Health Condition 1: A159- Respiratory tuberculosis unspecified
Conditions
Interventions
Intervention1: Probiotic consortia product: This product will be given once daily for 12 weeks by mixing with water. Dose: 20mg/Kg for daily. Route of administration - orally
Intervention2: Prebiotic
Sponsors
Indian Council of Medical Research ICMR
Eligibility
Inclusion criteria
Inclusion criteria: Newly diagnosed, treatment-naive tuberculosis patients. Body Mass Index (BMI) less than 18.5 kg/m (undernourished). Able and willing to provide informed consent.
Exclusion criteria
Exclusion criteria: Presence of any significant gastrointestinal diseases or conditions such as IBD and IBS. Contraindications to probiotics, prebiotics, or IPA supplementation. Refusal to consent or inability to provide informed consent. Any medical comorbidities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identification of microbiome networks and metabolic markers predictive of treatment outcomes in cachectic TB patients. Evidence supporting the efficacy of probiotics/prebiotics and IPA in accelerating recovery in TB patients. Generate a paradigm shift in TB management using microbiome-targeted strategies to improve recovery and reduce undernutrition. Timepoint: Outcome will be assessed for Microbiome profile at 15, 30, 60, 90, 180 days. For metabolomics and inflammatory at 3, 6 months. body composition will be assessed at 3, 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| The outcomes in nutritional status (BMI) & the response to the diet & antitubercular treatment shall be documented at baseline & after six months (primary outcome). To document clinical parameters, BMI status, gut microbiota, & markers of inflammation.Timepoint: follow-up data shall be collected periodically after Day 15, Day 30, Day 60, & Day 90. | — |
Countries
India
Contacts
Public ContactDr Balamurugan Ramadass
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR
Outcome results
None listed