Oxalobacter Formigenes Colonization and Urinary Oxalate Excretion

December 21, 2023 updated by: John Knight, University of Alabama at Birmingham

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Oxalate Diet

Subjects not colonized with Oxalobacter formigenes will be equilibrated to a low oxalate diet to determine baseline oxalate values in urine .

Subjects will be colonized with Oxalobacter formigenes (Intervention). Following colonization with Oxalobacter formigenes, urinary oxalate will be measured to determine the impact of colonization.
Other: Low Oxalate Diet
Subjects will be instructed to ingest a controlled diet low in oxalate
Experimental: Moderately high oxalate/low calcium diet

Subjects not colonized with Oxalobacter formigenes will be equilibrated to a moderately high oxalate/ low calcium oxalate diet to enhance dietary oxalate absorption.

Subjects will be colonized with Oxalobacter formigenes(Intervention). Following colonization with Oxalobacter formigenes, urinary oxalate will be measured to determine the impact of colonization.
Other: Moderately high oxalate/low calcium diet
Subjects will be instructed to ingest a controlled diet moderately high in oxalate
Experimental: Oxalobacter formigenes
Subjects will ingest a live preparation of O.formigenes
Other: Oxalobacter formigenes
Subjects will ingest live preparation of O. formigenes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of urinary oxalate by ion chromatography mass spectrometry
Time Frame: 1st 24 hour collection
1st 24 hour urine collection, started 24 hours after initiation of controlled diet
1st 24 hour collection
Measurement of urinary oxalate by ion chromatography mass spectrometry
Time Frame: 2nd 24 hour collection
48 hours post diet
2nd 24 hour collection
Measurement of urinary oxalate by ion chromatography mass spectrometry
Time Frame: 3rd 24 hour collection
72 hours post diet
3rd 24 hour collection
Measurement of urinary oxalate by ion chromatography mass spectrometry
Time Frame: 4th 24 hour urine collection
96 hours post diet
4th 24 hour urine collection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of stool oxalate by ion chromatography mass spectrometry
Time Frame: Stool collected 48-96 hours post diet
First bowel movement collected during days 2 through 4 of dietary control
Stool collected 48-96 hours post diet
Measurement of stool oxalate by ion chromatography mass spectrometry
Time Frame: Stool collected 48-96 hours post diet
Second bowel movement collected during days 2 through 4 of dietary control
Stool collected 48-96 hours post diet
Measurement of stool oxalate by ion chromatography mass spectrometry
Time Frame: Stool collected 48-96 hours post diet
Third bowel movement collected during days 2 through 4 of dietary control
Stool collected 48-96 hours post diet

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: John Knight, PhD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2018

Primary Completion (Actual)

April 27, 2023

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

October 22, 2018

First Submitted That Met QC Criteria

November 21, 2018

First Posted (Actual)

November 26, 2018

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-131212001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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