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NCT00587041 · ClinicalTrials.gov registry record · Phase 1
Use of Oral Probiotics to Reduce Urinary Oxalate Excretion
A Phase 1 study of Crohn's Disease and Nephrolithiasis, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT00587041: Completed Phase 1 study of Crohn's Disease and Nephrolithiasis, sponsored by Mayo Clinic.
NCT00587041 is a Phase 1 study of Crohn's Disease and Nephrolithiasis that has completed, run by Mayo Clinic. The registered enrollment target is 40 participants, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00587041, a Phase 1 study of Crohn's Disease and Nephrolithiasis, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study was to determine the effect of two probiotic preparations (Agri-King Synbiotic and Oxadrop) on urinary oxalate excretion in patients with mild hyperoxaluria. Probiotics are live microorganisms thought to be beneficial to the host organism. Hyperoxaluria is a hereditary disorder that causes a special kind of stone to form in the kidney and urine. Oxalates are naturally-occurring substances found in plants, animals, and in humans. Excretion of oxalates in the urine is a risk factor for kidney stone formation. Our hypothesis was that the mild hyperoxaluria is due to over absorption of oxalate from food and that probiotics will improve gastrointestinal barrier function to decrease oxalate absorption across the gut (and hence its elimination in the urine). In the study, participants were randomized to placebo, Agri-King Synbiotic, or Oxadrop, and were treated for 6 weeks. Patients were maintained on a controlled diet to remove the confounding variable of differing oxalate intake and availability from food.
Primary Outcome
Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phase
Conditions Studied
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT Oxadrop
- DIETARY_SUPPLEMENT Agri-King Synbiotic (AKSB)
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2006-02 |
| Est. Completion | 2009-07 |
| Phase | Phase 1 |
What the finished NCT00587041 record still lists
NCT00587041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Crohn's Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00587041 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT00587041 about?
NCT00587041 is a clinical study titled "Use of Oral Probiotics to Reduce Urinary Oxalate Excretion". The purpose of this study was to determine the effect of two probiotic preparations (Agri-King Synbiotic and Oxadrop) on urinary oxalate excretion in patients with mild hyperoxaluria. Probiotics are live microorganisms thought to be beneficial to the host organism. Hyperoxaluria is a hereditary diso...
What is the current status of trial NCT00587041?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2006-02. Estimated completion is 2009-07.
What conditions does trial NCT00587041 study?
This clinical trial studies the following conditions: Crohn's Disease, Nephrolithiasis, Hyperoxaluria.
What interventions are being tested in trial NCT00587041?
The interventions under investigation include: Placebo (OTHER), Oxadrop (DIETARY_SUPPLEMENT), Agri-King Synbiotic (AKSB) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00587041?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00587041 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00587041's enrollment target sits among peer trials
40 86th of 105 higher than 18 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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