The INSTITUT Study

Last updated: September 30, 2024
Sponsor: Boston Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Disease

Hiv

Diet And Nutrition

Treatment

Nutritional support

Clinical Study ID

NCT06084715
H-43096
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Drug susceptible, Xpert [polymerase chain reaction (PCR) test for TB] positiveand/or sputum stain positive for AFB (≥1+)

  • Willing to attend follow-up visits and undergo study procedures

Exclusion

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 asa 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 topre-existing mobility issues due to disability, trauma, neurological compromise, orcardiopulmonary issues

Study Design

Total Participants: 1050
Treatment Group(s): 1
Primary Treatment: Nutritional support
Phase:
Study Start date:
September 07, 2023
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Centre Hospitalier et Universitaire de Pneumo-phtisiologie

    Porto-Novo,
    Benin

    Active - Recruiting

  • National Tuberculosis Programme

    Lomé,
    Togo

    Active - Recruiting

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