NCT06084715

The INSTITUT Study Tuberculosis Nutritional Support

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 769 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Tuberculosis, Pulmonary
• Undernutrition

Interventions

Type	Name	Description
OTHER	Nutritional support	The hospitals in Benin already provide nutritional support for patients with pulmonary TB which will continue throughout the study.

Timeline

• Start date: 2023-09-07
• Primary completion: 2025-09-10
• Completion: 2025-09-21
• First posted: 2023-10-16
• Last updated: 2025-11-17

Locations

2 sites across 2 countries: Benin, Togo