The INSTITUT Study

Study Overview
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Brief Summary
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Undernutrition is a leading global risk factor of tuberculosis (TB) and a prevalent comorbidity associated with TB. In Benin, the National TB Program systematically provides nutritional support to all persons with TB (PWTB), distributing prepared foods to hospitalized patients and food baskets during outpatient care. In Togo, the PWTB population is similar to that of Benin; however, Togo does not have a systematic program in place to provide nutritional support to these patients. The investigators will perform a prospective cohort analysis using anonymized TB patient data from the National TB Programs of Benin and Togo. Participants enrolled in Benin will receive nutritional support from the hospital while those enrolled in Togo will not. Participants in Togo who do not receive nutritional support will serve as a control. Unfavorable outcomes in both groups such as treatment failure, death, or relapse will be compared. The results from this study should help to shape TB programs in the future by incorporating nutritional support.

Detailed Description
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The objectives of this prospective cohort analysis are: To estimate the impact of nutritional support on TB treatment outcomes To estimate the impact of nutritional support on the nutritional status of persons with TB (PWTB) at the end of treatment. Pulmonary TB patients who meet eligibility criteria including being diagnosed with a smear-positive (>/=1+ AFB) and provide informed consent will be enrolled. A projected sample of 1050 participants will be enrolled and followed for approximately 12 months. 700 will be enrolled in Benin and 350 in Togo. Participants enrolled in Benin will receive nutritional support from the hospital while those enrolled in Togo will not. Sputum samples will be collected at baseline and month two to confirm diagnosis and resolution of disease. Chest X-rays will be taken at enrollment, if not available by the TB program, and repeated 6 months following the end of TB treatment to assess for post-TB chronic lung disease. At all visits, surveys will be administered to assess for response to treatment and functional and economic recovery.

Official Title
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Impact of Nutritional Support for Tuberculosis on Intermediate and Terminal Undernutrition and Treatment Outcomes: the INSTITUT Study

Conditions
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Tuberculosis, Pulmonary, Undernutrition

Intervention / Treatment
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* Other: Nutritional support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Drug susceptible, Xpert [polymerase chain reaction (PCR) test for TB] positive and/or sputum stain positive for AFB (≥1+) Willing to attend follow-up visits and undergo study procedures Exclusion Criteria: Drug resistant TB Has received 7 or more days of antimicrobial therapy Based on study staff observation, the participant is too sick to enroll. Defined as a score of 4 on the World Health Organization (WHO) Performance assessment. Pregnancy at the time of enrollment Individuals who are unable to participate in the 6-minute walk test due to pre-existing mobility issues due to disability, trauma, neurological compromise, or cardiopulmonary issues

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 |
| --- | --- |
| Nutritional support group<br>Participants in this group will be enrolled in Benin and will receive nutritional support from the hospital where they receive care. They will be followed for 12 months. | Other: Nutritional support<br>* The hospitals in Benin already provide nutritional support for patients with pulmonary TB which will continue throughout the study.<br>|
| Standard of care group<br>Participants in this group will be enrolled in Togo and will not receive nutritional support from the hospital where they receive care. They will be followed for 12 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of participants with an unfavorable outcome | An unfavorable outcome will be a composite of TB treatment failure, death, or relapse based on patient evaluation 6 months after treatment completion. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with failure of sputum conversion | Failure for those with positive sputum smears at treatment onset to convert to having negative sputum smears after 2 months of intensive therapy. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Persons with TB (PWTB), Nutritional support, Republic of Benin, Togolese Republic, Treatment failure, TB relapse, Chronic obstructive pulmonary disease (COPD), Quality of life