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A Study Evaluating the Risk Factors for Kidney Stones and the Effect of Probiotic Use on Kidney Stones by Changing Gut Flora

Two-Phase Study Evaluating the Risk Factors for Kidney Stone Disease (KSD) and Effect of Probiotic Use on KSD by Change in Gut Microbiota

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/069726
Enrollment
216
Registered
2024-07-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N200- Calculus of kidney

Interventions

Intervention1: Multi-strain probiotic along with dietary counselling: Multi-strain probiotic capsule - Live freeze dried lactic acid bacteria and bifidobacteria in a concentration of112.5 Billion CFU,

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
1)Difference in 24 hour urinary parameters between the two arms and between baseline and at the end of 12 weeks post randomization. 2)Difference in the gut microbiota profile between the two arms and between baseline and end of 12 weeks.Timepoint: 12 weeks after randomization

Secondary

MeasureTime frame
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

Countries

India

Contacts

Public ContactDr Anitha Swamy

All India Institute of Medical Sciences, Bibinagar, HMR

dr.anitha.15@gmail.com9014016207

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026