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

BACKGROUND: The optimal duration of treatment for intestinal tuberculosis (TB), which remains a common disease worldwide, has not yet been established. The proposed randomized controlled study will aim to compare the efficacy of short-term six-month with nine-month anti-TB therapy for treating intestinal TB. METHODS: This multicenter, open-label, double-blinded, randomized controlled trial conducted in the Affiliated Hangzhou Chest Hospital of Zhejiang University will include a total of 80 patients. Patients who meet the inclusion criteria will be randomly assigned to either the six-month (n=40) or nine-month (n=40) treatment group. The primary outcome will be complete response, which is defined as endoscopy displaying active lesion healing at the end of treatment. Participants will be scheduled for follow-up visits once a month in the first three months, then once every three months until the end of the treatment. The last follow-up will be one year after the treatment. Recurrence will be assessed one year after the end of treatment, which is defined as endoscopy displaying recurrent lesions after complete response. DISCUSSION: In addition to the reports of tuberculous lymphadenitis and spinal TB, there are few appropriate randomized trials for the treatment of extrapulmonary TB with appropriate clinical endpoints. We believe that the proposed randomized controlled trial will provide further data on the efficacy of short-term six-month anti-TB therapy in intestinal TB patients. TRIAL REGISTRATION: This trial will be registered on ClinicalTrial.gov.