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NCT06330246 · ClinicalTrials.gov registry record · NA

O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease

A NA study of Kidney Stone and Nephrolithiasis, sponsored by University of Alabama at Birmingham.

Recruiting
Registry status
NA
Development phase
40
Enrollment target
2
Study locations

NCT06330246: Recruiting NA study of Kidney Stone and Nephrolithiasis, sponsored by University of Alabama at Birmingham.

NCT06330246 is a NA study of Kidney Stone and Nephrolithiasis that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 40 participants, below the 191-participant average among 28 other Kidney Stone trials with a reported enrollment target (79% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06330246, a NA study of Kidney Stone and Nephrolithiasis, is actively recruiting participants, sponsored by University of Alabama at Birmingham.

RECRUITING
Registry status
NA
Development phase
40 participants
Enrollment target
2
Study locations

Study 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

Primary Outcome

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

Conditions Studied

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

Interventions

  • 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

Study Locations (2)

Alabama

  • University of Alabama at Birmingham - Birmingham

Texas

  • UTSW - Dallas

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2024-04-17
Est. Completion 2031-12-31
Phase NA
University of Alabama at Birmingham

1,160 total trials

What NCT06330246 shows while recruiting

NCT06330246 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 191-participant average among 28 other Kidney Stone trials with a reported enrollment target (79% lower).

The record links to 8 conditions, with Kidney Stone appearing as the primary indexed condition, and to 5 interventions - of which Low oxalate fixed diets pre-colonization is the first listed.

NCT06330246 reports a single indexed study location in Alabama, Texas.

Frequently Asked Questions

What is clinical trial NCT06330246 about?

NCT06330246 is a clinical study titled "O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease". 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 n...

What is the current status of trial NCT06330246?

This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2024-04-17. Estimated completion is 2031-12-31.

What conditions does trial NCT06330246 study?

This clinical trial studies the following conditions: Kidney Stone, Nephrolithiasis, Urolithiasis, Kidney Calculi, Urolithiasis, Calcium Oxalate.

What interventions are being tested in trial NCT06330246?

The interventions under investigation include: 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 (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT06330246?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06330246 being conducted?

This trial has 2 study locations across Alabama, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Kidney Stone

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06330246's enrollment target sits among peer trials

40 18th of 28 higher than 9 of 28 other Kidney Stone trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Kidney Stone trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06330246

Source: ClinicalTrials.gov NCT06330246, the US trial registry maintained by the National Library of Medicine. NCT06330246 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.