RECRUITING

O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Oxalobacter Formigenes Colonization in Calcium Oxalate Kidney Stone Formers

Quick Facts

Study Start:2024-04-17
Study Completion:2031-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06330246

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Sonia Fargue, PhD
CONTACT
2059756932
sfargue@uab.edu
Demond Wiley
CONTACT
2059345712
kidneystone@uabmc.edu

Principal Investigator

Sonia Fargue, PhD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
UTSW
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Sonia Fargue, PhD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2024-04-17
Study Completion Date2031-12-31

Study Record Updates

Study Start Date2024-04-17
Study Completion Date2031-12-31

Terms related to this study

Additional Relevant MeSH Terms

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