Expired Study
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Rochester, Minnesota 55905


Purpose:

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).


Study summary:

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.


Criteria:

Inclusion Criteria: - Enteric hyperoxaluria (>0.5 mM/day; > 45 mg/day) due to fat malabsorption from inflammatory bowel disease (Crohn's Disease, CD) (n=30) (patients in remission maintained on stable doses of Remecade/Imuran/Methotrexate every 8 weeks can be recruited as long as the trial can be conducted between 5 and 8 weeks after the last dose); OR - Enteric hyperoxaluria (>0.5 mM/day; > 45 mg/day) from gastric bypass procedures (gastric bypass for obesity, or other surgical causes of gastric dumping and fat malabsorption (e.g., antrectomy, vagotomy and pyloroplasty for gastric ulcers)(n=30) (patients with inflammatory bowel disease must be in clinical remission); OR - Calcium oxalate nephrolithiasis and mild hyperoxaluria of unknown etiology (>0.35 mM/day) (n=60) - Presence of radioopaque stones on x-ray, or a history consistent with passage of a stone or stone surgery or ESWL in the last 5 years and if on stone medication, doses have remained stable for at least 3 months - Stone composition confirmed either by stone analysis demonstrating composition equal to or more than 50% calcium oxalate, or by radiographic demonstration of a calcific renal stone in the presence of hyperoxaluria Exclusion Criteria: - On immunosuppressive medications (excluding small stable doses of prednisone of 10 mg or less) - HIV infection, known enteric bacterial infection, or history of splenectomy - Have a current malignancy, other than superficial skin cancers that have been excised, unless they felt to be in complete remission (> 5 years)21 - Previous colectomy - Have completed a course of oral or parenteral antibiotics less than 2 weeks before initiation of the study (patients who require a course of antibiotics during the period of preparation administration will be withdrawn from the study and excluded from the final analysis) - Patient pregnant or breast-feeding


NCT ID:

NCT00587041


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Rochester, Minnesota 55905
United States

Ruth Kraft
Phone: 507-284-9262
Email: kraft.ruth@mayo.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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