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CTRI Number  CTRI/2026/03/106146 [Registered on: 13/03/2026] Trial Registered Prospectively
Last Modified On: 12/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Probiotic Supplements in Reducing Inflammation in Patients Receiving Treatment for Tuberculosis 
Scientific Title of Study   Exploring the Gut-Lung Axis: Immunomodulatory Effects of Probiotic Supplementation on IL-6 levels in Tuberculosis Patients in Anti-Tuberculosis Treatment (ATT)-A Randomized, Open-Label, Clinical Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sandeep Kalaiselvan 
Designation  Postgraduate 
Affiliation  Sri Ramachandra Medical College and Research Institute 
Address  Wing E Office, Department of Pharmacology, 3rd floor, Medical College Building, No.1, Ramachandra Nagar, Porur, Chennai

Kancheepuram
TAMIL NADU
600116
India 
Phone  9698262091  
Fax    
Email  sandeep.kmarch1996@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Anusha D 
Designation  Professor 
Affiliation  Sri Ramachandra Medical College and Research Institute 
Address  Wing E Office, Department of Pharmacology, 3rd floor, Medical College Building, No.1, Ramachandra Nagar, Porur, Chennai

Kancheepuram
TAMIL NADU
600116
India 
Phone  9884313112  
Fax    
Email  drdanusha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sandeep Kalaiselvan 
Designation  Postgraduate 
Affiliation  Sri Ramachandra Medical College and Research Institute 
Address  Wing E Office, Department of Pharmacology, 3rd floor, Medical College Building, No.1, Ramachandra Nagar, Porur, Chennai

Kancheepuram
TAMIL NADU
600116
India 
Phone  9698262091  
Fax    
Email  sandeep.kmarch1996@gmail.com  
 
Source of Monetary or Material Support  
ICMR PG-Thesis program 2025, Department of Health Research, HRD Scheme, 1st Floor, IRCS Building, 1, Red Cross Road, New Delhi - 110001. 
 
Primary Sponsor  
Name  Dr Sandeep Kalaiselvan 
Address  Wing E Office, Department of Pharmacology, 3rd floor, Medical College Building, No.1, Ramachandra Nagar, Porur, Chennai 600116 
Type of Sponsor  Other [Self] 
 
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 Anusha D  Sri Ramachandra Medical College and Research Institute  Department of Pulmonary Medicine, No. 1, Ramachandra Nagar, Porur, Chennai 600116
Kancheepuram
TAMIL NADU 
9884313112

drdanusha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL RESEARCH ETHICS COMMITTEE, SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH (DU)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A150||Tuberculosis of lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Capsule Probiotic, oral, once daily + Standard Anti-Tubercular Therapy  Capsule Probiotic, oral, once daily, each capsule containing Lactobacillus Acidophilus 1.33 billion CFUs, Lactobacillus Rhamnosus 0.72 billion CFUs, Bifidobacterium Longum 0.20 billion CFUs and Saccharomyces Boulardii 0.50 billion CFUs + Tablet Isoniazid 5mg/kg, Tablet Rifampicin 10mg/kg, Tablet Pyrazinamide 25mg/kg, Tablet Ethambutol 15mg/kg for 2 months 
Comparator Agent  Standard Anti-Tubercular Therapy  Tablet Isoniazid 5 mg/kg, Tablet Rifampicin 10 mg/kg, Tablet Pyrazinamide 25 mg/kg, Tablet Ethambutol 15 mg/kg for 2 months 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Newly diagnosed adult pulmonary TB patients with MTB geneXpert positivity
2. New TB patients with comorbidities T2DM, SHT, if under control 
 
ExclusionCriteria 
Details  1. Old patients of TB already under treatment
2. TB patients less than 20 years and more than 65 years of age
3. Pregnant and lactating women
4. TB patients with comorbidities like cancer, HIV and other immunosuppressants 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in IL6 levels in the patients receiving probiotics as add-on treatment along with standard ATT  At Baseline and at the end of 2 months 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in the occurrence of gastrointestinal adverse effects like vomiting and diarrhea in the patients receiving probiotics as add-on treatment along with standard ATT  At the end of two months 
 
Target Sample Size   Total Sample Size="222"
Sample Size from India="222" 
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   Phase 4 
Date of First Enrollment (India)   01/04/2026 
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="1"
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  

Tuberculosis can trigger an exaggerated immune response known as a cytokine storm, characterized by elevated inflammatory cytokines such as TNF alpha, IL-6, and IL-10, which are associated with pulmonary inflammation and lung damage. Among these, IL-6 has been shown to correlate with disease severity, and reducing its levels may help attenuate TB-related inflammation and improve treatment outcomes. The gut and lungs are interconnected through the gut–lung axis, where intestinal microbiota can influence immune responses in the lungs and regulate inflammatory processes during Mycobacterium tuberculosis infection. At the same time, long-term anti-tubercular therapy (ATT) is often associated with adverse effects such as gastrointestinal disturbances, hepatotoxicity, peripheral neuropathy, visual disturbances, and ototoxicity, which may lead to treatment interruption, drug resistance, and poor outcomes. Evidence suggests that probiotics can help reduce gastrointestinal adverse reactions related to ATT and may also have immunomodulatory effects. Considering these potential benefits, this study aims to assess the immunomodulatory effect of probiotics on IL-6 levels in tuberculosis patients and evaluate their role in reducing ATT-related gastrointestinal adverse events. Approval from the Institutional Ethics Committee has been obtained. Patient enrolment is yet to begin. After getting informed consent, a total of 222 newly diagnosed pulmonary TB patients will be randomly allocated into two groups of 111 each, where Group 1 will receive probiotics along with standard ATT and Group 2 will receive ATT alone. Patients will be followed for six months, and IL-6 levels will be measured at baseline and at the end of two months. Chest X-rays will be obtained at baseline and at the end of two months to assess radiological improvement. Patients will complete a sickness assessment scale to evaluate perceived treatment outcomes. From baseline till the end of 2 months, patients will also be monitored for gastrointestinal adverse effects to determine whether probiotic supplementation reduces ATT-related complications. The findings of this study may help determine whether probiotic supplementation can enhance the effectiveness of anti-tubercular therapy, improve patient recovery, and reduce treatment-related adverse effects, while also contributing to a better understanding of the gut–lung axis and the potential role of probiotics as an adjunct therapy for TB, particularly in high burden and resource limited settings.

 
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