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CTRI Number  CTRI/2024/07/069726 [Registered on: 01/07/2024] Trial Registered Prospectively
Last Modified On: 19/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study Evaluating the Risk Factors for Kidney Stones and the Effect of Probiotic Use on Kidney Stones by Changing Gut Flora 
Scientific Title of Study   Two-Phase Study Evaluating the Risk Factors for Kidney Stone Disease (KSD) and Effect of Probiotic Use on KSD by Change in Gut Microbiota  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anitha Swamy 
Designation  Assistant Professor Department of Nephrology 
Affiliation  All India Institute of Medical Sciences, Bibinagar, HMR 
Address  Room No. 1B17, Nephrology OPD, 1st Floor (Opposite MS office), B- Block, All India Institute of Medical Sciences, Bibinagar, Hyderabad Metropolitan Region

Nalgonda
TELANGANA
508126
India 
Phone  9014016207  
Fax    
Email  dr.anitha.15@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anitha Swamy 
Designation  Assistant Professor Department of Nephrology 
Affiliation  All India Institute of Medical Sciences, Bibinagar, HMR 
Address  Room No. 1B17, Nephrolohy OPD, 1st Floor (Opposite MS Office), B Block, All India Institute of Medical Sciences, Bibinagar, Hyderabad Metropolitan Region

Nalgonda
TELANGANA
508126
India 
Phone  9014016207  
Fax    
Email  dr.anitha.15@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anitha Swamy 
Designation  Assistant Professor Department of Nephrology 
Affiliation  All India Institute of Medical Sciences, Bibinagar, HMR 
Address  Room No. 1B17, Nephrology OPD, 1st Floor (Opposite MS Office), B Block, All India Institute of Medical Sciences, Bibinagar, Hyderabad Metropolitan Region

Nalgonda
TELANGANA
508126
India 
Phone  9014016207  
Fax    
Email  dr.anitha.15@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V. Ramalingaswami Bhawan, P.O. Box No.4911, Ansari Nagar, New Delhi-110029 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anitha Swamy  All India Institute of Medical Sciences, Bibinagar, Hyderabad Metropolitan Region  Room No. 1B17, Nephrology OPD, 1st Floor, B Block
Nalgonda
TELANGANA 
9014016207

dr.anitha.15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Bibinagar, Hyderabad Metropolitan Region, Institutional Ethics Committee (AIIMS BBN-IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N200||Calculus of kidney,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dietary counselling  Routine standard of care will be given in the form of a dietary counselling. 
Intervention  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, one capsule per day for a total of eight weeks along with routine standard of care in the form of dietary counselling. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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  
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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. 
12 weeks after randomization 
 
Secondary Outcome  
Outcome  TimePoints 
1)Difference in USG profile between the two arms and between baseline and at the end of 12 weeks post randomization.  12 weeks after randomization 
 
Target Sample Size   Total Sample Size="216"
Sample Size from India="216" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Kidney Stone Disease (KSD) imposes a significant societal cost due to its high prevalence and recurrence rates, impacting both patient health and the economy. The most affected age group, 21-40 years, is at its peak productivity. In our institute in Bibinagar, Telangana, we’ve observed a high influx of KSD patients, prompting a study to identify specific risk factors in this area. We wish to conduct this hospital-based study in two phases. The first phase will be a cross-sectional comparative study to identify the risk factors for KSD, including demographic, lifestyle, metabolic, dietary, and environmental factors among the OPD patients presenting to our institute, which is a tertiary care hospital. The gut microbiota will be evaluated in a subset of patients with KSD in comparison to matched controls. The second phase of the study will be an open label RCT with probiotic supplementation in the treatment arm, in addition to the routine standard of care in patients with KSD. A multi-strain probiotic in a dose of 112.5 billion CFU will be given one capsule per day for a total of 8 weeks to the intervention arm along with routine standard of care in the form of dietary counselling. The 24-hour urine parameters and gut microbiota will be rechecked at the end of 12 months along with a repeat USG to see the differences between the two arms and from baseline. In India, no studies have examined probiotic use in KSD. We propose a randomized controlled trial (RCT) to assess the beneficial effect of multi-strain probiotics on KSD patients, potentially offering insights for more effective preventive and therapeutic measures.

 
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