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Sponsors and Collaborators: |
Mayo Clinic National Institutes of Health (NIH) |
Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00587041 |
Aim # 1: Determine the effect of two probiotic preparations (AKSB and Oxadrop) on urinary oxalate excretion in two well-defined groups of patients with enteric hyperoxaluria.
Our hypothesis is that the probiotics will improve gastrointestinal barrier function, and thereby decrease oxalate absorption from the gut (and hence its elimination in the urine). An important component of this study is the use of a controlled diet ducting the urinary oxalate determinations, in order to remove the potential confounding variable of dietary oxalate intake and availability from food. fined groups of patients with enteric hyperoxaluria.
Aim # 2: Determine the effect of two probiotic preparations (AKSB and Oxadrop®) on urinary oxalate excretion in a well-defined group of patients with idiopathic calcium oxalate urolithiasis and mild hyperoxaluria.
Our hypothesis is that the mild hyperoxaluria is due to overabsorption 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).
Condition | Intervention | Phase |
Enteric Hyperoxaluria Crohn's Disease Gastric Bypass |
Drug: Oxadrop/Placebo Drug: AKSB/Placebo Other: Placebo/Placebo |
Phase I Phase II |
Genetics Home Reference related topics: | Crohn disease |
MedlinePlus related topics: | Crohn's Disease |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Use of Symbiotics to Reduce Urinary Oxalate Excretion |
Estimated Enrollment: | 120 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Placebo Comparator |
Drug: Oxadrop/Placebo
Take one packet by mouth twice a day for 5 weeks. Take one capsule by mouth twice a day for 5 weeks.
Drug: AKSB/Placebo
Take one capsule by mouth twice a day for 5 weeks Take one packet by mouth twice a day for 5 weeks
Other: Placebo/Placebo
Take one capsule by mouth every day for 5 weeks. Take one packet by mouth every day for 5 weeks.
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Renal manifestations of chronic hyperoxaluria include nephrolithiasis and, when extreme, interstitial scarring and progressive loss of function. The clinical outcome can be dismal. Although primary hyperoxaluria is relatively rare, hyperoxaluria secondary to gastrointestinal malabsorption is not. Furthermore, the formation of calcium oxalate kidney stones is extremely common, and evidence suggests that minimal, perhaps transient elevations in urinary oxalate concentration may be an important factor in at least a subgroup of these patients with "idiopathic" calcium oxalate urolithiasis. In the case of enteric hyperoxaluria the pathogenic role of oxalate is clear, and renal scarring is commonly observed as a consequence of oxalate exposure and calcium oxalate crystal deposition, in addition to stones. Unfortunately, few satisfactory specific treatments for enteric hyperoxaluria are available. Typical strategies include dietary restriction of oxalate to limit its delivery to the colon; low fat diets to limit malabsorption and distal colonic effects of fatty acids and bile acids; oral calcium to bind oxalate; and bile acid sequestrants like cholestyramine. In its entirety, this regimen is quite rigorous for patients, and even if compliance is achieved the therapy is not always effective. Previous studies have shown that components of the endogenous digestive microflora can utilize oxalate, potentially limiting its absorption from the intestinal lumen. A recent preliminary study demonstrated that a preparation of lactic acid bacteria degraded oxalate in vitro and reduced urinary oxalate excretion when given by mouth. We have recently demonstrated that the same preparation of lactic acid bacilli (Oxadrop) can reduce urinary oxalate excretion in patients with enteric hyperoxaluria. In the current proposal, in a placebo-controlled trial we will determine the effectiveness of this and another probiotic preparation (AKSB) for the treatment of hyperoxaluria in patients with mild hyperoxaluria, as well as enteric hyperoxaluria. Specific Aims are: 1) Determine the effect of two probiotic preparations (AKSB and Oxadrop on urinary oxalate excretion in a well-defined group of patients with enteric hyperoxaluria; and 2) Determine the effect of two probiotic preparations (AKSB and Oxadrop) on urinary oxalate excretion in a well-defined group of patients with idiopathic calcium oxalate urolithiasis and mild hyperoxaluria. If results are positive, treatment for calcium oxalate kidney stones could be revolutionized.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Minnesota | |||||
Mayo Clinic | Recruiting | ||||
Rochester, Minnesota, United States, 55905 | |||||
Contact: Ruth Kraft 507-284-9262 kraft.ruth@mayo.edu | |||||
Principal Investigator: John C Lieske |
Mayo Clinic |
National Institutes of Health (NIH) |
Mayo Clinic Clinical Trials 
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Responsible Party: | Mayo Clinic Rochester ( Dr. John Lieske ) |
Study ID Numbers: | 1483-05, AT002534 |
First Received: | December 21, 2007 |
Last Updated: | September 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00587041 |
Health Authority: | United States: Institutional Review Board |
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