Status:

RECRUITING

GI Oxalate Absorption

Lead Sponsor:

University of Chicago

Collaborating Sponsors:

University of Alabama at Birmingham

Conditions:

Bariatric Surgery Candidate

Kidney Stone

Eligibility:

All Genders

18-70 years

Phase:

NA

Brief Summary

This study aims to learn more about how oxalate, a compound found in many foods, may affect a person's chances of forming kidney stones. Active participation in this study will last for around one wee...

Detailed Description

The study will be carried out in the University of Chicago Medicine (UCM) Clinical Research Center (CRC). Study Population and Recruitment Enroll 10 post-Roux-en-Y Gastric Bypass stone forming, 10 ob...

Eligibility Criteria

Inclusion

  • Post-Roux-en-Y gastric bypass stone formers:
  • Age 18-70
  • Previous history of Roux-en-Y gastric bypass
  • History of at least one calcium-based kidney stone after surgery
  • Pre-protocol urine oxalate above the lab normal range (50mg/day)
  • Obese stone formers:
  • Age 18-70
  • Body mass index (BMI) \>=30kg/m2
  • History of at least one calcium-based kidney stone
  • Pre-protocol urine oxalate above the lab normal range (50mg/day)
  • Non-obese stone formers:
  • Age 18-70, BMI between 18.5-29.9 kg/m2
  • History of at least one calcium-based kidney stone

Exclusion

  • Post-Roux-en-Y gastric bypass stone formers:
  • History of colon resection (partial or complete)
  • History of duodenal switch bowel surgery
  • History of ileal-jejunal bypass surgery
  • History of primarily uric acid, cysteine, or struvite stones
  • Obese and non-obese stone formers:
  • History of bowel surgery
  • History of colon resection
  • History of inflammatory bowel disease (Crohn's disease, Ulcerative Colitis)
  • History of primarily uric acid, cysteine, or struvite stones

Key Trial Info

Start Date :

January 25 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 2 2026

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT05356000

Start Date

January 25 2023

End Date

August 2 2026

Last Update

August 19 2025

Active Locations (1)

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1

University of Chicago Medical Center

Chicago, Illinois, United States, 60637