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rifaximin Clinical Trials

Rifaximin for Chronic Immune Activation in People With HIV
Background: - Human immunodeficiency virus (HIV) treatment can control the amount of virus in the blood, but it does not provide a cure. The reasons why HIV treatment does not cure the [more...]  infection are not well understood. HIV persists in blood cells for years, even if people receive treatment for it. In addition, HIV infection leads to an activated immune system, which can cause other problems. - One theory for why HIV infection causes immune activation involves the intestinal tract. HIV infects immune cells the intestine soon after infection and damages their immune barrier. This damage lets bacteria cross into the bloodstream, leading to ongoing inflammation. Even when a person with HIV feels well, this chronic inflammation may affect the immune system. Researchers want to see if the antibiotic Rifaximin can reduce this inflammation. Rifaximin is designed to stay inside the digestive system, so it affects only bacteria in the intestines. Objectives: - To see if Rifaximin can reduce bacteria-related inflammation in people with HIV. Eligibility: - Individuals at least 18 years of age who have HIV infection and are taking medications to treat it. Design: - Participants will be screened with a physical exam, blood test, and medical history. - Participants will take either Rifaximin or a placebo for 4 weeks. They will have no medication for 4 to 6 weeks, and then take the other drug for 4 more weeks. - During the study, participants will have frequent blood and urine tests. They will also provide stool samples. Liver and kidney function tests will be performed. HIV viral load (the amount of virus in the blood) will also be studied. - Participants will have a final follow-up visit after an additional 4 weeks. - Two additional tests are optional for study participants: - Two blood draws: one on the third day after starting Rifaximin, and one on the third day after starting the placebo. - Up to three colonoscopies of the lower intestine and biopsies of the intestine. These studies will collect samples of the intestinal tract to look at the effects of Rifaximin in the study.
Status: Recruiting Start Date: January 2013 Completion Date: October 2014
The Role of Bacterial Overgrowth and Delayed Intestinal Transit in Hepatic Encephalopathy.
This is a prospective study designed to examine the role of bacterial overgrowth and delayed intestinal transit and the effect of Rifaximin with hepatic encephalopathy (HE). This study is divided into Phase A and Phase B. The purpose of Phase A is to test [more...]  patients with cirrhosis to determine if they have bacterial overgrowth which may lead to slow intestinal transit and hepatic encephalopathy. The purpose of Phase B is to investigate whether the improvement found in patients with hepatic encephalopathy taking Rifaximin is also related to decreased bacterial overgrowth. The target population is patients with chronic liver cirrhosis with or without symptoms of HE. Many patients may present with advanced cirrhosis and may be on the liver transplant list. During Phase A, 20 patients will be asked to sign the informed consent form and will be assigned a subject number. They will be asked to provide demographic information, medical history, history of hospitalizations for HE, and HE medication use. They will undergo a complete physical examination, urine pregnancy test (women of childbearing potential), 12-lead EKG, grading of ascites, modified Child Pugh Score, MELD Score. They will also complete the following neuropsychological questionnaires: NCT, D-KEFS Trail Making Test, California Verbal Learning Test, WAIS-III Digit Symbol-Coding and Block Design, D-KEFS Stroop Color-Word Test, Evaluation of Constructional Apraxia, , and asterixis. During the evaluatin visit (a minimum of 3 days after the Screening Visit) the following procedures will be performed: lab tests (chemistry and hematology panels). They will also complete the following questionnaires: Liver Disease Quality of Life Questionnaire, Fisk Fatigue Impact Score, Flatulence Survey, Epworth Sleepiness Scale. Finally, they will undergo a Lactulose Hydrogen Breath Test: This test is designed to evaluate both intestinal transit and bacterial overgrowth. Participants in Phase B will be administered of 550 mg of Rifaximin two times a day for 14 days. Patients will be scheduled to come in on day 14 of the active study period. The follow up visit is day 28, where some of the tests described above will be repeated. During Phase B, patients will be asked to undergo a complete physical examination, a Neurological Examination [including calculation of modified Child Pugh and MELD Score NCT, and Trail Making Test], evaluation of constructional apraxia and asterixis. In addition, the researchers will make sure the patient meets eligibility criteria for participation in open label trial of Rifaximin. They will be administered the first dose study drug (Rifaximin) by study coordinator or investigator and they will be dispensed the study drug needed for the remainder of the trial and a diary for them to record daily flatulence. A urine pregnancy test will be performed within 48 hours of first study dose (for women of childbearing potential). During Day 14 and Day 28 visits, patients will have 1 tablespoon of blood drawn for measurement of the ammonia