| 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
|
|
|
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
|
|
|
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. |