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Clinical Trials/NCT01186276
NCT01186276
Completed
Not Applicable

Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes

Stanford University3 sites in 1 country58 target enrollmentJuly 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Kidney Failure, Chronic
Sponsor
Stanford University
Enrollment
58
Locations
3
Primary Endpoint
Plasma level of p-cresol sulfate
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This study will assess whether dietary fiber supplements can reduce the production of chemicals which are produced by colon bacteria and normally excreted from the body by the kidney, but build up in the body in patients on hemodialysis.

Detailed Description

The study procedures will consist of: * taking a dietary supplement containing either fiber or starch (starch serves as a control for fiber) for six weeks. The fiber dose initially employed will be 30 g/day of high amylose corn and the control starch dose employed will be 30 g/day of waxy corn starch. Supplements which come in dry powder form will be mixed in liquid or food for consumption. * filling out a food record and a quality of life questionnaire * keeping a diary of any gi symptoms * collecting samples of blood, spent dialysate, urine(if the patient still makes urine) and stool.

Registry
clinicaltrials.gov
Start Date
July 2010
End Date
September 2015
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • stable dialysis patients able to provide consent.

Exclusion Criteria

  • - known g.i. disease
  • use of antibiotics for the last two month or expected antibiotic use
  • recent hospitalization or other event resulting in instability of food intake

Outcomes

Primary Outcomes

Plasma level of p-cresol sulfate

Time Frame: 8 weeks

Secondary Outcomes

  • Caloric intake(8 weeks)

Study Sites (3)

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