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RECRUITING NA

O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease

NCT06330246 · View on ClinicalTrials.gov ↗

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

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

Sponsor

University of Alabama at Birmingham

1,315 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06330246

The ClinicalTrials.gov registry entry for NCT06330246 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,315 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06330246 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Alabama, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06330246?

This trial is sponsored by University of Alabama at Birmingham, which has 1,315 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial