, subjects provided a stool sample to determine cause of illness. Forty subjects provided stool samples after 7 days and 14 days treatment to see if their intestinal bacterial flora had developed resistance to rifaximin and to see the level of drug achieved. Stool samples from these forty subjects were studied for enteric pathogens to look for asymptomatic infection during the period of prophylaxis. The stool samples collected were initially processed in our enteric laboratories in Guadalajara, Mexico. Specialized tests such as studies of toxigenicity for enterotoxigenic E. coli and enteroadherence for enteroaggregative E. coli were done in Houston.
- Conditions
- Diarrhea
- Being tested
- rifaximin
- Keywords
- Travelers' diarrhea, rifaximin, prophylaxis, enterotoxigenic E. coli
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rifaximinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of diarrhea, defined as passage of >2 unformed stools/24 hr plus one or more signs or symptoms of enteric infection
Secondary outcomes (3)
Occurrence of mild diarrhea (1 or 2 unformed stools/24 hr plus a sign or symptom)
Treatment failure (not well in five days)
Occurrence of moderate to severe abdominal pain/cramps or intestinal gas related symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2004 (estimated)
- Study startJun 2003
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- Enrolment
- 220 participants
Sponsor and investigators
- Lead sponsor
- DuPont, Hurbert L., MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00098384
- Sponsor's protocol ID
- PR 03
- Status last verified
- Dec 2004
- First submitted
- 7 Dec 2004
- Last updated
- 9 May 2006
- Results posted
- No
Publications
DuPont HL, Jiang ZD, Ericsson CD, Adachi JA, Mathewson JJ, DuPont MW, Palazzini E, Riopel LM, Ashley D, Martinez-Sandoval F. Rifaximin versus ciprofloxacin for the treatment of traveler's diarrhea: a randomized, double-blind clinical trial. Clin Infect Dis. 2001 Dec 1;33(11):1807-15. doi: 10.1086/323814. Epub 2001 Oct 23.
PubMed 11692292DuPont HL, Ericsson CD. Prevention and treatment of traveler's diarrhea. N Engl J Med. 1993 Jun 24;328(25):1821-7. doi: 10.1056/NEJM199306243282507. No abstract available.
PubMed 8502272DuPont HL, Jiang ZD, Okhuysen PC, Ericsson CD, de la Cabada FJ, Ke S, DuPont MW, Martinez-Sandoval F. A randomized, double-blind, placebo-controlled trial of rifaximin to prevent travelers' diarrhea. Ann Intern Med. 2005 May 17;142(10):805-12. doi: 10.7326/0003-4819-142-10-200505170-00005.
PubMed 15897530
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Single Center, Comparative Dose Ranging Study of Rifaximin Vs. Placebo in the Prevention of Travelers' Diarrhea Due to Enteropathogenic Bacteria
- ClinicalTrials.gov ID
- NCT00098384
- Acronym / sponsor ID
- PR 03
- Conditions
- Diarrhea
- Keywords
- Travelers' diarrhea, rifaximin, prophylaxis, enterotoxigenic E. coli
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants
- Lead sponsor
- DuPont, Hurbert L., MD
- Collaborators
- Bausch Health Americas, Inc., The University of Texas Health Science Center, Houston
- Study start
- Jun 2003
- Study completion
- Sep 2003
- First posted
- 8 Dec 2004 (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 evaluate the effectiveness of poorly absorbed rifaximin in the prevention of travelers' diarrhea among U.S. college students in Mexico for five weeks.
