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Effect of probiotic supplement in tuberculosis patients

To compare and determine the effect of probiotic (lactic acid bacilli) supplementation on inflammatory biomarkers during intensive treatment phase of Pulmonary tuberculosis : A Prospective study - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/059867
Enrollment
78
Registered
2023-11-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A150- Tuberculosis of lung

Interventions

Intervention1: Probiotic - Bacillus coagulans and First Line Anti TB Drugs: Bacillus coagulans 120 Million CFU 1 Tablet Twice daily for 2 months. Isoniazid Rifampicin Pyrazinamide Ethambutol Control I

Sponsors

Sri Siddhartha Medical college
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed Pulmonary TB patients, aged 18-65 years ( as per WHO diagnostic criteria) Written consent from the patient

Exclusion criteria

Exclusion criteria: Patients of Extrapulmonary TB Pregnant women Immunocompromised patients and patients on immunosuppresive agents Patients with comorbidities like cardiovascular diseases (Hypertension, Ischaemic heart diseases, Cardiomyopathies), Diabetes, gastrointestinal disease, liver malfunction, tumor, severe mental or psychological illness, or cognitive impairment The use of probiotic supplementation within the previous 2 months. No informed consent

Design outcomes

Primary

MeasureTime frame
To analyse impact of probiotic supplementation on inflammatory biomarkers like CRP (C-reactive protein), ESR ( erythrocyte sedimentation rate), TLC( Total leucocyte count), NEU( neutrophil counts) , MPV( mean platelet volume) in intensive treatment phase of Tuberculosis.Timepoint: 2 time points Baseline and end of 2 months

Secondary

MeasureTime frame
To assess role of probiotics in the duration of sputum culture conversion To assess effect of probiotics on gastric side-effects of anti-tuberculosis treatment To assess role of probiotics in overall clinical improvement for TB patients taking treatment.Timepoint: 2 time points Baseline and end of 2 months

Countries

India

Contacts

Public ContactDr Sheeba Malik

Sri Siddhartha Medical College

sarojab676@gmail.com9900457045

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026