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

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.