Antibiotics vs Corticosteroids in Treatment of Granulomatous Lobular Mastitis - A Randomized Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
研究概览
简要总结
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:
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Receive a 14-day antibiotic trial initially (screening phase).
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If no improvement, be randomly assigned to:
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Group A (Antibiotic therapy) – Clarithromycin, Ofloxacin, Rifaximin for 8 weeks, or
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Group B (Steroid therapy) – Prednisolone in tapering doses for 8 weeks.
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Undergo evaluation after 2 months:
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If not fully recovered, receive Methotrexate + Folic acid for another 8 weeks.
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If still no improvement, switch to the alternate treatment or undergo surgery if required.
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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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women histologically diagnosed with GLM willing to participate in the study and to come for follow up.
排除标准
- •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.
研究者
Dr Tushar Subhadarshan Mishra
AIIMS Bhubaneswar