Tuberculosis, PulmonaryINSTITUTNCT06084715
The INSTITUT Study Tuberculosis Nutritional Support
An observational study of Tuberculosis, Pulmonary and Undernutrition, run by Boston Medical Center at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Pulmonary, Undernutrition
- What is being tested?
- Nutritional support
- How many people
- 769 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Sep 2023to 21 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Benin1 site
Centre Hospitalier et Universitaire de Pneumo-phtisiologie
Porto-Novo
Togo1 site
National Tuberculosis Programme
Lomé
About this study
Official title: Impact of Nutritional Support for Tuberculosis on Intermediate and Terminal Undernutrition and Treatment Outcomes: the INSTITUT Study
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.
Read the detailed 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.
- Conditions
- Tuberculosis, Pulmonary, Undernutrition
- Being tested
- Nutritional support
- Keywords
- Persons with TB (PWTB), Nutritional support, Republic of Benin, Togolese Republic, Treatment failure, TB relapse, Chronic obstructive pulmonary disease (COPD), Quality of life
- Medical subject headings
- Tuberculosis, Pulmonary, Malnutrition, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional supportOther
The hospitals in Benin already provide nutritional support for patients with pulmonary TB which will continue throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start7 Sep 2023
- Primary completion10 Sep 2025
- Study completion21 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 769 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- International Union Against Tuberculosis and Lung Diseases
- Responsible party
- Sponsor
- Investigators
- Pranay Sinha, MD, Principal investigator, Boston Medical CenterKobto G Khoura, MD, PhD, Study director, International Union Against Tuberculosis and Lung Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084715
- Sponsor's protocol ID
- H-43096
- Acronym
- INSTITUT
- Status last verified
- Nov 2025
- First submitted
- 5 Oct 2023
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39929516
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nutritional Support for Tuberculosis on Intermediate and Terminal Undernutrition and Treatment Outcomes: the INSTITUT Study
- ClinicalTrials.gov ID
- NCT06084715
- Acronym / sponsor ID
- INSTITUT / H-43096
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 769 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- International Union Against Tuberculosis and Lung Diseases
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 21 Sep 2025 (actual)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional support group | – | Other: Nutritional supportParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional supportThe hospitals in Benin already provide nutritional support for patients with pulmonary TB which will continue throughout the study. | Other | Nutritional support group |
Primary outcome
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.
1 secondary outcome
Number of participants with failure of sputum conversion
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Derived from this study: PubMed 39929516Cintron 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pranay Sinha, MD principal investigator
Boston Medical Center
Kobto G Khoura, MD, PhD study director
International Union Against Tuberculosis and Lung Diseases
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, Pulmonary and Undernutrition, run by Boston Medical Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Benin, Togo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of participants with an unfavorable outcome (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06084715, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.