level and to monitor for potential blood clots. They will complete the NCT, Trails Test, Digit Symbol-Coding, Block Design, and Stroop Tests. They will also complete the Liver Disease Quality of Life Questionnaire, Fisk Fatigue Impact Score, Flatulence Survey (A diary will be provided to the patient with instructions on how to record flatulence experiences on a daily basis), and the Epworth Sleepiness Scale questionnaires. In addition, on Day 14, they will undergo another Lactulose Hydrogen Breath Test. Subjects' mental capacity will be assessed at each visit via interview, brief mental status, questionnaires and psychometric evaluation. Any subject who appears to have lost capacity to continue participation, as evidenced by HE grade 2 or higher, a lack of attentiveness, concentration, or understanding of evaluation, will be discontinued from the study. Female subjects of childbearing potential will be asked to comply with the use of contraception during the Phase B study period as well as throughout the time they remain on study drug. Following completion of the study, patients will be categorized by the degree of HE. To determine whether impaired intestinal transit and bacterial overgrowth are associated with severity of HE, multivariate analysis will be performed to determine whether the independent factors of liver disease severity, intestinal transit, and bacterial overgrowth are significant predictors of the presence and severity of HE. Also, to determine whether treatment with Rifaximin improves bacterial overgrowth, ammonia levels, and HE, changes in Breath Test analysis be correlated will be correlated with changes in ammonia levels and HE.
Status: Recruiting Start Date: September 2012 Completion Date: January 2015
The Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy
The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.
Status: Recruiting Start Date: April 2013 Completion Date: December 2014
The Safety/Efficacy Of Rifaximin With/Without Lactulose In Subjects With A History Of Recurrent Hepatic Encephalopathy
The purpose of the study is to evaluate if Rifaximin alone or Rifaximin plus Lactulose delays the onset of hepatic encephalopathy (HE) in cirrhotic subjects who have had a previous episode of HE.
Status: Recruiting Start Date: January 2013 Completion Date: June 2014
Intestinal Decontamination With Rifaximin. The Inflammatory and Circulatory State in Patients With Cirrhosis
This investigational trial will be assessing the effect of rifaximin on pathophysiology and haemodynamics in the patient with liver cirrhosis, and addressing the effect of rifaximin on several organs on marker level. The molecular and physiological effects of rifaximin will be [more...]  explored. The investigators hypothesize that intestinal decontamination with rifaximin in patients with cirrhosis and ascites will interrupt bacterial translocation from the gut, diminish the following inflammatory response, prevent splanchnic vasodilatation and portal systemic contraction and thereby reduce the risk clinical complications to cirrhosis. If rifaximin can correct small intestinal bacterial overgrowth and demonstrate improvement in liver haemodynamics, renal function and systemic dynamics, then these effects may contribute to the overall well-being of the patient and prevent complications to the underlying cirrhosis such as risk of infections, progression of disease, and admission to hospital.
Status: Recruiting Start Date: November 2012 Completion Date: May 2015
Evaluation of the Metabolome in Diverticular Disease
To evaluate the effect of the probiotic formulation VSL#3 on the metabolome of diverticular disease, comparing it with the effects exerted by supplementation with fibers, by rifaximin and by mesalazine, and assessing the evolution over time after each specific treatment
Status: Recruiting Start Date: December 2012 Completion Date: December 2013
Rifaximin for Preventing Relapse of Clostridium Associated Diarrhoea
Clostridium difficile associated diarrhoea is an important cause of morbidity in patients treated with antibiotics, especially in hospital. Clinical relapse occurs after up to 30% of initially successful treatments for colitis. Preliminary reports suggest that Rifaximin, a poorly absorbed [more...]  antibiotic used to treat travellers diarrhoea can prevent relapse. We plan to carry out a randomised placebo controlled trial to test the hypothesis that Rifaximin given in a reducing dose over 4 weeks after successful treatment will reduce the relapse rate.
Status: Recruiting Start Date: October 2012 Completion Date: April 2015
Weight Loss in Parkinson's Disease and Role of Small Bowel Bacterial Overgrowth
The potential role of Small bowel bacterial overgrowth (SBBO) in weight loss occurring in patients with PD has not previously been examined. Our hypothesis is that SBBO is an important contributor to the development of weight loss in individuals with Parkinson's [more...]  disease. The investigators propose to 1) examine the role of SBBO in weight loss occurring in patients with PD and 2) determine the response to its treatment with a poorly absorbed antibiotic. The investigators propose to perform a prospective, observational case-control study with an open-label therapeutic component. Cases will be defined as those PD patients who've experienced significant weight loss while Controls will be defined as those PD patients who have not experienced significant weight loss.
