Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT02738905
NCT02738905WithdrawnEarly Phase 1

Impact of Rifaximin Therapy on Intestinal Byproducts in End-Stage Renal Disease

Jason Stubbs, MD2 sites in 1 countryStarted: January 2016Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Early Phase 1
Status
Withdrawn
Sponsor
Locations
2
Primary Endpoint
Change in serum TMAO levels
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to determine if rifaximin reduces serum trimethylamine-N-oxide (TMAO) levels in patients with end-stage renal disease.

Detailed Description

Study participants will undergo 3 study visits: baseline, day 7 (immediately post-therapy), day 21 (2 weeks post-therapy). All participants will provide blood and stool samples at each visit.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Diagnosis of end-stage renal disease
  • •Receiving chronic intermittent hemodialysis

Exclusion Criteria

  • •Patients with less advanced kidney disease
  • •Inability or unwillingness to provide informed consent
  • •Patients who may be pregnant
  • •Hemodynamically unstable patients
  • •Patients with liver failure, pancreatic insufficiency, or inflammatory bowel disease
  • •Patients with ongoing or recent infection and those with history of C-diff infection
  • •Patients with abnormal bowel structure secondary to surgical or anatomic variations
  • •Patients on certain medications, including immunosuppressants, antidiarrheal agents, or recent (within the last 2 months) use of antibiotics

Arms & Interventions

Rifaximin

Experimental

Participants will receive study drug for a period of 7 days.

Intervention: Rifaximin (Drug)

Outcomes

Primary Outcomes

Change in serum TMAO levels

Time Frame: Change from Baseline to Day 7

Secondary Outcomes

  • Change in fecal bacterial species(Change from Baseline to Day 21)
  • Change in serum TMAO levels(Change from Baseline to Day 21)
  • Change in fecal bacterial colony numbers(Change from Baseline to Day 21)

Investigators

Sponsor
Jason Stubbs, MD
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Jason Stubbs, MD

Associate Professor

University of Kansas Medical Center

Study Sites (2)

Loading locations...

Similar Trials

Completed
Phase 4
Rifaximin Therapy in Chronic Kidney DiseaseChronic Kidney Disease
NCT02342639Jason Stubbs, MD38
Completed
Phase 4
Intestinal Decontamination With Rifaximin. The Inflammatory and Circulatory State in Patients With CirrhosisAscitesLiver Cirrhosis
NCT01769040Copenhagen University Hospital, Hvidovre54
Active, not recruiting
Not Applicable
Intestinal decontamination with rifaximiiver cirrhosis of any etilogy, complicated by decompensation and classified as Child-Pugh B or CMedDRA version: 17.1Level: LLTClassification code 10024667Term: Liver cirrhosisSystem Organ Class: 100000004871
EUCTR2012-002890-71-DKFlemming Bendtsen
Completed
Not Applicable
The effect of rifaximin on small intestinal motility and microbiota in patients with liver cirrhosisiver cirrhosis
JPRN-UMIN000028986Division of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Niigata University20
Recruiting
Phase 3
The effect of rifaximin in IBSIrritable bowel syndrome.Irritable bowel syndrome
IRCT20221211056775N1Arak University of Medical Sciences60