Investigating gut microbiota's role in kidney stones
Effect of Control in Oxalate and Citrate Intake on Gut Microbiota Composition in Patients With Urolithiasis: Double-blind Randomized Clinical Study
This study is testing how different diets can affect gut bacteria and help people with kidney stones in Mexico feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Hospital Regional de Alta Especialidad de la Península de Yucatán Academic / other |
| Locations | 1 site (Mérida, Yucatán) |
| Trial ID | NCT05511337 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on patients with urolithiasis, commonly known as kidney stones, in Yucatan, Mexico. It is a double-blind randomized study where participants are divided into three groups for 28 days: a control group with caloric restriction, an intervention group with caloric restriction and dietary modifications to reduce oxalate intake while increasing citrate intake, and a real-life intervention group without caloric restriction but with similar dietary modifications. The study aims to assess the impact of these dietary changes on the gut microbiota and related metabolic processes. Measurements such as anthropometric data and urine and blood samples will be collected to evaluate the effects of the interventions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with a confirmed diagnosis of urolithiasis and a BMI between 25 and 39.9.
Not a fit: Patients with chronic kidney disease, type 2 diabetes, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary modifications that may help prevent kidney stone formation.
How similar studies have performed: While there is emerging research on the role of gut microbiota in various conditions, this specific approach to urolithiasis is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Subjects living in Merida, Yucatan * Female or male * Age between 18 and 60 years * Confirmed diagnosis of UL confirmed with ultrasound (≥5mm) and/or radiographs or who had expelled a stone in a time no longer than 7 days at the time of selection * BMI ≥ 25 and ≤ 39.9 kg/m2; no antibiotic intake (last 30 days) * No intake of probiotics, prebiotics or synbiotics (last 15 days) * No intake vitamin C supplements (last 15 days) * No intake calcium supplements (last 15 days) Exclusion criteria: * Previous medical diagnosis of chronic kidney disease * Serum creatinine \>1.2 mg/dL * Glomerular filtration \<60 mL/min or 130 mL/min * Type 2 diabetes * Renal tubular acidosis * Pregnancy Elimination criteria: * Not meeting 80% adherence to treatment * Antibiotic consumption during the intervention
Where this trial is running
Mérida, Yucatán
- Azalia Avila Nava, PhD — Mérida, Yucatán, Mexico (Recruiting)
Study contacts
- Study coordinator: Azalia Avila-Nava, PhD
- Email: zomi33@gmail.com
- Phone: 01 999 94 27600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.