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rifaximin Clinical Trials

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: Recruiting Start Date: April 2007 Completion Date: April 2018
Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia
The prevalence of functional dyspepsia (FD) is estimated to be 15% of the adult population. FD is commonly described as a condition of chronic abdominal discomfort localized to the upper abdomen. Postprandial bloating, pain, nausea, vomiting, belching, and early satiety [more...]  are common symptoms of the FD patient. FD is defined by >12 weeks of symptoms, which need not be consecutive, within the preceding year consisting of a) persistent or recurrent dyspepsia and b) an absence of organic disease after a gastrointestinal endoscopy or x-ray series. FD is therefore considered a disorder of function because no mucosal pathology is seen in these patients, as in patients with other functional disorders such as irritable bowel syndrome (IBS) and fibromyalgia (FM). There is a remarkable degree of overlap among these three disorders. These 3 disorders share the finding of hypersensitivity and the symptom of postprandial bloating to suggest the possibility of a common origin.
Status: Recruiting Start Date: August 2007 Completion Date: 
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: February 2011
Study of Rifaximin in Minimal Hepatic Encephalopathy
Rifaximin therapy will improve brain functioning on MRI scanning.
Status: Recruiting Start Date: February 2010 Completion Date: 
Trial Comparing Neomycin to Rifaximin Plus Neomycin in the Treatment of Methane Positive Subjects With Constipation Predominant Irritable Bowel Syndrome (C-IBS)
In this study the investigators aim to compare the efficacy of neomycin to a combination of rifaximin and neomycin in the treatment of C-IBS subjects with methane on their breath test. This study will be conducted in collaboration with Dr. John DiBaise at the [more...]  Mayo Clinic in Scottsdale, AZ.
Status: Recruiting Start Date: August 2009 Completion Date: May 2012
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
Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex
The adverse impact of 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 may be [more...]  responsible for symptoms associated with GWS. The investigators will enroll a total of 160 patients with GWS and 90 healthy controls. The investigators will assess the prevalence and role of abnormal gut microbial fermentation among Veterans with GWS and investigate the efficacy of diagnostic and treatment strategies directed at indigenous gut microbes in the management of GWS.
Status: Recruiting Start Date: April 2009 Completion Date: 
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: Recruiting Start Date: October 2009 Completion Date: April 2011
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. Rifaximin is a well established drug that has minimal side effects.
Status: Recruiting Start Date: April 2011 Completion Date: April 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 2012
Rifaximin in Fatty Liver Disease
TITLE Rifaximin in Fatty Liver Disease (RiFL) DESIGN Proof-of-principle, open-label, randomised, cross-over, controlled study HYPOTHESIS Reduction in gut flora by the antibiotic Rifaximin reduces hepatic inflammation in Non-Alcoholic Steatohepatitis (NASH). AIMS To provide proof-of-concept data on the therapeutic potential [more...]  of gut flora modification in NASH OUTCOME MEASURES Primary: • Change in serum ALT from baseline by 25 IU/L or to within normal range after 6 weeks of therapy Secondary: - Change in intrahepatic triglyceride, estimated by in vivo proton magnetic resonance spectroscopy (1H MRS) - Change in hepatic insulin resistance, estimated by the hyperinsulinaemic euglycaemic clamp - Changes to the faecal bacterial microbiome assessed by faecal DNA pyrosequencing and fluorescent in-situ hybridisation (FISH) - Differences in urinary metabolic profiles as assessed by high-resolution proton nuclear magnetic resonance spectroscopy POPULATION Patients with biopsy-confirmed non-alcoholic steatohepatitis and persistently raised serum aminotransferase levels TREATMENT The non-absorbable antibiotic Rifaximin DURATION Study duration 18 months. Individual patients' participation 18 weeks, with clinical follow-up 3 months after the end of the study.
Status: Active, not recruiting Start Date: May 2011 Completion Date: September 2012
Rifaximin in Minimal Hepatic Encephalopathy
The purpose of this study is to determine whether alteration of gut flora with rifaximin can lead to improvement in driving performance, psychometric test performance, and quality of life in patients with minimal hepatic encephalopathy (MHE) and cirrhosis in a randomized, [more...]  blinded, placebo-controlled trial.
Status: Completed Start Date: October 2007 Completion Date: May 2010
Study to Assess the Efficacy and Safety of Rifaximin Administered BID in the Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome
This is placebo-controlled study of three rifaximin doses in patients with DIBS. Subjects will be randomized to receive daily doses of placebo BID, rifaximin 275 mg BID, rifaximin 550 mg BID, or 1100 mg BID for 14 days. These four groups will [more...]  subsequently receive an additional two weeks of placebo for a total of 4 weeks of treatment. A fifth group of subjects will receive rifaximin 550 mg BID for a period of 28 days. Subjects who successfully respond to treatment at the end of the 28-day Treatment Phase will be followed in a Post-treatment Phase that includes study visits during Weeks 6, 8, 12 and 16. Subjects who relapse during the Post-treatment Phase will be discontinued from the study.
