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Antibiotics vs Corticosteroids in Treatment of Granulomatous Lobular Mastitis
Sponsor: All India Institute of Medical Sciences, Bhubaneswar
Summary
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.
Official title: Antibiotics vs Corticosteroids in Treatment of Granulomatous Lobular Mastitis - A Randomized Controlled Trail
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2026-03-15
Completion Date
2027-07-04
Last Updated
2026-03-06
Healthy Volunteers
No
Conditions
Interventions
Steroid
Once randomized into the steroid arm, oral therapy with Tab. Prednisolone 20mg BD will be given for 14days, Tab. Prednisolone 10mg BD will be given for 21 days, Tab. Prednisolone 5mg BD will be given for 14days and Tab. Prednisolone 2.5mg BD will be given for 7 days(tapering dose) will be used in this intervention compared to antibiotics which are used in other. If the rate of response to oral steroids is slow and therapy prolonged, intralesional steroids (Inj. Triamcinalone 40mg) will be given as deemed required.
Antibiotic
Once randomized into the antibiotic arm, dual oral antibiotic therapy with Ofloxacin 400mg and Clarithromycin 500mg will be used in this intervention compared to steroids which are used in other
Locations (1)
AIIMS Bhubaneswar
Bhubaneswar, Odisha, India