Rifaximin

Generic Name: Rifaximin

Brand Names: Xifaxan, Zaxine

Drug Type: Small Molecule

Chemical Formula: C_₄₃H_₅₁N_₃O_₁₁

CAS Number: 80621-81-4

Unique Ingredient Identifier: L36O5T016N

Background: Rifaximin is a semisynthetic, rifamycin-based non-systemic antibiotic, meaning that the drug will not pass the gastrointestinal wall into the circulation as is common for other types of orally administered antibiotics. It has multiple indications and is used in treatment of traveller's diarrhea caused by E. coli; reduction in risk of overt hepatic encephalopathy recurrence; as well as diarrhea-predominant irritable bowel syndrome (IBS-D) in adult women and men. It is marketed under the brand name Xifaxan by Salix Pharmaceuticals.

Indication: Rifaximin has multiple indications by the FDA: for the treatment of patients (≥12 years of age) with traveller's diarrhea caused by noninvasive strains of Escherichia coli; for the reduction of overt hepatic encephalopathy recurrence in patients ≥18 years of age; and in May 2015 it was approved for irritable bowel syndrome with diarrhea (IBS-D) treatment in adult men and women.

Associated Conditions: Bacterial Infections, Clostridium difficile infection recurrence, Hepatic Encephalopathy (HE), Irritable Bowel Syndrome (IBS), Traveler's Diarrhea

Clinical Trials

Rifaximin Therapy vs Low FODMAP Diet In IBS

Phase 4

Recruiting

Conditions: Irritable Bowel Syndrome
Small Intestinal Bacterial Overgrowth

Interventions: Other: Low FODMAP diet
Drug: Rifaximin

First Posted Date: 2021-04-12

Last Posted Date: 2023-05-16

Lead Sponsor: University of Malaya

Target Recruit Count: 100

Registration Number: NCT04841980

Locations: 🇲🇾
University Malaya Medical Centre, Kuala Lumpur, Malaysia

Efficacy and Safety of E.Coli Nissle 1917 in Patients With Mild (Stage 1-2) or Minimal Hepatic Encephalopathy

Not Applicable

Completed

Conditions: Hepatic Encephalopathy
Liver Cirrhosis
End Stage Liver DIsease

Interventions: Dietary Supplement: E.coli Nissle 1917
Drug: Rifaximin
Drug: Lactulose

First Posted Date: 2021-03-08

Last Posted Date: 2021-03-08

Lead Sponsor: Bogomolets National Medical University

Target Recruit Count: 42

Registration Number: NCT04787276

Primary Prophylaxis for Spontaneous Bacterial Peritonitis

Phase 2

Terminated

Conditions: Small Bowel Bacterial Overgrowth Syndrome
Decompensated Cirrhosis

Interventions: Drug: Rifaximin

First Posted Date: 2021-03-01

Last Posted Date: 2023-01-06

Lead Sponsor: Changi General Hospital

Target Recruit Count: 2

Registration Number: NCT04775329

Locations: 🇸🇬
Wong Yu Jun, Singapore, Singapore

Microbial Resistance of Rifaximin in Hepatic Encephalopathy

Phase 4

Completed

Conditions: Hepatic Encephalopathy

Interventions: Drug: Rifaximin

First Posted Date: 2021-02-03

Last Posted Date: 2021-02-03

Lead Sponsor: National Hepatology & Tropical Medicine Research Institute

Target Recruit Count: 100

Registration Number: NCT04736836

Weight Loss Benefits of Rifaximin in an Intermittent Fasting Diet

Phase 4

Conditions: Weight Loss

Interventions: Drug: Rifaximin

First Posted Date: 2020-12-19

Last Posted Date: 2020-12-19

Lead Sponsor: Bayhealth Medical Center

Target Recruit Count: 30

Registration Number: NCT04674176

Locations: 🇺🇸
Bayhealth Medical Center- Dover Family Physicians and GI Consultants Office, Dover, Delaware, United States

Efficacy and Safety of Rifaximin With NAC in IBS-D

Phase 1

Completed

Conditions: Irritable Bowel Syndrome With Diarrhea

Interventions: Drug: Rifaximin
Drug: Placebo
Drug: N-acetylcysteine

First Posted Date: 2020-09-21

Last Posted Date: 2023-03-28

Lead Sponsor: Cedars-Sinai Medical Center

Target Recruit Count: 45

Registration Number: NCT04557215

Locations: 🇺🇸
Cedars-Sinai Medical Center, Los Angeles, California, United States

Randomised, Placebo-controlled Safety and Pharmacokinetics Study of Novel Rifaximin Formulations in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Rifaximin Novel Formulation
Drug: Placebo

First Posted Date: 2020-08-28

Last Posted Date: 2021-06-18

Lead Sponsor: Bausch Health Americas, Inc.

Target Recruit Count: 124

Registration Number: NCT04529811

Locations: 🇳🇿
Auckland Clinical Studies, Grafton, Auckland, New Zealand

Effect of a Probiotic Formula on Reducing SIBO in IBS Patients

Not Applicable

Terminated

Conditions: Irritable Bowel Syndrome
Small Intestinal Bacterial Overgrowth

Interventions: Drug: Rifaximin
Dietary Supplement: Probiotic

First Posted Date: 2020-03-20

Last Posted Date: 2022-11-08

Lead Sponsor: AB Biotics, SA

Target Recruit Count: 8

Registration Number: NCT04316806

Locations: 🇪🇸
Dr. Bofill Clinic, Girona, Spain

Multi-dimensional Clinical and Pathophysiological Profiles of Patients With Functional Dyspepsia and Effect of Gut Microbiota Manipulation Using Rifaximin for Its Treatment

Phase 2

Conditions: Dyspepsia

Interventions: Drug: Rifaximin
Drug: Placebo

First Posted Date: 2020-03-10

Last Posted Date: 2020-03-10

Lead Sponsor: Sanjay Gandhi Postgraduate Institute of Medical Sciences

Target Recruit Count: 132

Registration Number: NCT04302402

Locations: 🇮🇳
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS), Lucknow, Uttar Pradesh, India
🇮🇳
Department of Critical Care Medicine, SGPGIMS, Lucknow, UP, India

Rifaximin in Patients With Diabetic Gastroparesis

Phase 2

Suspended

Conditions: Crohn Disease
Diabetic Gastroparesis

Interventions: Drug: Placebo
Drug: Rifaximin

First Posted Date: 2020-02-05

Last Posted Date: 2025-04-27

Lead Sponsor: Mayo Clinic

Target Recruit Count: 40

Registration Number: NCT04254549

Locations: 🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States

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