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.
Women histologically diagnosed with GLM willing to participate in the study and to come for follow up.
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
Crossover
Steroid
DrugOnce 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
DrugOnce 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
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.
To assess the safety and tolerability of each treatment regimen
To assess the safety and tolerability of each treatment regimen via clinical assessment leading to the detection of any side effects, namely weight gain, skin changes, diabetes mellitus, bone pain, menstrual irregularities, hirsuitism, cataract, glaucoma, joint pains, tendonitis, skin ulcers, and heart rhythm changes. Any of the above side effects, debilitating enough to warrant stoppage of therapy will define tolerability. Development of irreversible side effects will define safety of the treatment regimen.
To assess the the proportion of patients requiring surgery in the treatment of GLM
Determining the proportion of patients requiring surgery, based on surgical procedures performed on basis of clinical examination findings suggestive of abscess. Aspiration and minisuction drain(6 french aspiration catheter/pigtail) will be not be considered as a surgical procedure
To assess the role of different quantum of surgery needed (Incision and Drainage/Resection/mastectomy) in the treatment of GLM
Determining the Quantum of surgery needed (Incision and Drainage/Resection/mastectomy), based on surgical procedures performed on basis of clinical examination findings suggestive of abscess. Aspiration and minisuction drain(6 french aspiration catheter/pigtail) will be not be considered as a surgical procedure
To assess the number of patients have recurrence after surgery in the treatment of GLM
Determining the number of patients have recurrence after surgery performed in the institution or outside, based on surgical procedures performed on basis of clinical examination findings suggestive of abscess. Aspiration and minisuction drain(6 french aspiration catheter/pigtail) will be not be considered as a surgical procedure
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This trial is not recruiting at the moment. You can still explore other options:
