The INSTITUT Study Tuberculosis Nutritional Support

NCT06084715 | Completed

• 1 other identifier: H-43096
• Study Type: observational
• Target: 769
• Locations: 2 countries
• Sites: 2

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.

Conditions

Tuberculosis, Pulmonary; Undernutrition

Keywords

Persons with TB (PWTB); Nutritional support; Republic of Benin; Togolese Republic; Treatment failure; TB relapse; Chronic obstructive pulmonary disease (COPD); Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants with failure of sputum conversion

  2 months

Other Outcomes (1)

• Number of participants lost to follow up during therapy

  6 months

Study Arms (2)

Nutritional support group

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.

Other: Nutritional support

Standard of care group

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.

Interventions

Nutritional support OTHER

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

Nutritional support group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead
• The International Union Against Tuberculosis and Lung Disease: collaborator

Study Sites (2)

Centre Hospitalier et Universitaire de Pneumo-phtisiologie

Porto-Novo, Benin

Location

National Tuberculosis Programme

Lomé, Togo

Location

Related Publications (1)

• Cintron C, Dauphinais M, Fiogbe AA, Dogo MF, Ate S, Adjonou C, Agossou K, Pan SJ, Esse M, Ade B, Adjoh KS, Affolabi D, Sinha P, Koura KG. Impact of Nutritional Support for Tuberculosis on Intermediate and Terminal Undernutrition and Treatment Outcomes (INSTITUT) study: a protocol for a quasi-experimental study to assess the impact of nutritional support on tuberculosis treatment outcomes in Benin and Togo. BMJ Open. 2025 Feb 10;15(2):e088629. doi: 10.1136/bmjopen-2024-088629.

  PMID: 39929516 DERIVED

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Malnutrition; Pulmonary Disease, Chronic Obstructive

Interventions

Nutritional Support

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Pranay Sinha, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

• Kobto G Khoura, MD, PhD

  The International Union Against Tuberculosis and Lung Disease

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 16, 2023
• Study Start: September 7, 2023
• Primary Completion: September 10, 2025
• Study Completion: September 21, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); TO (1)