The INSTITUT Study

Recruiting

• Conditions: Tuberculosis, Pulmonary; Undernutrition
• Interventions: Other: Nutritional support

• Registration Number: NCT06084715
• Lead Sponsor: Boston Medical Center

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.

Study Timeline

• Study Start: 2023-09-07
• Study First Submitted: 2023-10-05
• Study First Submitted QC: 2023-10-12
• Study First Posted: 2023-10-16
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-01
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1050

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nutritional support group	Nutritional support	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.

Primary Outcome Measures

Name	Time	Method
Percent of participants with an unfavorable outcome	12 months	An unfavorable outcome will be a composite of TB treatment failure, death, or relapse based on patient evaluation 6 months after treatment completion.

Secondary Outcome Measures

Name	Time	Method
Number of participants with failure of sputum conversion	2 months	Failure for those with positive sputum smears at treatment onset to convert to having negative sputum smears after 2 months of intensive therapy.

Trial Locations

Locations (2)

Centre Hospitalier et Universitaire de Pneumo-phtisiologie; 🇧🇯 Porto-Novo, Benin

National Tuberculosis Programme; 🇹🇬 Lomé, Togo