Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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 2,414-participant average among 104 other Crohn's Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00587041
The ClinicalTrials.gov registry entry for NCT00587041 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,414-participant average among 104 other Crohn's Disease trials with a reported enrollment target (98% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
Similar trials for Crohn's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Autologous Stem Cell Transplantation for Crohn's Disease
RECRUITING · Phase 1
-
An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab
RECRUITING · Phase 1
-
Beta-Hydroxybutyrate Feasibility Treating IBD
RECRUITING · Phase 1
-
Treatment of Moderate to Severe Refractory Crohn's Disease
RECRUITING · Phase 1
-
Study to Evaluate Safety, Tolerability and Efficacy of Oral E-B-FAHF-2 in Mild-to-Moderate Crohn's Disease
ACTIVE NOT RECRUITING · Phase 1
-
Single Ascending Dose Study of Oral CPSI-2364 (Semapimod)
COMPLETED · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.