Gut Microbiota in Patients With Urolithiasis

NCT05511337 | Unknown DMC

• 1 other identifier: 2020-022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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%. 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.

Conditions

Urolithiasis

Outcome Measures

Primary Outcomes (1)

• Relative abundance of gut microbiota

  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 Outcomes (6)

• Concentration of urinary citrate excretion

  At the beginning of the study and after 28 days of intervention

• Concentration of urinary oxalate excretion

  At the beginning of the study and after 28 days of intervention

• Concentration of serum creatinine

  At the beginning of the study and after 28 days of intervention

• Concentration of serum calcium

  At the beginning of the study and after 28 days of intervention

• Concentration of serum uric acid

  At the beginning of the study and after 28 days of intervention

Study Arms (3)

Control

OTHER

Caloric restriction

Other: Caloric restriction

Intervention A

EXPERIMENTAL

Caloric restriction and control oxalate and citrate food

Other: Caloric restriction and control oxalate and citrate foods

Intervention B

EXPERIMENTAL

Real-life intervention, control of oxalates and citrates without restriction of kilocalories.

Other: Real-life intervention with control oxalate and citrate foods

Interventions

Caloric restriction and control oxalate and citrate foods OTHER

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.

Intervention A

Caloric restriction OTHER

Restriction of 500 kilocalories from the usual diet for 28 days. The treatment will be given through an individualized meal plan

Control

Real-life intervention with control oxalate and citrate foods OTHER

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.

Intervention B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Regional de Alta Especialidad de la Península de Yucatán: lead

Study Sites (1)

Azalia Avila Nava, PhD

Mérida, Yucatán, 97130, Mexico

RECRUITING

Related Publications (6)

• 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.

  PMID: 15530322 BACKGROUND

• 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.

  PMID: 20383456 BACKGROUND

• Zuckerman JM, Assimos DG. Hypocitraturia: pathophysiology and medical management. Rev Urol. 2009 Summer;11(3):134-44.

  PMID: 19918339 BACKGROUND

• 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.

  PMID: 29705728 BACKGROUND

• 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.

  PMID: 24987952 BACKGROUND

• 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.

  PMID: 34579125 BACKGROUND

Related Links

• Manejo nutriológico en el paciente con litiasis renal

MeSH Terms

Conditions

Urolithiasis

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Azalia Avila-Nava, PhD

CONTACT

01 999 94 27600; zomi33@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The person performing the measurements will be blinded to the group to which each participant belongs. The statistical analysis will be performed by a person who is blinded to the group to which the participants belong.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 23, 2022
• Study Start: December 15, 2022
• Primary Completion: December 1, 2024
• Study Completion: August 1, 2025
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)