Status:
COMPLETED
The INSTITUT Study Tuberculosis Nutritional Support
Lead Sponsor:
Boston Medical Center
Collaborating Sponsors:
The International Union Against Tuberculosis and Lung Disease
Conditions:
Tuberculosis, Pulmonary
Undernutrition
Eligibility:
All Genders
18+ years
Brief 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...
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 sta...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 7 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 21 2025
Estimated Enrollment :
769 Patients enrolled
Trial Details
Trial ID
NCT06084715
Start Date
September 7 2023
End Date
September 21 2025
Last Update
November 17 2025
Active Locations (2)
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1
Centre Hospitalier et Universitaire de Pneumo-phtisiologie
Porto-Novo, Benin
2
National Tuberculosis Programme
Lomé, Togo