Kidney Failure, ChronicNCT01186276
Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes
A study testing Fiber and Corn starch in people with Kidney Failure, Chronic, run by Stanford University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Fiber and Corn starch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2010to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable dialysis patients able to provide consent.
Who cannot join
- use of antibiotics for the last two month or expected antibiotic use
- recent hospitalization or other event resulting in instability of food intake
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Palo Alto Health Care System
Palo Alto, California, 94304
Satellite Dialysis
Redwood City, California, 94063
SCVMC
San Jose, California, 95128
About this study
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.
Read the 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.
- Conditions
- Kidney Failure, Chronic
- Being tested
- Fiber, Corn starch
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FiberDietary supplement
Dietary fiber supplements to be consumed daily for 6 weeks.
Corn starchDietary supplement
Corn starch to be consumed daily for 6 weeks. This will serve as the control/placebo arm.
| Study group | Role | What they receive |
|---|---|---|
| Corn Starch | Placebo comparator | Corn starch will serve as the control arm. Receives: Dietary Supplement: Corn starch |
| Fiber | Experimental | Fiber will serve as the intervention. Receives: Dietary Supplement: Fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma level of p-cresol sulfate
Measured: 8 weeks
Secondary outcomes (1)
Caloric intake
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Timothy W Meyer, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186276
- Sponsor's protocol ID
- SU-07292010-6626
- Other IDs
- NIH R21AT005123-01A1
- Status last verified
- Aug 2022
- First submitted
- 19 Aug 2010
- Last updated
- 25 Aug 2022
- Results posted
- No
Publications
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.
PubMed 37870148
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes
- ClinicalTrials.gov ID
- NCT01186276
- Acronym / sponsor ID
- SU-07292010-6626
- Conditions
- Kidney Failure, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 2010 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 23 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corn Starch | Placebo comparator | Dietary Supplement: Corn starchCorn starch will serve as the control arm. |
| Fiber | Experimental | Dietary Supplement: FiberFiber will serve as the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- stable dialysis patients able to provide consent.
Key exclusion criteria (2 listed)
- use of antibiotics for the last two month or expected antibiotic use
- recent hospitalization or other event resulting in instability of food intake
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FiberDietary fiber supplements to be consumed daily for 6 weeks. | Dietary supplement | Fiber |
| Corn starchCorn starch to be consumed daily for 6 weeks. This will serve as the control/placebo arm. | Dietary supplement | Corn Starch |
Primary outcome
Plasma level of p-cresol sulfate
Time frame: 8 weeks
1 secondary outcome
Caloric intake
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Derived from this study: PubMed 37870148Cooper 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy W Meyer principal investigator
Stanford University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fiber and Corn starch in people with Kidney Failure, Chronic, run by Stanford University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma level of p-cresol sulfate (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01186276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.