Antibiotics vs Corticosteroids in Treatment of Granulomatous Lobular Mastitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Steroid, Antibiotic.
- Who it may be relevant to
- Registry conditions: Granulomatous Mastitis. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Antibiotics vs Corticosteroids in Treatment of Granulomatous Lobular Mastitis - A Randomized Controlled Trail
Overview
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.
Detailed description
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
Interventions
- Drug 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 - Drug 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
Primary outcome measures
- Primary outcome [Time frame: 2 months]
Secondary outcome measures (11)
- To assess the safety and tolerability of each treatment regimen [Time frame: 2 months]
- To assess the the proportion of patients requiring surgery in the treatment of GLM [Time frame: 2 months]
- To assess the role of different quantum of surgery needed (Incision and Drainage/Resection/mastectomy) in the treatment of GLM [Time frame: 2 months]
- To assess the number of patients have recurrence after surgery in the treatment of GLM [Time frame: 2 months]
- To assess the number of patients requiring Aspiration/ minisuction drain(6 french aspiration catheter/pigtail) in the treatment of GLM [Time frame: 2 months]
- To assess the failure rate of aspiration/ minisuction drain(6 french aspiration catheter/pigtail) in the treatment of GLM [Time frame: 2 months]
- To determine the Indications of immunosuppressive therapy in the treatment of GLM [Time frame: 2 months]
- To To determine the proportion of patient requiring combination immunosuppressive therapy in the treatment of GLM [Time frame: 2 months]
- To determine the average duration of immunosuppressive therapy required in the treatment of GLM [Time frame: 2 months]
- Histological pattern (neutrophilic/lymphocytic/mixed) [Time frame: 2 months]
- Proportion of CCR obtained in each histological pattern (neutrophilic/lymphocytic) [Time frame: 2 months]
Eligibility criteria
Inclusion criteria
- Women histologically diagnosed with GLM willing to participate in the study and to come for follow up.
Exclusion criteria
- Declining to participate in the study
- Pregnant or lactating women
- Patient already on antibiotic/steroid therapy and are responding to treatment
- Known immunosuppression or diabetes mellitus uncontrolled
- Patient already on immunosuppression therapy for any other disorder
- Lost to follow-up before 3 months post-treatment
- Allergic to one of the antibiotics/steroids which will be used
- Contraindications to oral steroids therapy
- Contraindications to methotrexate therapy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
India · 1 center
- AIIMS Bhubaneswar — Bhubaneswar
Identifiers
NCT: NCT07454772 · ECR/534/inst/OD/2014/RR-25