Impact of nutritional support on tuberculosis treatment outcomes
Impact of Nutritional Support for Tuberculosis on Intermediate and Terminal Undernutrition and Treatment Outcomes: the INSTITUT Study
This study is testing if giving nutritional support to people with tuberculosis in Benin helps them recover better compared to those in Togo who don’t receive that support.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1050 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston Medical Center Academic / other |
| Locations | 2 sites (Porto-Novo and 1 other locations) |
| Trial ID | NCT06084715 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the effects of nutritional support on treatment outcomes for patients with tuberculosis (TB) in Benin and Togo. It will involve a prospective cohort analysis of 1,050 participants, with 700 receiving nutritional support in Benin and 350 serving as a control group in Togo without such support. The study will track treatment outcomes, including treatment failure and relapse, over a 12-month period, utilizing sputum samples and chest X-rays to assess disease resolution and lung health. The findings are expected to inform TB treatment programs in both countries.
Who should consider this trial
Good fit: Ideal candidates include drug-susceptible, smear-positive TB patients who can provide informed consent and attend follow-up visits.
Not a fit: Patients with drug-resistant TB or those too ill to enroll will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes for tuberculosis patients through enhanced nutritional support.
How similar studies have performed: Other studies have indicated the importance of nutritional support in TB treatment, suggesting that this approach may yield beneficial results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Porto-Novo and 1 other locations
- Centre Hospitalier et Universitaire de Pneumo-phtisiologie — Porto-Novo, Benin (Recruiting)
- National Tuberculosis Programme — Lomé, Togo (Recruiting)
Study contacts
- Principal investigator: Pranay Sinha, MD — Boston Medical Center
- Study coordinator: Pranay Sinha, MD
- Email: pranay.sinha@bmc.org
- Phone: 617 414 3789
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.