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Antibiotics vs Corticosteroids in Treatment of Granulomatous Lobular Mastitis

Study acronym: GRANMAS
StatusNot Yet Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
The goal of this clinical trial is to find the most effective and safe medical treatment for Granulomatous Lobular Mastitis (GLM) - a rare, chronic inflammatory breast disease that affects young and middle-aged women, often following childbirth. The main questions it aims to answer are: Does an antibiotic regimen (clarithromycin, ofloxacin, rifaximin) lead to faster and complete healing (Complete Clinical Response) compared to steroids? Do steroids (prednisolone in tapering doses) provide better symptom control or cause more side effects? Researchers will compare the antibiotic group (Group A) and the steroid group (Group B) to see which treatment results in quicker recovery, fewer side effects, and lower recurrence rates. Participants will: Receive a 14-day antibiotic trial initially (screening phase). If no improvement, be randomly assigned to: Group A (Antibiotic therapy) - Clarithromycin, Ofloxacin, Rifaximin for 8 weeks, or Group B (Steroid therapy) - Prednisolone in tapering doses for 8 weeks. Undergo evaluation after 2 months: If not fully recovered, receive Methotrexate + Folic acid for another 8 weeks. If still no improvement, switch to the alternate treatment or undergo surgery if required. Attend regular follow-ups for 6 months for clinical assessment and monitoring of side effects. This 2-year study aims to develop a standardized, step-by-step treatment protocol for GLM, helping improve outcomes and reduce unnecessary surgeries for affected women.
Trial Details
NCT Number NCT07454772
Lead Sponsor All India Institute of Medical Sciences, Bhubaneswar
Conditions
(from sponsor)
Granulomatous Mastitis
Related terms Granulomatous Mastitis
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov