NCT06084715Completed
The INSTITUT Study Tuberculosis Nutritional Support
Impact of Nutritional Support for Tuberculosis on Intermediate and Terminal Undernutrition and Treatment Outcomes: the INSTITUT Study
Source: ClinicalTrials.gov · Last updated 17 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 769 (actual)
- First submitted
- 5 Oct 2023
- Start date
- 7 Sept 2023
- Primary completion date
- 10 Sept 2025
- Lead sponsor
- Boston Medical Center
- Diseases
- Tuberculosis, COPD
- NCT number
- NCT06084715
What you commit to
- Study type: Observational
- Participants enrolled: 769
- From 7 Sept 2023 to the primary completion date, 10 Sept 2025
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Drug resistant TB
- Has received 7 or more days of antimicrobial therapy
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier et Universitaire de Pneumo-phtisiologie Coordinator of this site? Confirm its status | Porto-Novo | Benin | Unknown status |
| National Tuberculosis Programme Coordinator of this site? Confirm its status | Lomé | Togo | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.