Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes
2 other identifiers
interventional
58
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2010
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 19, 2010
CompletedFirst Posted
Study publicly available on registry
August 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedAugust 25, 2022
August 1, 2022
5.2 years
August 19, 2010
August 22, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Plasma level of p-cresol sulfate
8 weeks
Secondary Outcomes (1)
Caloric intake
8 weeks
Study Arms (2)
Corn Starch
PLACEBO COMPARATORCorn starch will serve as the control arm.
Fiber
EXPERIMENTALFiber will serve as the intervention.
Interventions
Corn starch to be consumed daily for 6 weeks. This will serve as the control/placebo arm.
Eligibility Criteria
You may qualify if:
- stable dialysis patients able to provide consent.
You may not qualify if:
- use of antibiotics for the last two month or expected antibiotic use
- recent hospitalization or other event resulting in instability of food intake
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- National Institutes of Health (NIH)collaborator
Study Sites (3)
VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
Satellite Dialysis
Redwood City, California, 94063, United States
SCVMC
San Jose, California, 95128, United States
Related Publications (1)
Cooper TE, Khalid R, Chan S, Craig JC, Hawley CM, Howell M, Johnson DW, Jaure A, Teixeira-Pinto A, Wong G. Synbiotics, prebiotics and probiotics for people with chronic kidney disease. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD013631. doi: 10.1002/14651858.CD013631.pub2.
PMID: 37870148DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy W Meyer
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2010
First Posted
August 23, 2010
Study Start
July 1, 2010
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
August 25, 2022
Record last verified: 2022-08