O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Mar 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether a specific type of gut bacteria, called Oxalobacter formigenes, can help people with calcium oxalate kidney stones by reducing the amount of oxalate in their urine. The researchers want to see if having this bacteria in the gut can make a difference for those who struggle with these types of kidney stones. The study is looking for adults aged 19 to 70 who have a history of calcium oxalate stones and are not currently colonized with Oxalobacter formigenes.

Participants in the trial will follow a set diet for a few days, which will include low and moderately high oxalate foods. They will collect urine, blood, and stool samples during this time. Afterward, they will take a preparation of live Oxalobacter formigenes to try to establish colonization with this bacteria. It’s important for participants to be willing to stop certain supplements and medications for a short period before and during the study. This trial could offer valuable insights into a new way to manage calcium oxalate kidney stones, so if you or someone you know fits the criteria, it might be worth considering participating.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • age 19-70 yrs
• • Body Mass Index \> 18.5 kg/m2
• • First time or recurrent Calcium Oxalate stone former. Composition of most recent stone ≥ 50% calcium oxalate if available
• • Not colonized with Oxalobacter formigenes
• • Normal fasting serum electrolytes on comprehensive metabolic profile
• • Willing to ingest fixed diets
• • Willing to stop supplements (vitamins including vitamin C, calcium (citrate or carbonate) and other minerals, herbal supplements, nutritional aids, probiotics) for 2 weeks before start and during fixed diet phases.
• • If on medications for stone prevention (e.g. thiazides, citrate, allopurinol), stable dose regimen for at least 2 weeks prior to and during study
• • Exclusion Criteria
• • Chronic Kidney Disease stage 4-5
• • Primary hyperoxaluria
• • Liver, endocrine or renal diseases (other than idiopathic Calcium Oxalate kidney stones) or any other condition that may influence the absorption, transport or urinary excretion of ions, which will compromise the interpretation of results, including: Cystic fibrosis, Cystinuria, Uric acid stone former, Nephrotic syndrome, Sarcoidosis, Renal tubular acidosis, Primary hyperparathyroidism, Neurogenic bladder, Urinary diversion
• • Pregnancy or breast-feeding
• • Incompatible dietary requirements with the study, food allergies or intolerance to any of the foods in study menus
• • Active malignancy or treatment for malignancy within 12 months prior to screening
• • Utilization of immunosuppressive medication
• • Uncontrolled Hypertension or diabetes
• • Diabetes type 1
• • Current Colonization with Oxalobacter formigenes