Status: Recruiting Start Date: September 2012 Completion Date: September 2014
Impact of an Antibiotic (Rifaximin) on Liver Scarring in HIV-Infected Patients With Liver Disease
For HIV-infected patients who have access to treatment, liver diseases are a major cause of morbidity and mortality. Hepatitis C is the most frequently encountered liver condition in this population. Both diseases allow a higher level of poisonous substances (toxins) [more...]  normally produced by the bacteria present in the gut to enter the bloodstream. This leads to a chronic inflammatory state, which results in faster development of liver scars (fibrosis) and ultimately, end stage disease (cirrhosis). To prevent this from happening, the use of antibiotics has been attempted to reduce the quantity of gut flora in the hopes of lowering the amount of toxins produced. These trials have shown promising results, but the antibiotics studied had major side effects and were not designed for continuous use. Rifaximin is a non absorbable antibiotic with very few side effects. It is already used for long periods of time in cirrhotic patients to treat the effects of cirrhosis on the brain (encephalopathy). This project will try to determine if rifaximin, by reducing the level of toxins produced by the bacteria in the gut, can improve the evolution of liver fibrosis in HIV-infected patients with hepatitis C. In this pilot study, ten patients will be followed for one year. They will be included if they are starting on rifaximin, for its currently approved FDA indication (hepatic encephalopathy).
Status: Recruiting Start Date: October 2012 Completion Date: September 2013
Rifaximin for Functional Dyspepsia
Functional dyspepsia is a very common medical condition, which occurs in up to 30% of people in the community. However, results of current pharmacological treatment on functional dyspepsia are unsatisfactory. Rifaximin is a minimally absorbed antibiotic that has been [more...]  used in treatment of non-constipated irritable bowel syndrome (IBS). In particular, bloating and abdominal pain was improved by rifaximin treatment in this group of IBS patients. Whilst there is considerable overlap in symptoms of functional dyspepsia and IBS, the investigators test whether rifaximin is also effective in curing post-prandial distress symptoms related to dyspepsia.
Status: Recruiting Start Date: January 2013 Completion Date: December 2015
Rifaximin to Prevent Recurrent HCV-Related Fibrosis After Liver Transplant
The purpose of this study is to determine if the administration of a poorly-absorbable antibiotic (rifaximin) for the first three months after liver transplant will reduce the amount of fibrosis (or scarring of the liver) in liver transplant patients with recurrent [more...]  hepatitis C virus (HCV) by lowering serum lipopolysaccharide (LPS), a protein in blood that comes from the bacteria in intestines and may cause scarring in the liver. Approximately 60 subjects will participate in this study. Subjects will be part of the study for approximately 1 year post transplant.
Status: Recruiting Start Date: March 2012 Completion Date: March 2014
Irritable Bowel Syndrome With Diarrhea (IBS-D) Rifaximin Re-Treatment Study
This study will evaluate the effectiveness and safety of repeat treatment with rifaximin 550 mg three times a day in patients with IBS with diarrhea who respond to initial treatment of rifaximin 550 mg three times a day.
Status: Recruiting Start Date: February 2012 Completion Date: 
Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex
The adverse impact of Gulf War Syndrome (GWS) on the health of veterans and on the resources of the VA Healthcare System underscores the need to resolve its underlying cause. In response, the investigators propose to investigate the central hypothesis that gut bacteria [more...]  may be responsible for symptoms associated with GWS. The investigators will enroll a total of 120 patients with GWS and 90 healthy controls.
Status: Recruiting Start Date: April 2009 Completion Date: 
Rifaximin Versus Lactulose in Renal Failure
The purpose of this study is to evaluate patients with cirrhosis of the liver and renal failure and determine if the administration of rifaximin as compared to lactulose is associated with less frequent and/or slower progression to severe hepatic encephalopathy. If [more...]  one is associated with lower blood ammonia levels. And, if one is associated with lower breath hydrogen and methane levels.
Status: Recruiting Start Date: June 2008 Completion Date: July 2009
Induction of Clinical Response Using Rifaximin in Crohn's Disease
Antibiotics have been used to treat Crohn's disease symptoms with the best studied antibiotics being Cipro and Flagyl. Rifaximin is a poorly absorbed oral antibiotic that is FDA approved for travelers' diarrhea. It works by inhibiting bacterial reproduction. It is [more...]  very poorly absorbed and over 97% of the drug taken orally is excreted in the feces. The purpose of this study is to evaluate the potential benefits and safety of Rifaximin for the treatment of moderate to severe symptoms of Crohn's Disease.
Status: Recruiting Start Date: November 2008 Completion Date: December 2012
Pilot Study Of The Effect Of Rifaximin On B-Cell Dysregulation In Cirrhosis
Hepatitis C is the leading cause of chronic liver disease and cirrhosis in United States veterans. Cirrhosis is associated with impaired antibody responses and increased risk of bacterial infections. We have recently identified that cirrhosis is associated with abnormalities [more...]  of memory B-cells, cells that make antibodies and help protect against bacterial infections. We have identified that chemicals associated with gut bacteria might play a role in causing these B-cell abnormalities. It is well known that gut bacteria have increased access to the blood in individuals with cirrhosis, a process called bacterial translocation. We hypothesize that reducing bacteria counts in the gut by using poorly-absorbed antibiotics (also known as selective gut decontamination) will partially reverse losses of memory B-cells in cirrhosis by reducing bacterial translocation.
Status: Not yet recruiting Start Date: January 2014 Completion Date: 
The Rifaximin Study
Patients with Common variable immunodeficiency (CVID) have various forms of autoimmune and auto inflammatory disorders. The study will investigate if intervention with Rifaximin modifies the gut microbiota with a subsequent alteration in markers of systemic immune activation and inflammation [more...]  in patients with CVID. The investigators hypothesize that the gut microbiota of CVID patients, at least partly through interaction with the innate immune system within the intestine, contribute to a low-grade systemic inflammation in these patients, and that an intervention with the non-absorbable antibiotic Rifaximin attenuates systemic inflammation through modulation of the gut microbiota. The study may lead to increased understanding of the interaction between microbiota and the immune system. The study could give new insight into important disease processes in relation to the interaction between the microbiota, the intestine and the systemic compartment, and potentially be the basis of new therapeutic strategies in these patients to prevent and down-regulate the auto-inflammatory and autoimmune complications seen in CVID. The findings could also be of relevance for other disorders where the interaction between microbiota and intestinal and systemic inflammation is involved such as various cardiovascular and metabolic disorders. The investigators hypothesize that the gut microbiota of CVID patients, at least partly through interaction with the innate immune system within the intestine, contribute to a low-grade systemic inflammation in these patients, and that an intervention with the non-absorbable antibiotic Rifaximin attenuates systemic inflammation through modulation of the gut microbiota.
Status: Not yet recruiting Start Date: October 2014 Completion Date: 
Rifaximin and Placebo in the Treatment of Bowel Dysfunction After Anterior Resection for Rectal Cancer
The most common long-term problems after rectal surgery are bowel problems. These problems can include needing to pass bowel movements a lot, loose or mushy stools, inability to fully clear your bowels, and/or poor control of gas and stool. The investigators believe that a [more...]  major cause of these problems is too much bacteria in the bowel and treatment with antibiotic tablets will hopefully help improve these bowel problems. In order to test this idea, the Colorectal Surgery Service of Memorial Sloan Kettering Cancer Center is sponsoring a clinical trial. This trial will compare the antibiotic rifaximin and a placebo (a harmless tablet that has no effect) in the treatment of these bowel problems. Following this we will attempt to see if another antibiotic metronidazole also helps to treat these bowel problems. Both Metronidazole and rifaximin are well established drugs that have minimal side effects.
Status: Active, not recruiting Start Date: April 2011 Completion Date: April 2014
Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin
The aim of the study is to investigate the efficacy of the prophylactic treatment with rifaximin to prevent travellers diarrhoea.
Status: Active, not recruiting Start Date: October 2009 Completion Date: October 2012
Gulf War Digestive Health Study
The purposes of this study are to estimate the burden of disease due to chronic gastrointestinal illness in PG veterans, to evaluate whether SBBO is associated with chronic diarrhea in PG veterans, and to determine whether eradication of SBBO reduces symptoms of [more...]  chronic diarrhea, abdominal pain and bloating in PG veterans.
Status: Active, not recruiting Start Date: October 2007 Completion Date: December 2013
A Clinical Study to Limit Physiologic Intestinal FDG Uptake Uptake on PET-CT Scans
Patients who undergo PET-CT scans to look for cancer are given an intravenous contrast (FDG) that is taken-up by active cells such as cancer cells. This contrast can then be seen in the body using the PET-CT scanner. However, cells in the colon also [more...]  take up the FDG, and can produce "false positive" signals from the colon. Our hypothesis is that much of this signal comes from bacteria that are present in high concentrations in the colon. If this is the case, using an antibiotic to suppress the activity of bacteria may improve the ability of PET-CT to distinguish abnormal cells from normal cells in the colon.
Status: Completed Start Date: July 2011 Completion Date: October 2012
Rifaximin as a Modulator of Microbial Translocation and Immune Activation
This study is being done to see whether rifaximin, an antibiotic that works in the intestines, can lower the amount of germs in the intestines of HIV infected persons. It is possible that when the amount of these germs is lowered, an HIV-infected person's [more...]  immune system will become less active and will have a better chance of recovering. Also, the study will evaluate the safety of using rifaximin in HIV-infected subjects.
Status: Completed Start Date: September 2011 Completion Date: November 2012
Rifaximin for the Treatment of Persistent Symptoms in Patients With Celiac Disease
Celiac disease is a condition in which the small intestine is damaged by gluten, the storage protein of wheat and similar proteins in barley and rye. The disease can cause different symptoms such as diarrhea, bloating, abdominal pain and weight loss. The majority of [more...]  patients respond to a gluten-free diet. However some patients (5-30%) have persistent symptoms and are considered to be poor responders to the diet. Bacterial overgrowth in the small intestine accounts for some of the refractory patients. This study seeks to determine if antibiotic therapy with rifaximin relieves the symptoms of patients who are poorly responsive to a gluten-free diet and whether this impacts their breath test results.
Status: Completed Start Date: October 2006 Completion Date: April 2008
Study of Rifaximin in Minimal Hepatic Encephalopathy
Rifaximin therapy will improve brain functioning on MRI scanning and change the microbiome and metabolome.
Status: Completed Start Date: February 2010 Completion Date: December 2012
Rifaximin for Preventing Acute Graft Versus Host Disease (AGVHD)
Acute graft versus host disease is a frequent and often life threatening complication of allogeneic blood and marrow transplantation. The bacteria that normally reside in the intestine play a critical role in its development. Injury to the lining of the bowel that [more...]  results from the high dose chemotherapy or radiation that transplant patients receive during the week preceding the transplant allows the bacteria to invade the intestines and spread to nearby lymph nodes. This, in turn, causes inflammation which has been shown to promote GVHD. Both pre-clinical and clinical research has demonstrated that oral antibiotics can prevent graft versus host disease by inhibiting these gut bacteria. Rifaximin has several features that suggest it could be effective in preventing GVHD. Rifaximin prophylaxis might also provide an added benefit by protecting highly immunocompromised transplant patients from severe bacterial infections. This pilot trial will allow the investigators to determine the feasibility of using Rifaximin for prevention of GVHD and infection in patients undergoing allogeneic blood and marrow transplantation. The preliminary results will be used to plan a more definitive trial.
Status: Completed Start Date: April 2007 Completion Date: April 2009
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Clinical trials allow volunteers access to medical treatment options before they are available to the general public. Participants often receive the best healthcare available for their condition.

Risks are a reality, however, and may include more frequent doctor visits, health risks (possibly life-threatening), and/or the treatment being ineffective. Trials are federally regulated with strict guidelines to protect participants.

rifaximin Clinical Trials Information presented on ClinicalTrialsSearch.org is not intended to be a substitute for qualified medical advice visit or treatment with a real physician. We are not physicians. Always consult with a medical doctor (MD). ClinicalTrialsSearch.org is a website dedicated to listing clinical research studies in human subjects, including those specifically related to rifaximin. Clinical research trials and medical trials take place in hundreds of cities across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectiveness of new treatments and drugs. The purpose of the studies is to answer specific human health questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions. Clinical trials allow volunteers access to medical treatment options before they are available to the general public. Many times the participants receive treatment for free, and sometimes they are paid for their time. Participants often receive the best healthcare available possible for their condition. Risks are a reality, however, and may include more frequent doctor visits, health risks (possibly life-threatening), and/or the treatment being ineffective. U.S. - based rifaximin studies are federally regulated with strict guidelines to protect patients.

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