Oxalobacter Formigenes Colonization and Urinary Oxalate Excretion

Calcium Oxalate Urolithiasis Clinical Trial

Official title:

Oxalobacter Formigenes Colonization and Oxalate Excretion in Calcium Oxalate Kidney Stone Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03752684
• Other study ID #: IRB-131212001
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 human subjects and to determine whether this influences the oxalate passed in urine of healthy volunteers.

Description:

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, a complete metabolic profile of their serum, and ranges of ions that influence stone formation in two 24-hour urine collections, will be recruited from within the greater Birmingham area. Recruited subjects will be between the ages of 18 to 65 years and with a BMI >19 and <32.

Subjects not colonized with O. formigenes will consume, firstly, a controlled diet containing 50 mg oxalate and 1000mg calcium (low oxalate/normal calcium diet), followed by a 250 mg oxalate/400mg calcium controlled diet (moderately high oxalate/low calcium diet), with at least a one week washout between each diet, and then repeat the same sequence of diets after colonization with O.formigenes Group 1 strain OxCC13. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 23
• Est. completion date: December 31, 2024
• Est. primary completion date: April 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

• Good health as judged from a medical history and reported medications

• Not colonized with O. formigenes

Exclusion Criteria:

• History of any hepatic, renal, bowel or endocrine disease or any other condition that may influence the absorption, transport or urinary excretion of ions, which will compromise the interpretation of results

• colonized with O. formigenes

• abnormal urine chemistries or blood metabolic profiles

Related Conditions & MeSH terms

• Calcium Oxalate Urolithiasis
• Urolithiasis

Intervention

Other:
• Low Oxalate Diet
Subjects will be instructed to ingest a controlled diet low in oxalate
• Moderately high oxalate/low calcium diet
Subjects will be instructed to ingest a controlled diet moderately high in oxalate
• Oxalobacter formigenes
Subjects will ingest live preparation of O. formigenes

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of urinary oxalate by ion chromatography mass spectrometry	1st 24 hour urine collection, started 24 hours after initiation of controlled diet	1st 24 hour collection
Primary	Measurement of urinary oxalate by ion chromatography mass spectrometry	48 hours post diet	2nd 24 hour collection
Primary	Measurement of urinary oxalate by ion chromatography mass spectrometry	72 hours post diet	3rd 24 hour collection
Primary	Measurement of urinary oxalate by ion chromatography mass spectrometry	96 hours post diet	4th 24 hour urine collection
Secondary	Measurement of stool oxalate by ion chromatography mass spectrometry	First bowel movement collected during days 2 through 4 of dietary control	Stool collected 48-96 hours post diet
Secondary	Measurement of stool oxalate by ion chromatography mass spectrometry	Second bowel movement collected during days 2 through 4 of dietary control	Stool collected 48-96 hours post diet
Secondary	Measurement of stool oxalate by ion chromatography mass spectrometry	Third bowel movement collected during days 2 through 4 of dietary control	Stool collected 48-96 hours post diet