Tuberculosis - Learning the Effect of Parasites and Reinforcing Diets

Study Overview
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Brief Summary
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The objectives of this research are to determine: the burden of intestinal parasitic infections among persons living with pulmonary tuberculosis (TB) whether intestinal parasitic infections alter TB treatment outcomes, including speed of sputum clearance and treatment outcomes the impact of malnutrition on speed of sputum clearance and TB treatment outcomes whether nutritional supplementation improves speed of sputum clearance and treatment outcomes 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- Control-Enroll TB cases, screen for undernutrition, obtain stool for intestinal parasite screening by polymerase chain reaction (PCR), and assess them for treatment outcomes and weight gain TB LION (Learning Impact of Nutrition) - Enroll TB cases, provide nutritional supplementation for 6 months (as part of existing TB LION study), screen for undernutrition, obtain stool for intestinal parasite screening by PCR, and assess them for treatment outcomes and weight gain LEOPARD Cohort 2 - Enroll TB cases, screen for undernutrition, obtain stool for internal parasite screening by PCR, and assess them for treatment outcomes and weight gain.

Detailed Description
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LEOPARD Cohort 1- Control: Pulmonary TB patients who are newly diagnosed smear-positive (>/=1+ Acid-fast bacillus/AFB) and whose household contacts are enrolled in the TB-LION (Learning Impact of Nutrition) study but are not receiving nutritional supplementation 50 participants will be enrolled and followed for up to 12 months Stool sample will be collected at the week 1 visit (visit 2) Blood samples will be collected the screening visit, week 1, month 2, and month 6 Sputum samples will be collected at the screening visit, week 1, week 2, and month 6 TB LION: Pulmonary TB patients who are newly diagnosed smear-positive (>/=1+ AFB) and whose household contacts are enrolled in the TB-LION study and are receiving nutritional supplementation 50 participants will be enrolled and followed for up to 12 months Index case and rest of household will receive nutritional supplementation for 6 months Stool sample will be collected at the week 1 visit (visit 2) Blood samples will be collected at the screening visit, week 1, month 2, and month 6 Sputum samples will be collected at the screening visit, week 1, week 2, and month 6 LEOPARD Cohort 2- Pulmonary TB patients who are newly diagnosed smear-positive (>/=1+ AFB) and whose household contacts are not enrolled in the TB-LION study 300 participants will be enrolled and followed for up to 6 months Stool sample will be collected at the week 1 visit (visit 2) Blood samples will be collected at the screening visit and week 1 Sputum samples will be collected at the screening visit, week 1, and week 2

Official Title
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Tuberculosis - Learning the Effect of Parasites and Reinforcing Diets (TB-LEOPARD)

Conditions
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Tuberculosis, Pulmonary, Helminthiasis, Malnutrition

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sputum Ziehl-Neelsen stain positive for AFB (≥1+) Culture or Xpert positive for Mtb; those who are smear+ but ultimately Xpert or culture negative, will be included until their culture results return at which time they will retrospectively be removed from the study. No history of TB treatment (i.e., no history of partial or complete treatment for a previous TB episode) Has at least 1 household contact with whom they have shared a house with during the previous one month Agrees to have household contact notified about study Exclusion Criteria: Household contact ineligible for TB LION study Pregnant at enrollment Previously diagnosed with diabetes or hemoglobin A1c>6.5% on testing No Xpert or culture confirmation and unable to provide sputum sample Known multidrug-resistant tuberculosis (MDR) or extensively drug resistant (XDR) TB case at recruitment or found at time of enrollment BMI <14 kg/m2 Lower extremity edema/kwashiorkor Reported neuropathy in lower extremities (may result from thiamine deficiency)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LEOPARD Cohort 1<br>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<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutritional supplements, TB LION, India