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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06084715




Registration number
NCT06084715
Ethics application status
Date submitted
5/10/2023
Date registered
16/10/2023
Date last updated
1/10/2024

Titles & IDs
Public title
The INSTITUT Study
Scientific title
Impact of Nutritional Support for Tuberculosis on Intermediate and Terminal Undernutrition and Treatment Outcomes: the INSTITUT Study
Secondary ID [1] 0 0
H-43096
Universal Trial Number (UTN)
Trial acronym
INSTITUT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tuberculosis, Pulmonary 0 0
Undernutrition 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Nutritional support

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.

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.


Other interventions: Nutritional support
The hospitals in Benin already provide nutritional support for patients with pulmonary TB which will continue throughout the study.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent of participants with an unfavorable outcome
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Number of participants with failure of sputum conversion
Timepoint [1] 0 0
2 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
1050
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Benin
State/province [1] 0 0
Porto-Novo
Country [2] 0 0
Togo
State/province [2] 0 0
Lomé

Funding & Sponsors
Primary sponsor type
Other
Name
Boston Medical Center
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The International Union Against Tuberculosis and Lung Disease
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06084715
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Pranay Sinha, MD
Address 0 0
Boston Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pranay Sinha, MD
Address 0 0
Country 0 0
Phone 0 0
617 414 3789
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06084715