| 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
|
|
|
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
|
|
|
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. |