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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Benin
Centre Hospitalier et Universitaire de Pneumo-phtisiologie
RECRUITING
Porto-novo
Togo
National Tuberculosis Programme
RECRUITING
Lomé
Contact Information
Primary
Pranay Sinha, MD
pranay.sinha@bmc.org
617 414 3789
Backup
Madolyn Dauphinais, MPH
madolyn.dauphinais@bmc.org
617 414 3789
Time Frame
Start Date: 2023-09-07
Estimated Completion Date: 2025-12
Participants
Target number of participants: 1050
Treatments
Nutritional support group
Participants in this group will be enrolled in Benin and will receive nutritional support from the hospital where they receive care. They will be followed for 12 months.
Standard of care group
Participants in this group will be enrolled in Togo and will not receive nutritional support from the hospital where they receive care. They will be followed for 12 months.
Related Therapeutic Areas
Sponsors
Leads: Boston Medical Center
Collaborators: The International Union Against Tuberculosis and Lung Disease

This content was sourced from clinicaltrials.gov