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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK137784 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Texas Southwestern Medical Center | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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
In this study the investigators propose to measure the excretion of urinary oxalate on a fixed diet with controlled amounts of oxalate, before and after inducing colonization with the gut bacteria Oxalobacter formigenes in individuals with a history of calcium oxalate kidney stones not already colonized with Oxalobacter formigenes.
Screening and Pre-colonization phase. Between the University of Alabama at Birmingham (UAB) and the University of Texas Southwestern Medical Center (UTSW), the study will enroll 40 individuals with a history of idiopathic calcium oxalate kidney (20 males/20 females). Screening will include stool colonization testing, blood complete metabolic profile, 24-hr urine specimens collected at home on self-selected diets and anthropometric measurements.
Participants will ingest a low-oxalate (<60 mg/day) fixed diet for 4 consecutive days and collect two 24-hr urines and a stool sample after 2 days of dietary equilibration, as well as one fasted blood sample on the last morning.
After a wash-out period of at least 1 week, participants will ingest a moderately high-oxalate (250-300 mg/day) fixed diet for 4 consecutive days and collect two 24-hr urines and a stool sample after 2 days of dietary equilibration, as well as one fasted blood sample on the last morning.
Colonization and Post-colonization phase. Participants will be colonized with Oxalobacter formigenes by ingesting a freshly thawed paste of live bacterial preparation of O. formigenes. They will collect a stool sample 1 week later to assess if colonization occured.
After confirmation of successful colonization, participants will ingest a low-oxalate (<60 mg/day) fixed diet for 4 consecutive days and collect two 24-hr urines and a stool sample after 2 days of dietary equilibration, as well as one fasted blood sample on the last morning.
After a wash-out period of at least 1 week, participants will ingest a moderately high-oxalate (250-300 mg/day) fixed diet for 4 consecutive days and collect two 24-hr urines and a stool sample after 2 days of dietary equilibration, as well as one fasted blood sample on the last morning.
Follow-up phase Participants will be followed up every 6 months to assess sustainability of colonization, provide a stool sample and answer a simple questionnaire. A 24-hr urine collection will be requested once a year after colonization, on the same moderately high oxalate diet diet after 2 days of dietary equilibration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| colonization with Oxalobacter formigenes | Experimental | Colonization with a live preparation of Oxalobacter formigenes, strain OxCC13. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low oxalate fixed diets pre-colonization | Dietary Supplement | 4 days of fixed eucaloric diet with low oxalate (< 60 mg/day), normal calcium (600-1000 mg/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in urinary oxalate excretion following colonization with Oxalobacter formigenes | Difference between urinary oxalate excretion on the moderately high oxalate diet pre-colonization and urinary oxalate excretion on the moderately high oxalate diet post-colonization | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sustainability of colonization with Oxalobacter formigenes | duration of colonization after successful induction of colonization sith Oxalobacter formigenes | 4 years |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sonia Fargue, PhD | Contact | 2059756932 | sfargue@uab.edu | |
| Demond Wiley | Contact | 2059345712 | kidneystone@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sonia Fargue, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35294 | United States |
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| Moderately high oxalate fixed diets pre-colonization | Dietary Supplement | 4 days of fixed eucaloric diet with moderately high oxalate (250-300 mg/day), normal calcium (600-1000 mg/day) |
|
| Colonization with Oxalobacter formigenes | Dietary Supplement | Ingestion of live Oxalobacter formigenes |
|
| Low oxalate fixed diets post-colonization | Dietary Supplement | 4 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 Supplement | 4 days of fixed eucaloric diet with moderately high oxalate (250-300 mg/day), normal calcium (600-1000 mg/day) |
|
| UTSW | Recruiting | Dallas | Texas | 75390 | United States |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D052878 | Urolithiasis |
| C563477 | Nephrolithiasis, Calcium Oxalate |
| D053040 | Nephrolithiasis |
| D006959 | Hyperoxaluria |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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