Pre-treatment With Azithromycin to Reduce Immunogenicity to Anti-Tumor Necrosis Factor-α Agents in Patients With Inflammatory Bowel Disease

• Status: Not yet recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This will be a randomized placebo-controlled trial in inflammatory bowel disease patients before initiation of anti-tumor necrosis factor-α (anti-TNF) therapy that aims to test the effect of a pre-treatment short course of azithromycin therapy on immunogenicity

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rambam Health Care Campus
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

• All consenting adult (≥18 years) IBD patients starting infliximab or adalimumab therapy.

Exclusion Criteria:

• Inclusion in another interventional study

• Patients who cannot provide informed consent and do not have a legal guardian

• Patients with perianal involvement that are expected to require antibiotic therapy for their disease

• Patients on chronic antibiotic therapy due to any cause

• Crohn's Disease complication requiring surgical treatment

• Planned/ongoing methotrexate co-therapy

• Pregnancy

• Patients who received azithromycin therapy in the previous year (we will not exclude prior use of other antibiotic therapy)