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| ID | Type | Description | Link |
|---|---|---|---|
| H-41912 | Other Grant/Funding Number | Burroughs Wellcome |
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| Name | Class |
|---|---|
| Jawaharlal Institute of Postgraduate Medical Education & Research | OTHER_GOV |
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The objectives of this research are to determine:
In this study the researchers will investigate how intestinal parasites impact the nutritional status of TB patients before the start of nutritional supplementation and how they alter the trajectory of weight gain in those receiving supplementation by analyzing results from 2 cohorts.
LEOPARD Cohort 1-
LEOPARD Cohort 2 -
LEOPARD Cohort 1-
Control:
TB LION:
LEOPARD Cohort 2-
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEOPARD Cohort 1 | Control group: The study will enroll 50 newly diagnosed smear-positive (>/=1+ AFB) pulmonary TB patients whose household contacts are enrolled in the TB-LION study and who are not receiving nutritional supplementation. TB LION group: The study will enroll 50 newly diagnosed smear-positive (>/=1+ AFB) pulmonary TB patients whose household contacts are enrolled in the TB-LION study and who are receiving nutritional supplementation. | ||
| LEOPARD Cohort 2 | The study will enroll 300 newly diagnosed smear-positive (>/=1+ AFB) pulmonary TB patients whose household contacts are not enrolled in the TB-LION study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent of participants who successfully complete TB treatment | The number of participants that successfully completed treatment without bacteriological evidence of failure for two continuous weeks will be divided by the number of participants who started TB treatment. | 6 months |
| Body Mass Index (BMI) at the end of treatment | BMI will be calculated as weight/height in kg/m2. The height of participants will be measured by study team members at a home visit . Height will be measured to the nearest 0.5 cm with a stadiometer (or knee height, ulnar length or arm span [demispan] for those persons unable to stand fully erect). Body weight will be measured to the nearest 0.1 kg. Low BMIs <18.5 are associated with malnutrition. | 6 months |
| Detection of parasites in stool specimen | Stool specimens collected at the first visit will be tested for intestinal parasites using polymerase chain reaction (PCR). | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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The study population is newly diagnosed smear-positive (>/=1+ AFB) pulmonary TB patients living in Puducherry and Tamil Nadu.
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| Name | Affiliation | Role |
|---|---|---|
| Pranay Sinha, MD | Boston Medical Center | Principal Investigator |
| Pakrash Babu Narasimhan, PhD | Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States | ||
| Jawaharlal Institute of Postgraduate Medical Education and Research |
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| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| D006373 | Helminthiasis |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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Blood, sputum and stool samples will be collected and some samples will be retained for future testing. The PaxGene tubes will be collected and stored for future analysis to study RNA sequences for transcriptional differences between persons with TB with and without intestinal infections. Plasma samples and analysis of analytes will be analyzed to investigate further the immunologic mechanisms and to assess how these responses are modulated over time by treatment of parasites and by feeding individuals. Serum samples will be retained for future analysis of micronutrients and assessment of the immune response. Stool samples will be frozen for future microbiome analysis. Sputum samples obtained for the study will be assessed for differentially culturable TB variants.
| Puducherry |
| 605006 |
| India |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010272 | Parasitic Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |