Antibiotics vs Corticosteroids in Treatment of Granulomatous Lobular Mastitis
GRANMAS
1 other identifier
interventional
72
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2025
CompletedFirst Posted
Study publicly available on registry
March 6, 2026
CompletedStudy Start
First participant enrolled
March 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 4, 2027
March 6, 2026
February 1, 2026
1.1 years
November 17, 2025
March 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Primary outcome
To compare the efficacy of antibiotics vs corticosteroids in achieving Complete Clinical Response (CCR) via clinical and radiological assessment in GLM patients at two months of the treatment started in the adaptive randomized arm. CCR will be defined as no clinical signs and symptoms of the disease and no recurrence for 6 weeks.
2 months
Secondary Outcomes (11)
To assess the safety and tolerability of each treatment regimen
2 months
To assess the the proportion of patients requiring surgery in the treatment of GLM
2 months
To assess the role of different quantum of surgery needed (Incision and Drainage/Resection/mastectomy) in the treatment of GLM
2 months
To assess the number of patients have recurrence after surgery in the treatment of GLM
2 months
To assess the number of patients requiring Aspiration/ minisuction drain(6 french aspiration catheter/pigtail) in the treatment of GLM
2 months
- +6 more secondary outcomes
Study Arms (2)
ARM Corticosteroid
ACTIVE COMPARATORSteroids are used to treat GLM
ARM Antibiotic
ACTIVE COMPARATORAntibiotics are used to treat GLM
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- Women histologically diagnosed with GLM willing to participate in the study and to come for follow up.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AIIMS Bhubaneswar
Bhubaneswar, Odisha, 751019, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tushar Subhadarshan Mishra, MBBS,MS
AIIMS Bhubaneswar
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Department, Department of General Surgery
Study Record Dates
First Submitted
November 17, 2025
First Posted
March 6, 2026
Study Start
March 15, 2026
Primary Completion (Estimated)
April 4, 2027
Study Completion (Estimated)
July 4, 2027
Last Updated
March 6, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share