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Oxalobacter Formigenes Colonization and Urinary Oxalate Excretion

Primary Purpose

Calcium Oxalate Urolithiasis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Oxalate Diet
Moderately high oxalate/low calcium diet
Oxalobacter formigenes
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Calcium Oxalate Urolithiasis focused on measuring Oxalobacter formigenes, oxalate, kidney stones

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Low Oxalate Diet

Moderately high oxalate/low calcium diet

Oxalobacter formigenes

Arm Description

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.

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.

Subjects will ingest a live preparation of O.formigenes

Outcomes

Primary Outcome Measures

Measurement of urinary oxalate by ion chromatography mass spectrometry
1st 24 hour urine collection, started 24 hours after initiation of controlled diet
Measurement of urinary oxalate by ion chromatography mass spectrometry
48 hours post diet
Measurement of urinary oxalate by ion chromatography mass spectrometry
72 hours post diet
Measurement of urinary oxalate by ion chromatography mass spectrometry
96 hours post diet

Secondary Outcome Measures

Measurement of stool oxalate by ion chromatography mass spectrometry
First bowel movement collected during days 2 through 4 of dietary control
Measurement of stool oxalate by ion chromatography mass spectrometry
Second bowel movement collected during days 2 through 4 of dietary control
Measurement of stool oxalate by ion chromatography mass spectrometry
Third bowel movement collected during days 2 through 4 of dietary control

Full Information

First Posted
October 22, 2018
Last Updated
July 17, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03752684
Brief Title
Oxalobacter Formigenes Colonization and Urinary Oxalate Excretion
Official Title
Oxalobacter Formigenes Colonization and Oxalate Excretion in Calcium Oxalate Kidney Stone Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2, 2018 (Actual)
Primary Completion Date
April 27, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcium Oxalate Urolithiasis
Keywords
Oxalobacter formigenes, oxalate, kidney stones

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Evaluate urinary oxalate excretion before and after colonization with the oxalate degrading bacterium Oxalobacter formigenes
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Oxalate Diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Moderately high oxalate/low calcium diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Oxalobacter formigenes
Arm Type
Experimental
Arm Description
Subjects will ingest a live preparation of O.formigenes
Intervention Type
Other
Intervention Name(s)
Low Oxalate Diet
Intervention Description
Subjects will be instructed to ingest a controlled diet low in oxalate
Intervention Type
Other
Intervention Name(s)
Moderately high oxalate/low calcium diet
Intervention Description
Subjects will be instructed to ingest a controlled diet moderately high in oxalate
Intervention Type
Other
Intervention Name(s)
Oxalobacter formigenes
Intervention Description
Subjects will ingest live preparation of O. formigenes
Primary Outcome Measure Information:
Title
Measurement of urinary oxalate by ion chromatography mass spectrometry
Description
1st 24 hour urine collection, started 24 hours after initiation of controlled diet
Time Frame
1st 24 hour collection
Title
Measurement of urinary oxalate by ion chromatography mass spectrometry
Description
48 hours post diet
Time Frame
2nd 24 hour collection
Title
Measurement of urinary oxalate by ion chromatography mass spectrometry
Description
72 hours post diet
Time Frame
3rd 24 hour collection
Title
Measurement of urinary oxalate by ion chromatography mass spectrometry
Description
96 hours post diet
Time Frame
4th 24 hour urine collection
Secondary Outcome Measure Information:
Title
Measurement of stool oxalate by ion chromatography mass spectrometry
Description
First bowel movement collected during days 2 through 4 of dietary control
Time Frame
Stool collected 48-96 hours post diet
Title
Measurement of stool oxalate by ion chromatography mass spectrometry
Description
Second bowel movement collected during days 2 through 4 of dietary control
Time Frame
Stool collected 48-96 hours post diet
Title
Measurement of stool oxalate by ion chromatography mass spectrometry
Description
Third bowel movement collected during days 2 through 4 of dietary control
Time Frame
Stool collected 48-96 hours post diet

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Knight, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Oxalobacter Formigenes Colonization and Urinary Oxalate Excretion

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