Antibiotics vs Corticosteroids in Treatment of Granulomatous Lobular Mastitis - A Randomized Controlled Trail
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Primary outcome
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:
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
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
研究组 & 干预措施
ARM Antibiotic
Antibiotics are used to treat GLM
干预措施: Antibiotic (Drug)
ARM Corticosteroid
Steroids are used to treat GLM
干预措施: Steroid (Drug)
结局指标
主要结局
Primary outcome
时间窗: 2 months
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.
次要结局
- To assess the number of patients requiring Aspiration/ minisuction drain(6 french aspiration catheter/pigtail) in the treatment of GLM(2 months)
- To assess the failure rate of aspiration/ minisuction drain(6 french aspiration catheter/pigtail) in the treatment of GLM(2 months)
- 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 determine the Indications of immunosuppressive therapy in the treatment of GLM(2 months)
- To To determine the proportion of patient requiring combination immunosuppressive therapy in the treatment of GLM(2 months)
- To determine the average duration of immunosuppressive therapy required in the treatment of GLM(2 months)
- Histological pattern (neutrophilic/lymphocytic/mixed)(2 months)
- Proportion of CCR obtained in each histological pattern (neutrophilic/lymphocytic)(2 months)
研究者
Tushar Subhadarshan Mishra
Head of the Department, Department of General Surgery
All India Institute of Medical Sciences, Bhubaneswar