Detailed description
This is an investigator-initiated proposal wherein 220 male and female subjects >17 years of age from industrialized regions were randomized to receive a poorly absorbed antibiotic, rifaximin, in one of three doses at mealtime (when they are exposed to diarrhea-causing bacteria), 200 mg once a day, 200 mg twice a day or 200 mg three times a day versus a placebo starting on arrival (within the first 72 hours) to Mexico and continuing for two weeks with diaries of symptoms recorded for three weeks. Adverse events in the subjects were followed for five weeks. If mild diarrhea (1 or 2 unformed stools/24 hours plus an enteric symptom) or diarrheal illness (>2 unformed stools/24 hours plus an enteric symptom) developed, subjects provided a stool sample to determine cause of illness. Forty subjects provided stool samples after 7 days and 14 days treatment to see if their intestinal bacterial flora had developed resistance to rifaximin and to see the level of drug achieved. Stool samples from these forty subjects were studied for enteric pathogens to look for asymptomatic infection during the period of prophylaxis. The stool samples collected were initially processed in our enteric laboratories in Guadalajara, Mexico. Specialized tests such as studies of toxigenicity for enterotoxigenic E. coli and enteroadherence for enteroaggregative E. coli were done in Houston.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- An Investigational Review Board approved, written informed consent is appropriately witnessed, signed and dated prior to any study-related activities
- Male or female subjects 18 years of age or older
- Able to read and understand English
- Enrolled and started on prophylaxis within 72 hours of arrival in Mexico
- If the subject is female, only women with non-childbearing potential or those who are not pregnant will be eligible. Urine pregnancy tests will be performed on those women who question their pregnancy status. Women on the study are required to employ a reliable method of contraception while taking medication. Forms of acceptable contraception include:
Key exclusion criteria (9 listed)
- Acute diarrhea (criteria for travelers' diarrhea above) within the past week
- Diarrhea developing within 24 hours of study enrollment
- In Mexico for more than 72 hours
- Receipt of one of the following classes of drugs: fluoroquinolone (any drug in class), macrolide or azalide or trimethoprim-sulfamethoxazole within the past week or during the three week study
- Receipt of other medication to decrease the occurrence of diarrhea (e.g. bismuth subsalicylate or lactobacillus preparations)
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 |
|---|---|---|
| rifaximin | Drug | – |
Primary outcome
Occurrence of diarrhea, defined as passage of >2 unformed stools/24 hr plus one or more signs or symptoms of enteric infection
3 secondary outcomes
Occurrence of mild diarrhea (1 or 2 unformed stools/24 hr plus a sign or symptom)
Treatment failure (not well in five days)
Occurrence of moderate to severe abdominal pain/cramps or intestinal gas related symptoms
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 9 May 2006.
- Background: PubMed 11692292DuPont HL, Jiang ZD, Ericsson CD, Adachi JA, Mathewson JJ, DuPont MW, Palazzini E, Riopel LM, Ashley D, Martinez-Sandoval F. Rifaximin versus ciprofloxacin for the treatment of traveler's diarrhea: a randomized, double-blind clinical trial. Clin Infect Dis. 2001 Dec 1;33(11):1807-15. doi: 10.1086/323814. Epub 2001 Oct 23.
- Background: PubMed 8502272DuPont HL, Ericsson CD. Prevention and treatment of traveler's diarrhea. N Engl J Med. 1993 Jun 24;328(25):1821-7. doi: 10.1056/NEJM199306243282507. No abstract available.
- Results publication: PubMed 15897530DuPont HL, Jiang ZD, Okhuysen PC, Ericsson CD, de la Cabada FJ, Ke S, DuPont MW, Martinez-Sandoval F. A randomized, double-blind, placebo-controlled trial of rifaximin to prevent travelers' diarrhea. Ann Intern Med. 2005 May 17;142(10):805-12. doi: 10.7326/0003-4819-142-10-200505170-00005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 rifaximin in people with Diarrhea, run by DuPont, Hurbert L., MD at 1 site in Mexico.
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 12 inclusion and 9 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 9 May 2006. 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 Mexico. 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. 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?
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?
Occurrence of diarrhea, defined as passage of >2 unformed stools/24 hr plus one or more signs or symptoms of enteric infection. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00098384, which also lists 3 linked publications.
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 9 May 2006.