O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- University of Alabama at Birmingham
- Study ID
- NCT06330246
- Status
- Recruiting
Conditions
- Kidney Calculi
- Kidney Stone
- Nephrolithiasis
- Nephrolithiasis, Calcium Oxalate
- Oxalate Urolithiasis
- Oxaluria
- Urolithiasis
- Urolithiasis, Calcium Oxalate
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Low oxalate fixed diets pre-colonization — DIETARY_SUPPLEMENT4 days of fixed eucaloric diet with low oxalate (\< 60 mg/day), normal calcium (600-1000 mg/day)
- Moderately high oxalate fixed diets pre-colonization — DIETARY_SUPPLEMENT4 days of fixed eucaloric diet with moderately high oxalate (250-300 mg/day), normal calcium (600-1000 mg/day)
- Colonization with Oxalobacter formigenes — DIETARY_SUPPLEMENTIngestion of live Oxalobacter formigenes
- Low oxalate fixed diets post-colonization — DIETARY_SUPPLEMENT4 days of fixed eucaloric diet with low oxalate (\< 60 mg/day), normal calcium (600-1000 mg/day)
- Moderately high oxalate fixed diets post-colonization — DIETARY_SUPPLEMENT4 days of fixed eucaloric diet with moderately high oxalate (250-300 mg/day), normal calcium (600-1000 mg/day)
Study Details
The goal of this trial is to test if colonization with the gut bacteria Oxalobacter formigenes leads to a reduction in urinary oxalate excretion in patients with calcium oxalate kidney stone disease. The study will recruit adult participants with a history of calcium oxalate kidney stones who are not colonized with Oxalobacter formigenes. Participants will * ingest fixed diets containing low and moderately high amounts of oxalate for 4 days at a time * collect urine, blood and stool samples during the fixed diets * ingest a preparation of live Oxalobacter formigenes to induce colonization with Oxalobacter formigenes
Key Dates
- Start date
- Apr 17, 2024
- Status verified
- May 2026
- Primary completion
- Dec 31, 2030
- Completion
- Dec 31, 2031
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: colonization with Oxalobacter formigenesColonization with a live preparation of Oxalobacter formigenes, strain OxCC13.
Primary Outcome Measure
Change in urinary oxalate excretion following colonization with Oxalobacter formigenes [ Time Frame: 2 months ]
Central Contacts
- Sonia Fargue, PhD2059756932
- Demond Wiley2059345712
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | Sonia Fargue, PhD (PRINCIPAL_INVESTIGATOR) |
| UTSW | Dallas | Texas | 75390 | Naim Maalouf, MD Esperanza Jackson Naim Maalouf, MD (PRINCIPAL_INVESTIGATOR) |
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