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Search / Trial NCT06084715

The INSTITUT Study

Launched by BOSTON MEDICAL CENTER · Oct 12, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Persons With Tb (Pwtb) Nutritional Support Republic Of Benin Togolese Republic Treatment Failure Tb Relapse Chronic Obstructive Pulmonary Disease (Copd) Quality Of Life

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.

Locations

Porto Novo, , Benin

Lomé, , Togo

Patients applied

0 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