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Completed

NCT Number: NCT03752684

Oxalobacter Formigenes Colonization and Urinary Oxalate Excretion

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 healthy participants and to determine whether this influences the oxalate passed in urine.

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Key information

About this study

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 and a complete metabolic profile of their serum, will be recruited from within the greater Birmingham area.

Participants not colonized with O. formigenes will consume a controlled diet containing moderately high levels of oxalate (210-240 mg per day), and low levels of calcium (500 - 700 mg per day) and collect 24-hour urines to measure oxalate excretion. Following completion of urine collections, participants will ingest live O.formigenes and one week later stool will be provided to test for colonization with O.formigenes. Participants that are successfully colonized with O.formigenes will then repeat 24 hour urine collections on the same high oxalate, low calcium diet. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moderately high oxalate/low calcium diet non-colonized

Dietary Supplement

Subjects will be instructed to ingest a controlled diet moderately high in oxalate before colonization

Oxalobacter formigenes

Dietary Supplement

Subjects will ingest live preparation of O. formigenes

Moderately high oxalate/low calcium diet colonized

Dietary Supplement

Subjects will be instructed to ingest a controlled diet moderately high in oxalate after colonization

Primary outcomes

  1. Percent Decrease in Urinary Oxalate Excretion After Colonization With O.Formigenes

    Time frame: 4 days

    Mean 24-hour urine oxalate excretion after colonization with O.formigenes was compared with mean 24-hour urine oxalate before colonization

Secondary outcomes

  1. Percentage Decrease in Stool Oxalate Content After Colonization With O.Formigenes

    Time frame: 4 days

    Mean stool oxalate content after colonization with O.formigenes was compared with mean stool oxalate before colonization

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Oxalobacter Formigenes Colonization and Oxalate Excretion in Healthy Adults

Important dates

Study start
2018
Primary completion
2023
Study completion
2025
First posted
Nov 26, 2018
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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