UrolithiasisNCT05511337
Gut Microbiota in Patients With Urolithiasis
A study testing Caloric restriction in people with Urolithiasis, run by Hospital Regional de Alta Especialidad de la Península de Yucatán at 1 site in Mexico.
Trial summary
Urolithiasis (UL) is the presence of kidney stones in different compartments such as ureters, bladder and/or urethra. Based on its incidence and prevalence it is considered a public health problem worldwide. In Mexico, especially in Yucatan state, is considered an endemic area of UL with a prevalence of 5.5%. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Caloric restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 15 Dec 2022to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Elimination criteria:
- Not meeting 80% adherence to treatment
- Antibiotic consumption during the intervention
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Azalia Avila Nava, PhD
Mérida, Yucatán, 97130
Azalia A Nava, PhD
About this study
Official title: Effect of Control in Oxalate and Citrate Intake on Gut Microbiota Composition in Patients With Urolithiasis: Double-blind Randomized Clinical Study
Urolithiasis (UL) is the presence of kidney stones in different compartments such as ureters, bladder and/or urethra. Based on its incidence and prevalence it is considered a public health problem worldwide. In Mexico, especially in Yucatan state, is considered an endemic area of UL with a prevalence of 5.5%. There are several risk factors associated with the development of UL, among which are genetics, age, sex, excess weight, diet, and gut microbiota. In the diet there is promoters and inhibitors of stone formation, such as oxalates and citrates respectively. The gut microbiota is the set of microorganisms that inhabit the gastrointestinal tract, which have been related to the regulation of metabolic processes such as production of short-chain fatty acids (SCFA), vitamin K synthesis, and stimulation of the immune response. However, alterations in the composition of the microbiota have been associated with the development of various pathologies including UL. Recent studies have shown that the intestinal microbiota of people with kidney stones have a lower diversity and a different bacterial composition compared with healthy people, suggesting that interactions in the gut-renal axis could have a direct effect on the development of UL. Furthermore, these modifications could modulate oxalate and citrate transporters. Dietary modifications may decrease the risk of UL formation through increased consumption of citrate-rich foods (>40 mEq per day) and decreased consumption of oxalate-rich foods (< 40mg per day). It is known that dietary modifications can modulate the gut microbiota, however there is no evidence about the effect of a dietary intervention with oxalate and citrate control on the modulation of the microbiota in patients with UL. Thus, it is important to search for strategies to reduce UL, as well as the complications associated with them like chronic kidney disease. The main of the study is evaluate the effect of a dietary intervention with oxalate and citrate control on the composition and diversity of the intestinal microbiota of adults with UL.
Read the 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.
- Conditions
- Urolithiasis
- Being tested
- Caloric restriction and control oxalate and citrate foods, Caloric restriction, Real-life intervention with control oxalate and citrate foods
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric restriction and control oxalate and citrate foodsOther
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.
Caloric restrictionOther
Restriction of 500 kilocalories from the usual diet for 28 days. The treatment will be given through an individualized meal plan
Real-life intervention with control oxalate and citrate foodsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Caloric restriction Receives: Other: Caloric restriction |
| Intervention A | Experimental | Caloric restriction and control oxalate and citrate food Receives: Other: Caloric restriction and control oxalate and citrate foods |
| Intervention B | Experimental | Real-life intervention, control of oxalates and citrates without restriction of kilocalories. Receives: Other: Real-life intervention with control oxalate and citrate foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative abundance of gut microbiota
Changes in relative abundance of phylum, gender and species of bacteria in gut microbiota
Measured: At the beginning of the study and after 28 days of intervention
Secondary outcomes (6)
Concentration of urinary citrate excretion
Changes in concentration of citrate excretion in 24-hour urine
Measured: At the beginning of the study and after 28 days of intervention
Concentration of urinary oxalate excretion
Changes in concentration of oxalate excretion in 24-hour urine
Measured: At the beginning of the study and after 28 days of intervention
Concentration of serum creatinine
Changes in concentration of creatinine in serum
Measured: At the beginning of the study and after 28 days of intervention
Concentration of serum calcium
Changes in concentration of calcium in serum
Measured: At the beginning of the study and after 28 days of intervention
Concentration of serum uric acid
Changes in concentration of uric acid in serum
Measured: At the beginning of the study and after 28 days of intervention
Concentration of serum phosphorus
Changes in concentration of phosphorus in serum
Measured: At the beginning of the study and after 28 days of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start15 Dec 2022
- Primary completionDec 2024 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized into three groups for 28 days: Control: caloric restriction or intervention A: Control oxalate and citrate foods or intervention B: Real-life intervention, control of oxalates and citrates without restriction of kilocalories. 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. Treatment will be given only through dietary counseling. Treatment adherence will be assessed in all groups through three food diaries (two on weekdays and one on weekends). Adherence will be considered if the participant complies with 80% of the treatment.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Regional de Alta Especialidad de la Península de Yucatán
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azalia Avila Nava, PhD, Hospital Regional de Alta Especialidad de la Península de Yucatán
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511337
- Sponsor's protocol ID
- 2020-022
- Status last verified
- Dec 2023
- First submitted
- 19 Aug 2022
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15530322Medina-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.
