The INSTITUT Study

Tuberculosis, Pulmonary Clinical Trial

— INSTITUT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06084715
• Other study ID #: H-43096
• Status: Recruiting
• Start date: September 7, 2023
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: Boston Medical Center
• Contact: Pranay Sinha, MD
• Phone: 617 414 3789
• Email: pranay.sinha[@]bmc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1050
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Tuberculosis
• Tuberculosis, Pulmonary
• Undernutrition

Intervention

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

Locations

Country	Name	City	State
Benin	Centre Hospitalier et Universitaire de Pneumo-phtisiologie	Porto-Novo
Togo	National Tuberculosis Programme	Lomé

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	The International Union Against Tuberculosis and Lung Disease

Countries where clinical trial is conducted

Benin,  Togo, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants lost to follow up during therapy	Lost to follow up is defined as discontinuing treatment for two or more consecutive months (8 weeks) for non-medical reasons.	6 months
Primary	Percent of participants with an unfavorable outcome	An unfavorable outcome will be a composite of TB treatment failure, death, or relapse based on patient evaluation 6 months after treatment completion.	12 months
Secondary	Number of participants with failure of sputum conversion	Failure for those with positive sputum smears at treatment onset to convert to having negative sputum smears after 2 months of intensive therapy.	2 months