The INSTITUT Study Tuberculosis Nutritional Support

Boston Medical Center (BMC)

Status: Completed

Conditions: Tuberculosis, Pulmonary; Undernutrition

Treatments: Other: Nutritional support

Study type: Observational

Funder types: Other

Identifiers

NCT06084715

H-43096

Details and patient eligibility

About

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.

Full 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.

Enrollment: 769 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

769 participants in 2 patient groups

Nutritional support group

Description:

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.

Treatment:

Other: Nutritional support

Standard of care group

Description:

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.