A Study Evaluating the Risk Factors for Kidney Stones and the Effect of Probiotic Use on Kidney Stones by Changing Gut Flora
- Conditions
- Health Condition 1: N200- Calculus of kidney
- Registration Number
- CTRI/2024/07/069726
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1)Newly diagnosed or recurrent kidney stone disease (KSD) patients diagnosed using ultrasonography (USG) abdomen of age 18 years or more at first presentation to our institute
2)Both symptomatic as well as asymptomatic cases will be included
1)Any antibiotic usage in the prior 3 months
2)Any history of diarrhoea one month prior to randomization
3)Chronic diarrhoea, malabsorption or history of any bowel resection
4)Any laxative or probiotic usage in prior 1 month
5)Patients with known risk factors for KSD such as primary hyperparathyroidism, distal RTA, gouty arthritis, polycystic kidney disease etc.
6)Cases of acute or chronic infections, malignancies, immunosuppression
7)Chronic kidney disease (CKD) with eGFR less than 30ml/min/1.72m2 (CKD-EPI formula)
8)Symptomatic stones requiring Urological intervention
9)Not consenting for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Difference in 24 hour urinary parameters between the two arms and between <br/ ><br>baseline and at the end of 12 weeks post randomization. <br/ ><br>2)Difference in the gut microbiota profile between the two arms and between baseline <br/ ><br>and end of 12 weeks.Timepoint: 12 weeks after randomization
- Secondary Outcome Measures
Name Time Method 1)Difference in USG profile between the two arms and between baseline and at the end of 12 weeks post randomization.Timepoint: 12 weeks after randomization