Status: Completed Start Date: December 2005 Completion Date: September 2008
Open-Label Study to Evaluate the Effect of Rifaximin on Midazolam in Normal Healthy Volunteers
The primary objective of this study is to determine if rifaximin, administered daily has an effect on the cytochrome P450 (CYP) isoenzyme 3A4, by examining any changes in the pharmacokinetics of midazolam (a CYP3A4 substrate), when co-administered.
Status: Completed Start Date: September 2008 Completion Date: November 2008
Safety Study for Patients With a History of Hepatic Encephalopathy
This study will look at the safety of a drug used in patients who have had hepatic encephalopathy in the past.
Status: Completed Start Date: March 2007 Completion Date: 
Antibiotics for the Treatment of Ulcerative Colitis
Ulcerative colitis (UC) is an acute and chronic inflammatory bowel disease, whose cause is unknown. However, it is widely accepted that bacteria living in the large bowel are essential for the development of the disease. Intuitively, therefore, a logical approach to [more...]  treatment would be to use antibiotics. However, antimicrobial chemotherapy has been unsuccessful in managing acute colitis, and has had only limited benefit in long-term treatment. The failure of antibiotics in UC arises from the fact that no-one has tried to identify which bacteria are involved in causing disease, and equally importantly, nobody has targeted appropriate antibiotics to knock out the specific bacteria in question, in a systematic way. Despite this, increasing evidence implicates bacteria living on the lining of the bowel being involved in UC. Our aim, therefore is to identify bacteria colonizing the mucosal surface in the lower large intestine and to determine the antibiotic sensitivities of those the investigators believe to be particularly involved in the disease, such as enterococcit, peptostreptococci and enterobacteria. Because the investigators have already studied resistance to antimicrobial in many mucosal isolate, the investigators plan ot focus on using a combination of two antibiotics in this work. A controlled trial will test the benefit of using these antibiotics over a period of one month and then the patients will be followed up over a six month period. The investigators will be looking for significant long-term improvements, and a reduction in drug use following antibiotic therapy.
Status: Completed Start Date: July 2006 Completion Date: December 2008
Rifaximin 3 Times/Day for Non-constipation IBS
To evaluate the efficacy of a 14-day course of rifaximin given 3 times a day vs. placebo in providing adequate relief of IBS symptoms.
Status: Completed Start Date: July 2008 Completion Date: September 2009
A 6-month Efficacy, Safety and Tolerability Study of Rifaximin In Preventing Hepatic Encephalopathy
The purpose of this study is to determine if the study drug is safe and effective in preventing Hepatic Encephalopathy (HE).
Status: Completed Start Date: December 2005 Completion Date: April 2009
Rifaximin for the Treatment of Irritable Bowel Syndrome
We have recently shown that the majority of patients with irritable bowel syndrome (IBS) have an abnormal lactulose breath test to suggest the presence of bacterial overgrowth of the small intestine. In open label and double blind treatment of IBS subjects with [more...]  antibiotics, a dramatic improvement in clinical symptoms are observed. In these studies, the antibiotic chosen was neomycin, which is noted to have an efficacy of 20-25% in normalizing the lactulose breath test. A more efficacious antibiotic is needed. Therefore the aim of this study is to determine the efficacy of rifaximin in normalizing the lactulose breath test in IBS subjects with concomitant improvement in clinical symptoms.
Status: Completed Start Date: July 2003 Completion Date: January 2007
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
Rifaximin for Prevention of Travellers' Diarrhea
The purpose of this study is to determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.
Status: Completed Start Date: June 2005 Completion Date: April 2007
Rifaximin TID for Non-constipation Irritable Bowel Syndrome (IBS)
To evaluate the efficacy of a 14-day course of rifaximin given 3 times a day vs. placebo in providing adequate relief of IBS symptoms.
Status: Completed Start Date: July 2008 Completion Date: September 2009
Prevention of Travelers' Diarrhea in Subjects Traveling Outside the U.S.
The primary objective of this study is to assess the safety and tolerability of rifaximin 600 mg (3 x 200-mg tablets) once daily compared with placebo when taken for 14 days by healthy subjects to prevent travelers' diarrhea (TD) from all causes.
Status: Completed Start Date: December 2005 Completion Date: September 2008
Rifaximin Versus Placebo in the Prevention of Travelers' Diarrhea
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.
Status: Completed Start Date: June 2003 Completion Date: September 2003
Trial of Rifaximin in the Treatment of Tropical Enteropathy
The purpose of this study is to determine whether rifaximin is effective in the treatment of tropical enteropathy in a population of African children at high risk for this disease.
Status: Completed Start Date:  Completion Date: 
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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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