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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK087967 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this research study is to assess the efficacy of ingesting a small amount of the harmless bacterium Oxalobacter formigenes in establishing residence in the guts of healthy participants and to determine whether this influences the oxalate passed in urine.
Adults that are not colonized with O. formigenes, have no history of stone disease, and are in good health as judged by their medical history and a complete metabolic profile of their serum, will be recruited from within the greater Birmingham area.
Participants not colonized with O. formigenes will consume a controlled diet containing moderately high levels of oxalate (210-240 mg per day), and low levels of calcium (500 - 700 mg per day) and collect 24-hour urines to measure oxalate excretion. Following completion of urine collections, participants will ingest live O.formigenes and one week later stool will be provided to test for colonization with O.formigenes. Participants that are successfully colonized with O.formigenes will then repeat 24 hour urine collections on the same high oxalate, low calcium diet. Controlled diets will be prepared in the Metabolic Kitchen of the UAB Clinical Research Unit (CRU). Sustainability of colonization will be determined over time. Loss of colonization will be confirmed by having the subject consume an oxalate-rich meal with subsequent testing for O. formigenes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colonization with Oxalobacter formigenes | Experimental | Subjects not colonized with Oxalobacter formigenes will be equilibrated to a moderately high oxalate/ low calcium oxalate controlled diet and collect 24-hour urines to measure oxalate excretion Subjects will then be colonized with Oxalobacter formigenes(Intervention). Following colonization with Oxalobacter formigenes, urinary oxalate will be measured to determine the impact of colonization on the same controlled diet |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderately high oxalate/low calcium diet non-colonized | Dietary Supplement | Subjects will be instructed to ingest a controlled diet moderately high in oxalate before colonization |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Decrease in Urinary Oxalate Excretion After Colonization With O.Formigenes | Mean 24-hour urine oxalate excretion after colonization with O.formigenes was compared with mean 24-hour urine oxalate before colonization | 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Decrease in Stool Oxalate Content After Colonization With O.Formigenes | Mean stool oxalate content after colonization with O.formigenes was compared with mean stool oxalate before colonization | 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Knight, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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Participants were recruited within the Greater Birmingham area
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| ID | Title | Description |
|---|---|---|
| FG000 | Colonization With Oxalobacter Formigenes | Moderately high oxalate/low calcium diet non-colonized: Participants not colonized with O. formigenes will be instructed to ingest the controlled diet and collect 24-hour urines to measure oxalate excretion Oxalobacter formigenes: Participants will then ingest a live preparation of O. formigenes Moderately high oxalate/low calcium diet colonized: Participants successfully colonized with O. formigenes will be instructed to ingest the same controlled diet consumed prior to colonization |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Colonization With Oxalobacter Formigenes | Moderately high oxalate/low calcium diet non-colonized: Participants not colonized with O.formigenes will collect 24-hour urines on the controlled diet Oxalobacter formigenes: Participants will ingest live preparation of O. formigenes Moderately high oxalate/low calcium diet colonized: Participants successfully colonized with O.formigenes will collect 24-hour urines on the same controlled diet |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Decrease in Urinary Oxalate Excretion After Colonization With O.Formigenes | Mean 24-hour urine oxalate excretion after colonization with O.formigenes was compared with mean 24-hour urine oxalate before colonization | Posted | Mean | Full Range | Percentage decrease in urinary oxalate | 4 days |
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Adverse event data were collected for 4 weeks after ingestion of O.formigenes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Colonization With Oxalobacter Formigenes | Moderately high oxalate/low calcium diet non-colonized: Participants not colonized with O.formigenes will collect 24 urines on the controlled diet Oxalobacter formigenes: Participants will ingest live preparation of O. formigenes Moderately high oxalate/low calcium diet colonized: Participants successfully colonized with O.formigenes will collect 24 urines on the controlled diet |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Knight | University of Alabama at Birmingham | 205-996-2295 | johnknight@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2025 | May 22, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 6, 2021 | May 22, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| C563477 | Nephrolithiasis, Calcium Oxalate |
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Evaluate urinary oxalate excretion before and after colonization with the oxalate degrading bacterium Oxalobacter formigenes
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| Oxalobacter formigenes | Dietary Supplement | Subjects will ingest live preparation of O. formigenes |
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| Moderately high oxalate/low calcium diet colonized | Dietary Supplement | Subjects will be instructed to ingest a controlled diet moderately high in oxalate after colonization |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Mean | Standard Deviation | kg per m2 |
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| Units | Counts |
|---|
| Participants |
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| Secondary | Percentage Decrease in Stool Oxalate Content After Colonization With O.Formigenes | Mean stool oxalate content after colonization with O.formigenes was compared with mean stool oxalate before colonization | Posted | Mean | Full Range | Percentage decrease in stool oxalate | 4 days |
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| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |