protocolSection identificationModule nctId: NCT06330246, orgStudyIdInfo id: IRB300005280, secondaryIdInfos id: R01DK137784, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DK137784, briefTitle: O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2030-12-31, completionDateStruct date: 2031-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, collaborators name: University of Texas Southwestern Medical Center, collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), descriptionModule briefSummary: 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, conditionsModule conditions: Kidney Stone, conditions: Kidney Calculi, conditions: Urolithiasis, conditions: Urolithiasis, Calcium Oxalate, conditions: Nephrolithiasis, conditions: Nephrolithiasis, Calcium Oxalate, conditions: Oxalate Urolithiasis, conditions: Oxaluria, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Low oxalate fixed diets pre-colonization, interventions name: Moderately high oxalate fixed diets pre-colonization, interventions name: Colonization with Oxalobacter formigenes, interventions name: Low oxalate fixed diets post-colonization, interventions name: Moderately high oxalate fixed diets post-colonization, outcomesModule primaryOutcomes measure: Change in urinary oxalate excretion following colonization with Oxalobacter formigenes, secondaryOutcomes measure: Sustainability of colonization with Oxalobacter formigenes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama at Birmingham, status: RECRUITING, city: Birmingham, state: Alabama, zip: 35294, country: United States, contacts name: Sonia Fargue, PhD, role: CONTACT, phone: 205-975-6932, email: sfargue@uab.edu, contacts name: Research Coordinator, role: CONTACT, phone: 2059345712, email: kidneystone@uabmc.edu, contacts name: Sonia Fargue, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, locations facility: UTSW, status: RECRUITING, city: Dallas, state: Texas, zip: 75390, country: United States, contacts name: Naim Maalouf, MD, role: CONTACT, email: Naim.Maalouf@UTSouthwestern.edu, contacts name: Esperanza Jackson, role: CONTACT, email: Esperanza.Jackson@UTSouthwestern.edu, contacts name: Naim Maalouf, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False