Six-month versus nine-month therapy for intestinal tuberculosis: a protocol for a randomized controlled study

Area of Science:

• Infectious Diseases
• Pulmonology
• Gastroenterology

Background:

• Intestinal tuberculosis (TB) is a prevalent global disease.
• The optimal treatment duration for intestinal TB is not established.
• Extrapulmonary TB research, including intestinal TB, lacks sufficient randomized trials with clinical endpoints.

Purpose of the Study:

• To compare the efficacy of a six-month anti-TB therapy regimen against a nine-month regimen for treating intestinal TB.
• To provide data on the effectiveness of shorter-term anti-TB therapy for intestinal TB.

Main Methods:

• A multicenter, open-label, double-blinded, randomized controlled trial involving 80 patients.
• Patients randomly assigned to either a six-month (n=40) or nine-month (n=40) treatment group.
• Primary outcome: complete response defined by endoscopic healing of active lesions; recurrence assessed one year post-treatment.

Main Results:

• Primary outcome data on complete response rates for both treatment durations are pending.
• Recurrence rates at one year post-treatment for both groups are pending.
• Follow-up includes monthly visits for the first three months, then quarterly, with a final assessment one year after treatment completion.

Conclusions:

• The study is expected to provide crucial data on the efficacy of a six-month treatment duration for intestinal TB.
• Findings will help establish optimal treatment guidelines for intestinal tuberculosis.
• This trial contributes to the limited evidence base for treating extrapulmonary TB.