Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The INSTITUT Study is looking at how nutritional support can impact the treatment outcomes for people with tuberculosis (TB) in two West African countries: Benin and Togo. In Benin, patients with TB receive special food support from the hospital, while in Togo, they do not have this assistance. This study will compare the health outcomes of TB patients in both countries to see if the nutritional support makes a difference in their recovery, including rates of treatment failure, relapse, or even death.
To be eligible for this study, participants must be diagnosed with drug-susceptible TB and be willing to attend follow-up visits. However, those with drug-resistant TB or who are too ill to participate, among other criteria, will not be included. If you join the study, you'll be asked to keep coming back for check-ups, and your health will be monitored closely. Ultimately, the findings from this study aim to help shape future TB treatment programs by highlighting the importance of nutrition in recovery.
Gender
ALL
Eligibility criteria
- 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
About Boston Medical Center
Boston Medical Center (BMC) is a leading academic medical center located in Boston, Massachusetts, dedicated to providing high-quality, compassionate care to diverse populations. As a prominent clinical trial sponsor, BMC conducts innovative research aimed at advancing medical knowledge and improving patient outcomes across a wide range of specialties. With a commitment to health equity and access to care, BMC collaborates with various stakeholders, including academic institutions and industry partners, to facilitate groundbreaking studies and translate findings into effective treatments. Its robust infrastructure and experienced research teams ensure adherence to the highest ethical standards and regulatory compliance in all clinical trials.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Porto Novo, , Benin
Lomé, , Togo
Patients applied
Trial Officials
Pranay Sinha, MD
Principal Investigator
Boston Medical Center
Kobto G Khoura, MD, PhD
Study Director
The International Union Against Tuberculosis and Lung Disease
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported