Clinical trial NCT06084715: The INSTITUT Study
Official title: Impact of Nutritional Support for Tuberculosis on Intermediate and Terminal Undernutrition and Treatment Outcomes: the INSTITUT Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tuberculosis, Pulmonary
Undernutrition
Keywords: Persons with TB (PWTB)
Nutritional support
Republic of Benin
Togolese Republic
Treatment failure
TB relapse
Chronic obstructive pulmonary disease (COPD)
Quality of life
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: The International Union Against Tuberculosis and Lung Disease
First posted: 2023-10-16
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1050 participants will be enrolled and followed for approximately 12 months. 700 will be enrolled in Benin and 350 in Togo. Participants enrolled in Benin will receive nutritional support from the hospital while those enrolled in Togo will not.

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 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.

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 status of persons with TB (PWTB) at the end of treatment.

Pulmonary TB patients who meet eligibility criteria including being diagnosed with a smear-positive (\>/=1+ AFB) and provide informed consent will be enrolled. A projected sample of 1050 participants will be enrolled and followed for approximately 12 months. 700 will be enrolled in Benin and 350 in Togo. Participants enrolled in Benin will receive nutritional support from the hospital while those enrolled in Togo will not.

Sputum samples will be collected at baseline and month two to confirm diagnosis and resolution of disease. Chest X-rays will be taken at enrollment, if not available by the TB program, and repeated 6 months following the end of TB treatment to assess for post-TB chronic lung disease. At all visits, surveys will be administered to assess for response to treatment and functional and economic recovery.

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

Primary outcomes:
measure: Percent of participants with an unfavorable outcome
timeFrame: 12 months
Secondary outcomes:
measure: Number of participants with failure of sputum conversion
timeFrame: 2 months
Other outcomes:
measure: Number of participants lost to follow up during therapy
timeFrame: 6 months
Locations:
city: Porto-Novo
country: Benin
facility: Centre Hospitalier et Universitaire de Pneumo-phtisiologie
city: Lomé
country: Togo
facility: National Tuberculosis Programme
Study officials:
affiliation: Boston Medical Center
name: Pranay Sinha, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The International Union Against Tuberculosis and Lung Disease
name: Kobto G Khoura, MD, PhD
role: STUDY_DIRECTOR
References: