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Completed

NCT Number: NCT06084715

The INSTITUT Study Tuberculosis Nutritional Support

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.

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Key information

Conditions

Tuberculosis, Pulmonary Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Chronic Disease Disease Attributes Gram-Positive Bacterial Infections Infections Lung Diseases Lung Diseases, Obstructive Malnutrition Mycobacterium Infections Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis Undernutrition

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritional Support

Other

The hospitals in Benin already provide nutritional support for patients with pulmonary TB which will continue throughout the study.

Primary outcomes

  1. Percent of participants with an unfavorable outcome

    Time frame: 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 outcomes

  1. Number of participants with failure of sputum conversion

    Time frame: 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.

Other outcomes

  1. Number of participants lost to follow up during therapy

    Time frame: 6 months

    Lost to follow up is defined as discontinuing treatment for two or more consecutive months (8 weeks) for non-medical reasons.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • The International Union Against Tuberculosis and Lung Disease

Registry information

Official study title

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

Acronym: INSTITUT

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 16, 2023
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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