A Phase 2/3 interventional study of Rifaximin intervention and Placebo intervention in Dysentery, Diarrhea and Enteric Campylobacteriosis, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-20.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Phase 2/3, Interventional, and Prevention
This study is a randomized, double-blinded, placebo-controlled, in-patient trial evaluating the prophylactic efficacy of rifaximin against campylobacteriosis following challenge with C. jejuni.
30 healthy volunteers (2 of these were planned alternates) gave informed consent and were enrolled to participate in a study to determine the efficacy of prophylactic rifaximin in preventing diarrheal illness following challenge with C. jejuni, strain CG8421. Volunteers were screened for inclusion and exclusion criteria and were admitted to the inpatient unit of the Center for Immunization Research at Johns Hopkins University. Volunteers were treated with rifaximin or placebo in a double blind manner for four days, beginning the day prior to challenge. On the day of challenge, the volunteers were given 5x10(5) C. jejuni with bicarbonate buffer and were then monitored and treated for any symptoms. Stools were cultured daily for the excretion of C. jejuni and all subjects were treated with antibiotics to insure that the challenge strain has cleared prior to to discharge. Subjects were followed for six months following the inpatient phase to detect adverse events following the study.
44 studies on the registry are indexed under Dysentery; 6 are open to participants now.
This study's enrollment of 30 is below the median of 163 across 38 interventional studies indexed under Dysentery.
Browse Dysentery studies →Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 371 studies on the registry; 42 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
If the subject is female, she is eligible to enter if she is of:
Exclusion Criteria:
General health/issues
Study-specific exclusionary conditions based on potential increased risk or complicating outcome ascertainment. (See protocol details for complete list of exclusions.)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects receiving rifaximin prophylaxis will be challenged with C. jejuni
Biological: Rifaximin intervention
Subjects receiving placebo will be challenged with C. jejuni
Biological: Placebo intervention
Rifaximin administered then Challenge with C jejuni
Placebo administered then Challenge with C jejuni
Campylobacteriosis
A clinical illness meeting at least one of the following patterns: * Moderate to severe diarrhea. * Fever (present on at least 2 occasions, at least 20 minutes apart) without diarrhea, plus an associated symptom (nausea, vomiting, abdominal cramps, tenesmus, or gross blood in ≥ 2 stools); with consideration of potential alternative diagnosis per clinical investigator based on illness time course and associated symptoms.
Time frame: 120 hours after challenge
| Milestone | Rifaximin | Placebo |
|---|---|---|
| Started | 15 | 15 |
| Completed | 15 | 13 |
| Not completed | 0 | 2 |
| Withdrew: Planned alternate | 0 | 2 |
A clinical illness meeting at least one of the following patterns: * Moderate to severe diarrhea. * Fever (present on at least 2 occasions, at least 20 minutes apart) without diarrhea, plus an associated symptom (nausea, vomiting, abdominal cramps, tenesmus, or gross blood in ≥ 2 stools); with consideration of potential alternative diagnosis per clinical investigator based on illness time course and associated symptoms.
| Participants | Rifaximin | Placebo |
|---|---|---|
| Campylobacteriosis | 13 | 11 |
Recovered C jejuni from fecal specimen on follow-up after an apparent cure
| Participants | Rifaximin | Placebo |
|---|---|---|
| Recrudescent Events | 2 | 3 |
Collected over 84 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rifaximin | 0/15 (0%) | 0/15 (0%) | 13/15 (86.7%) |
| Placebo | 0/13 (0%) | 0/13 (0%) | 13/13 (100%) |
| Event | Rifaximin | Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 6/15 | 9/13 |
| Abdominal CrampsGastrointestinal disorders | 9/15 | 9/13 |
| HeadacheGeneral disorders | 9/15 | 9/13 |
| ChillsImmune system disorders | 10/15 | 8/13 |
| MalaiseGeneral disorders | 10/15 | 8/13 |
| anorexiaGastrointestinal disorders | 9/15 | 8/13 |
| DysenteryGastrointestinal disorders | 4/15 | 8/13 |
| Abdominal painGastrointestinal disorders | 7/15 | 7/13 |
| BloatingGastrointestinal disorders | 3/15 | 7/13 |
| FeverImmune system disorders | 8/15 | 6/13 |
| Age, Continuous(years) | Rifaximin | Placebo | Total |
|---|---|---|---|
| Median | 30 (29 to 37) | 31 (26 to 41) | 31 (29 to 38) |
| Sex: Female, Male(Participants) | Rifaximin | Placebo | Total |
|---|---|---|---|
| Female | 4 | 5 | 9 |
| Male | 11 | 10 | 21 |
| Race (NIH/OMB)(Participants) | Rifaximin | Placebo | Total |
|---|---|---|---|
| Race — American Indian or Alaska Native | 0 | 0 | 0 |
| Race — Asian | 0 | 0 | 0 |
| Race — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Race — Black or African American | 13 | 14 | 27 |
| Race — White | 1 | 1 | 2 |
| Race — More than one race | 1 | 0 | 1 |
| Race — Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Rifaximin | Placebo | Total |
|---|---|---|---|
| United States | 15 | 15 | 30 |
The record gives a start of Oct 2014, a primary completion of Aug 2016 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2018, 2 years 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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