Antibiotics vs Corticosteroids in Treatment of Granulomatous Lobular Mastitis

What is this study about?

This research is being done at AIIMS Bhubaneswar to find the best medical treatment for a breast condition called Granulomatous Lobular Mastitis (GLM).

GLM is a rare, long-lasting inflammation of the breast that mainly affects young and middle-aged women, often those who have recently had children. It can look very similar to breast cancer or a breast abscess, causing anxiety and sometimes unnecessary surgery.

Common symptoms include:

Painful or painless breast lump

Swelling, redness, or abscess (collection of pus)

Discharge from the nipple or retraction (nipple pulled inward)

Skin changes over the breast It can occur in one or both breasts and may come back after treatment.

Why is this study important?

At present, there is no single, standard treatment for GLM. Doctors use antibiotics, steroids, immunosuppressants (like methotrexate), or surgery - but the results vary widely. Some medicines help one patient but not another, and some cause unwanted side effects or recurrences.

This study aims to compare antibiotics and steroids directly, to identify which gives better and faster healing with fewer side effects. The goal is to develop a clear, step-by-step treatment plan for all patients with GLM.

What will happen in this study? Who can take part?

Women diagnosed with GLM by biopsy (tissue test).

Participants must be willing to attend regular follow-ups.

Women who are pregnant, breastfeeding, diabetic (uncontrolled), on other immunosuppressive treatment, or allergic to study drugs cannot participate.

How the study works:

First step (screening):

All participants will receive a short course of antibiotics for 14 days.

If the infection improves, treatment continues outside the study.

If it doesn't improve, the person will be included in the main trial.

Random assignment:

Patients will be randomly divided into two groups:

Group A - Antibiotic group: Receives clarithromycin, ofloxacin, and rifaximin tablets for 8 weeks.

Group B - Steroid group: Receives prednisolone (steroid tablets) in reducing doses for 8 weeks.

Review after 2 months:

Doctors will check whether the breast swelling and pain are gone.

If completely cured (called Complete Clinical Response or CCR), medicines are stopped.

If not cured, the patient is given an additional medicine (methotrexate + folic acid) for 8 weeks.

If still not improved:

The treatment groups are switched (antibiotic patients receive steroids, and vice versa).

If there's still no recovery, surgery (like abscess drainage or lump removal) will be considered.

Throughout the study, symptoms, side effects, and any need for surgery will be recorded carefully.

How long does participation last?

Each participant will be followed for around 6 months - this includes treatment, monitoring, and follow-up visits.

Possible benefits for participants

Regular medical check-ups, follow-ups, and investigations by specialist doctors.

Chance of receiving an effective, well-monitored treatment plan.

Early detection of complications and quick medical management.

Contribution to medical knowledge that may help future patients avoid prolonged or incorrect treatment.

Possible side effects or risks

• To assess the safety and tolerability of each treatment regimen [Срок оценки: 2 months]
• To assess the the proportion of patients requiring surgery in the treatment of GLM [Срок оценки: 2 months]
• To assess the role of different quantum of surgery needed (Incision and Drainage/Resection/mastectomy) in the treatment of GLM [Срок оценки: 2 months]
• To assess the number of patients have recurrence after surgery in the treatment of GLM [Срок оценки: 2 months]
• To assess the number of patients requiring Aspiration/ minisuction drain(6 french aspiration catheter/pigtail) in the treatment of GLM [Срок оценки: 2 months]
• To assess the failure rate of aspiration/ minisuction drain(6 french aspiration catheter/pigtail) in the treatment of GLM [Срок оценки: 2 months]
• To determine the Indications of immunosuppressive therapy in the treatment of GLM [Срок оценки: 2 months]
• To To determine the proportion of patient requiring combination immunosuppressive therapy in the treatment of GLM [Срок оценки: 2 months]
• To determine the average duration of immunosuppressive therapy required in the treatment of GLM [Срок оценки: 2 months]
• Histological pattern (neutrophilic/lymphocytic/mixed) [Срок оценки: 2 months]
• Proportion of CCR obtained in each histological pattern (neutrophilic/lymphocytic) [Срок оценки: 2 months]