Gut Microbiota in Patients With Urolithiasis

NCT05511337 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-12-26

No results posted yet for this study

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

Interventions

OTHER

Caloric restriction and control oxalate and citrate foods

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.

OTHER

Caloric restriction

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

OTHER

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 in kilocalories from the usual diet for 28 days. Treatment will be given only through dietary counseling.

Sponsors & Collaborators

  • Hospital Regional de Alta Especialidad de la Península de Yucatán

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2024-12-31
Completion
2025-08-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05511337 on ClinicalTrials.gov