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CTRI Number  CTRI/2026/02/104267 [Registered on: 19/02/2026] Trial Registered Prospectively
Last Modified On: 18/02/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Real-World Study 
Study Design  Single Arm Study 
Public Title of Study   A Real-World Study to Assess the Benefits and Safety of the Probiotic Lobun Forte in Patients with Chronic Kidney Disease in India. 
Scientific Title of Study   A Multicentric, Prospective, Observational Study to Evaluate the Real World Effectiveness and Safety of Probiotic Supplementation with Lobun Forte in Patients with Chronic Kidney Disease in India. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
JB-25-06 Version: 1.0 Dated 16 Dec 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kapil Mehta 
Designation  Head - Medical Affairs 
Affiliation  J. B. chemicals & pharmaceuticals LTD. 
Address  J. B. chemicals & pharmaceuticals LTD., Cnergy IT Park, Unit A2, 3rd floor & Unit A, 8th floor, Appa Saheb Marathe Marg, Prabhadevi, Mumbai.

Mumbai
MAHARASHTRA
400025
India 
Phone  7874856742  
Fax    
Email  kapil.mehta@jbpharma.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jayesh Sanmukhani 
Designation  Head - Medical Services 
Affiliation  Clinexcel Research 
Address  297, Second Floor, Sobo Center, South Bopal, Ahmedabad

Ahmadabad
GUJARAT
380058
India 
Phone  7600012192  
Fax    
Email  drjayesh@clinexcelresearch.com  
 
Details of Contact Person
Public Query  
Name  Dr Jayesh Sanmukhani 
Designation  Head - Medical Services 
Affiliation  Clinexcel Research 
Address  297, Second Floor, Sobo Center, South Bopal, Ahmedabad

Ahmadabad
GUJARAT
380058
India 
Phone  7600012192  
Fax    
Email  drjayesh@clinexcelresearch.com  
 
Source of Monetary or Material Support  
J. B. chemicals & pharmaceuticals LTD., Cnergy IT Park, Unit A2, 3rd floor & Unit A, 8th floor, Appa Saheb Marathe Marg, Prabhadevi, Mumbai 400025 
 
Primary Sponsor  
Name  J. B. chemicals & pharmaceuticals LTD. 
Address  J. B. chemicals & pharmaceuticals LTD., Cnergy IT Park, Unit A2, 3rd floor & Unit A, 8th floor, Appa Saheb Marathe Marg, Prabhadevi, Mumbai 400025 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rutul Dave  Anik Neuro-Nephro Clinic  Anik Neuro-Nephro Clinic, Shop no 204/5, Sun avenue one, Manekbaug Shyamal road, Tulip Rd, Ahmedabad, Gujarat 380015
Ahmadabad
GUJARAT 		 7567196811

rtldave@gmail.com 
Dr Medi Naveen Kumar  DRIEMS Institute of Health Sciences and Hospitals  DRIEMS Institute of Health Sciences and Hospitals, DRIEMS Road, Kotasahi, Tangi, Odisha 754025
Cuttack
ORISSA 		 9592918764

naveenkumar.medi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
ACEAS-Independent Ethics Committee  Approved 
Ethics committee Shanti Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), (2) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Adults aged 18 years and above with a confirmed diagnosis of CKD Stage III and IV.
2.Patients with stable CKD management for at least two weeks prior to enrolling in the study.
3.Patients prescribed Lobun Forte alongside standard treatment for at least 12 weeks.
4.Patients willing to attend a follow-up visit at the end of 6 weeks and after 12 weeks. 
 
ExclusionCriteria 
Details  1.Patients undergoing haemodialysis.
2.Patients with acute kidney injury or a recent renal transplant.
3.Patients requiring hospitalization during the study period.
4.Pregnant or lactating women.
5.Patients receiving any other probiotic therapy or who have used probiotics in the last 1
week.
6.Patients with a history of allergic reaction to probiotics or any component of Lobun Forte 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in Blood Urea Nitrogen (BUN) levels  At Baseline to week 12 (end of treatment) 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Serum Creatinine levels.  Day 0 (Baseline) to at week 12 (End of treatment). 
Change in Estimated Glomerular Filtration Rate (eGFR).  Day 0 (Baseline) to at week 12 (End of treatment). 
Change in Quality of Life (QoL) scores, as measured by a validated scale.  Day 0 (Baseline) to at week 12 (End of treatment). 
Change in severity & frequency of itching (pruritus) from baseline to end of
treatment, assessed using a standardized itching severity scale. 		 Day 0 (Baseline) to at week 12 (End of treatment). 
Change in incidence & severity of gastrointestinal (GI) discomfort (e.g., nausea,
bloating, abdominal pain) from baseline to end of treatment, assessed by patientreported
outcomes or symptom diary. 		 Day 0 (Baseline) to at week 12 (End of treatment). 
Mean change in total appetite score.  Day 0 (Baseline) to at week 12 (End of treatment). 
Proportion of patients showing 25% or more improvement in eGFR or 25% or more reduction in serum creatinine.  Day 0 (Baseline) to at week 12 (End of treatment). 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   03/03/2026 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   This is a Multicentric, Prospective, Observational Study to Evaluate the Real-World Effectiveness and Safety of Probiotic Supplementation with Lobun Forte in Patients with Chronic Kidney Disease in India. The primary objective of the study is to assess the effectiveness of Probiotic Supplementation with Lobun Forte, measured by the mean change in BUN from baseline to end of treatment. The secondary objective is to evaluate the safety of the investigational product. Approximately 200 patients are expected to be enrolled. Data collection will include demographic information, medical history, clinical symptoms, treatment details, and adverse events. 
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