PubMed 20383456Zuckerman JM, Assimos DG. Hypocitraturia: pathophysiology and medical management. Rev Urol. 2009 Summer;11(3):134-44.
PubMed 19918339Ticinesi 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.
PubMed 29705728Del 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.
PubMed 24987952Stanislawski 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.
PubMed 34579125
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Control in Oxalate and Citrate Intake on Gut Microbiota Composition in Patients With Urolithiasis: Double-blind Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT05511337
- Acronym / sponsor ID
- 2020-022
- Conditions
- Urolithiasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Regional de Alta Especialidad de la Península de YucatánUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Urolithiasis (UL) is the presence of kidney stones in different compartments such as ureters, bladder and/or urethra. Based on its incidence and prevalence it is considered a public health problem worldwide. In Mexico, especially in Yucatan state, is considered an endemic area of UL with a prevalence of 5.5%. There are several risk factors associated with the development of UL, among which are genetics, age, sex, excess weight, diet, and gut microbiota. In the diet there is promoters and inhibitors of stone formation, such as oxalates and citrates respectively. The gut microbiota is the set of microorganisms that inhabit the gastrointestinal tract, which have been related to the regulation of metabolic processes such as production of short-chain fatty acids (SCFA), vitamin K synthesis, and stimulation of the immune response. However, alterations in the composition of the microbiota have been associated with the development of various pathologies including UL. Recent studies have shown that the intestinal microbiota of people with kidney stones have a lower diversity and a different bacterial composition compared with healthy people, suggesting that interactions in the gut-renal axis could have a direct effect on the development of UL. Furthermore, these modifications could modulate oxalate and citrate transporters. Dietary modifications may decrease the risk of UL formation through increased consumption of citrate-rich foods (>40 mEq per day) and decreased consumption of oxalate-rich foods (< 40mg per day). It is known that dietary modifications can modulate the gut microbiota, however there is no evidence about the effect of a dietary intervention with oxalate and citrate control on the modulation of the microbiota in patients with UL. Thus, it is important to search for strategies to reduce UL, as well as the complications associated with them like chronic kidney disease. The main of the study is evaluate the effect of a dietary intervention with oxalate and citrate control on the composition and diversity of the intestinal microbiota of adults with UL.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants are randomized into three groups for 28 days: Control: caloric restriction or intervention A: Control oxalate and citrate foods or intervention B: Real-life intervention, control of oxalates and citrates without restriction of kilocalories. 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. Treatment will be given only through dietary counseling. Treatment adherence will be assessed in all groups through three food diaries (two on weekdays and one on weekends). Adherence will be considered if the participant complies with 80% of the treatment.
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Caloric restrictionCaloric restriction |
| Intervention A | Experimental | Other: Caloric restriction and control oxalate and citrate foodsCaloric restriction and control oxalate and citrate food |
| Intervention B | Experimental | Other: Real-life intervention with control oxalate and citrate foodsReal-life intervention, control of oxalates and citrates without restriction of kilocalories. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caloric restriction and control oxalate and citrate foodsRestriction 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. | Other | Intervention A |
| Caloric restrictionRestriction of 500 kilocalories from the usual diet for 28 days. The treatment will be given through an individualized meal plan | Other | Control |
| Real-life intervention with control oxalate and citrate foodsDecrease 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. | Other | Intervention B |
Primary outcome
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
6 secondary outcomes
Concentration of urinary citrate excretion
Time frame: 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
Concentration of serum creatinine
Time frame: 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
Concentration of serum uric acid
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Background: PubMed 15530322Areses 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.
- Background: PubMed 20383456Medina-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.
- Background: PubMed 19918339Zuckerman JM, Assimos DG. Hypocitraturia: pathophysiology and medical management. Rev Urol. 2009 Summer;11(3):134-44.
- Background: PubMed 29705728Ticinesi 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.
- Background: PubMed 24987952Del 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.
- Background: PubMed 34579125Stanislawski 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caloric restriction in people with Urolithiasis, run by Hospital Regional de Alta Especialidad de la Península de Yucatán at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Azalia Avila-Nava, PhD (01 999 94 27600 ext. 54440, zomi33@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative abundance of gut microbiota (time frame: At the beginning of the study and after 28 days of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05511337, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.