- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05511337
Gut Microbiota in Patients With Urolithiasis
Effect of Control in Oxalate and Citrate Intake on Gut Microbiota Composition in Patients With Urolithiasis: Double-blind Randomized Clinical Study
Study Overview
Status
Conditions
Detailed Description
The protocol will be carried out in the Hospital Regional de Alta Especialidad de la Península de Yucatán (HRAEPY). This is double-blind randomized clinical study will be carried out in adults with a diagnosis of UL. Participants with UL are randomized by into three groups for 28 days. Control group: Caloric restriction, restriction of 500 kilocalories from the usual diet, or Intervention A: Restriction of 500 kilocalories from the usual diet plus a decrease in oxalate-rich foods (< 40 mg per day) and an increase in citrate-rich foods (> 40 mEq per day), or Intervention B: Real-life intervention with control oxalate and citrate foods: decrease in oxalate-rich foods (< 40 mg per day) and an increase in citrate-rich foods (> 40 mEq per day) without restriction of kilocalories from the usual diet. Randomization was performed by balanced blocks of three cells, with the research randomizer randomization program, 60 sites were randomized, which 20 participants were divided into three groups. Randomization was carried out by a person outside the study.
At the beginning and at the end of the interventions, the following characteristics will be determined anthropometric measurements (weight, height, waist circumference, body mass index (BMI)) and blood pressure. A 24-h urine sample is requested to determine oxalates and citrates. A fasting blood sample of 8-10 hours will be requested for the determination of the concentration of creatinine, uric acid, calcium, phosphorus and sodium. A stool sample will also be requested for DNA extraction, which will be used for analysis of the composition and biodiversity of the intestinal microbiota. The person performing of measurements will be blinded to the group to which each participant belongs. Treatment will be given only through dietary counseling. Follow-up is done by telephone monitoring once a week through logbook and reminders. At the end of the study, the statistical analysis will be performed by a person who is blinded to the group to which the participants belong.
The sample size was calculated with the formula for comparison of two proportions, with a one-tailed significance of 0.05 and a power of 80%, with a change in alpha diversity in the intervention group of 57% and in the control group of 18%. The result was 16 patients per group, but a 20% loss was considered. Therefore, a total of 20 participants per group was considered.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Azalia Avila-Nava, PhD
- Phone Number: 54440 01 999 94 27600
- Email: zomi33@gmail.com
Study Locations
-
-
Yucatán
-
Mérida, Yucatán, Mexico, 97130
- Recruiting
- Azalia Avila Nava, PhD
-
Contact:
- Azalia A Nava, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Control
Caloric restriction
|
Restriction of 500 kilocalories from the usual diet for 28 days.
The treatment will be given through an individualized meal plan
|
Experimental: Intervention A
Caloric restriction and control oxalate and citrate food
|
Restriction of 500 kilocalories from the usual diet plus a decrease in oxalate-rich foods (< 40 mg per day) and an increase in citrate-rich foods (> 40 mEq per day) for 28 days.
The treatment will be given through an individualized meal plan.
|
Experimental: Intervention B
Real-life intervention, control of oxalates and citrates without restriction of kilocalories.
|
Decrease in oxalate-rich foods (< 40 mg per day) and an increase in citrate-rich foods (> 40 mEq per day) without restriction in kilocalories from the usual diet for 28 days.
Treatment will be given only through dietary counseling.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative abundance of gut microbiota
Time Frame: At the beginning of the study and after 28 days of intervention
|
Changes in relative abundance of phylum, gender and species of bacteria in gut microbiota
|
At the beginning of the study and after 28 days of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentration of urinary citrate excretion
Time Frame: At the beginning of the study and after 28 days of intervention
|
Changes in concentration of citrate excretion in 24-hour urine
|
At the beginning of the study and after 28 days of intervention
|
Concentration of urinary oxalate excretion
Time Frame: At the beginning of the study and after 28 days of intervention
|
Changes in concentration of oxalate excretion in 24-hour urine
|
At the beginning of the study and after 28 days of intervention
|
Concentration of serum creatinine
Time Frame: At the beginning of the study and after 28 days of intervention
|
Changes in concentration of creatinine in serum
|
At the beginning of the study and after 28 days of intervention
|
Concentration of serum calcium
Time Frame: At the beginning of the study and after 28 days of intervention
|
Changes in concentration of calcium in serum
|
At the beginning of the study and after 28 days of intervention
|
Concentration of serum uric acid
Time Frame: At the beginning of the study and after 28 days of intervention
|
Changes in concentration of uric acid in serum
|
At the beginning of the study and after 28 days of intervention
|
Concentration of serum phosphorus
Time Frame: At the beginning of the study and after 28 days of intervention
|
Changes in concentration of phosphorus in serum
|
At the beginning of the study and after 28 days of intervention
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Del Chierico F, Vernocchi P, Dallapiccola B, Putignani L. Mediterranean diet and health: food effects on gut microbiota and disease control. Int J Mol Sci. 2014 Jul 1;15(7):11678-99. doi: 10.3390/ijms150711678.
- Zuckerman JM, Assimos DG. Hypocitraturia: pathophysiology and medical management. Rev Urol. 2009 Summer;11(3):134-44.
- Areses Trapote R, Urbieta Garagorri MA, Ubetagoyena Arrieta M, Mingo Monge T, Arruebarrena Lizarraga D. [Evaluation of renal stone disease: metabolic study]. An Pediatr (Barc). 2004 Nov;61(5):418-27. doi: 10.1016/s1695-4033(04)78417-9. Spanish.
- Medina-Escobedo M, Zaidi M, Real-de Leon E, Orozco-Rivadeneyra S. [Urolithiasis prevalence and risk factors in Yucatan, Mexico]. Salud Publica Mex. 2002 Nov-Dec;44(6):541-5. Spanish.
- Ticinesi A, Milani C, Guerra A, Allegri F, Lauretani F, Nouvenne A, Mancabelli L, Lugli GA, Turroni F, Duranti S, Mangifesta M, Viappiani A, Ferrario C, Dodi R, Dall'Asta M, Del Rio D, Ventura M, Meschi T. Understanding the gut-kidney axis in nephrolithiasis: an analysis of the gut microbiota composition and functionality of stone formers. Gut. 2018 Dec;67(12):2097-2106. doi: 10.1136/gutjnl-2017-315734. Epub 2018 Apr 28.
- Stanislawski MA, Frank DN, Borengasser SJ, Ostendorf DM, Ir D, Jambal P, Bing K, Wayland L, Siebert JC, Bessesen DH, MacLean PS, Melanson EL, Catenacci VA. The Gut Microbiota during a Behavioral Weight Loss Intervention. Nutrients. 2021 Sep 18;13(9):3248. doi: 10.3390/nu13093248.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Pathological Conditions, Anatomical
- Calculi
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Urinary Calculi
- Urolithiasis
- Molecular Mechanisms of Pharmacological Action
- Anticoagulants
- Chelating Agents
- Sequestering Agents
- Calcium Chelating Agents
- Citric Acid
- Sodium Citrate
Other Study ID Numbers
- 2020-022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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