O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease

NCT06330246 | Recruiting DMC

• 2 other identifiers: IRB300005280-OCKR01DK137784
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Kidney Stone; Kidney Calculi; Urolithiasis; Urolithiasis, Calcium Oxalate; Nephrolithiasis; Nephrolithiasis, Calcium Oxalate; Oxalate Urolithiasis; Oxaluria

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Sustainability of colonization with Oxalobacter formigenes

  4 years

Study Arms (1)

colonization with Oxalobacter formigenes

EXPERIMENTAL

Colonization with a live preparation of Oxalobacter formigenes, strain OxCC13.

Dietary Supplement: Low oxalate fixed diets pre-colonization; Dietary Supplement: Moderately high oxalate fixed diets pre-colonization; Dietary Supplement: Colonization with Oxalobacter formigenes; Dietary Supplement: Low oxalate fixed diets post-colonization; Dietary Supplement: Moderately high oxalate fixed diets post-colonization

Interventions

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)

colonization with Oxalobacter formigenes

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

Colonization with Oxalobacter formigenes DIETARY_SUPPLEMENT

Ingestion of live Oxalobacter formigenes

colonization with 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)

colonization with Oxalobacter formigenes

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)

colonization with Oxalobacter formigenes

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• University of Texas Southwestern Medical Center: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

UTSW

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Kidney Calculi; Urolithiasis; Nephrolithiasis, Calcium Oxalate; Nephrolithiasis; Hyperoxaluria

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Sonia Fargue, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonia Fargue, PhD

CONTACT

2059756932; sfargue@uab.edu

Demond Wiley

CONTACT

2059345712; kidneystone@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: April 17, 2024
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)