Use of Oral Probiotics to Reduce Urinary Oxalate Excretion
NCT00587041 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2012-05-31
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
- Nephrolithiasis
- Hyperoxaluria
- Crohn's Disease
Interventions
- DIETARY_SUPPLEMENT
-
Oxadrop
Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis).
- DIETARY_SUPPLEMENT
-
Agri-King Synbiotic (AKSB)
AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
- OTHER
-
Placebo
1 placebo packet daily and 1 placebo capsule twice daily
Sponsors & Collaborators
-
National Institutes of Health (NIH)
collaborator NIH -
National Center for Complementary and Integrative Health (NCCIH)
collaborator NIH -
National Center for Research Resources (NCRR)
collaborator NIH -
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
collaborator NIH - lead OTHER
Principal Investigators
-
John C Lieske, MD · Mayo Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-02-28
- Primary Completion
- 2009-07-31
- Completion
- 2009-07-31
Countries
- United States
Study Locations
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