Antibiotic Treatment Trial for Small Intestinal Bacterial Overgrowth: A Randomized, Double-Blind, Placebo-Controlled Trial Comparing Ciprofloxacin and Metronidazole
试验速览
- 阶段
- 4 期
- 入组人数
- 180
- 主要终点
- Number of patients cured of SIBO after treatment with ciprofloxacin versus metronidazole versus placebo.
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy of ciprofloxacin versus metronidazole versus placebo in eradication of small intestinal bacterial overgrowth (SIBO).
详细描述
Approximately 180 study subjects with SIBO identified by positive glucose hydrogen breath (GHB) testing who meet inclusive and exclusive criteria will be randomized to receive either ciprofloxacin 500mg by mouth twice daily, metronidazole 500mg by mouth twice daily, or placebo by mouth twice daily. Subjects will complete a baseline symptom questionnaire and be treated for 14 days. Response will be assessed at end of treatment. The Gastrointestinal Symptom Rating Scale (GSRS) and GHB testing will be performed at the end of treatment. Subjects with a negative GHB at the end of treatment are considered as cured, or treatment success. Patients with treatment success will be reassessed for long-term response to treatment or disease recurrence at 30 days, 4 months, and 9 months using GHB. Symptoms will also be re-assessed at the 30 day, 4 month, and 9 month intervals with GSRS-IBS symptom questionnaire done prior to GHB testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients age greater than 18 who have been diagnosed with SIBO after a clinically indicated hydrogen breath test.
- •Patients with liver disease or liver cirrhosis will be included, as this particular group is at higher risk for developing SIBO, would potentially benefit from inclusion, and do not require dose adjustments with either study medication.
- •Patients on warfarin are not excluded, but INR will be uniformly recommended to be checked within 1 week of therapy initiation, as standard practice through the Coumadin clinic, for the potential effect on INR and increased risk of bleeding while on any antibiotic
排除标准
- •Patient age less than 18
- •Hypersensitivity to the antibiotics
- •Pregnancy or breast feeding
- •Patients who cannot consent for themselves
- •End stage renal disease defined as creatinine clearance <30 mL/min or on hemodialysis.
- •Patients who have taken antibiotics in the past 30 days
- •Laxatives, stool softeners, or bulk fiber in the last 7 days
- •Enemas or suppositories in the last 3 daysⱡ
研究组 & 干预措施
Placebo
Placebo capsule:
To be provided by BAMC Pharmacy. It will be made and stored by BAMC pharmacy. The matching placebo will be a gelatin capsule filled with methylcellulose powder only. Patient will take 2 capsules two times a day for 14 days.
干预措施: Placebo (Drug)
Ciprofloxacin
Ciprofloxacin 250mg capsule:
To be provided by BAMC pharmacy. It will be made and stored by BAMC Pharmacy. Ciprofloxacin 250mg tablet will be encapsulated with a gelatin capsule filled with methylcellulose. Patient will take 2 capsules of Ciprofloxacin 250mg two times a day for 14 days.
干预措施: Ciprofloxacin (Drug)
Metronidazole
Metronidazole 250mg capsule:
To be provided by BAMC pharmacy. It will be made and stored by BAMC Pharmacy. Metronidazole 250mg will be encapsulated with a gelatin capsule filled with methylcellulose. Patient will take 2 capsules of metronidazole 250mg two times a day for 14 days.
干预措施: Metronidazole (Drug)
结局指标
主要结局
Number of patients cured of SIBO after treatment with ciprofloxacin versus metronidazole versus placebo.
时间窗: 2 weeks
次要结局
- Disease relapse rate of SIBO after treatment success(Immediately post-treatment (approximately 2 weeks), 30 days, 4 months, and 9 months)
- Time interval between treatment success and recurrence of SIBO(Immediately post-treatment (approximately 2 weeks), 30 days, 4 months, and 9 months)
- Gastrointestinal symptoms based on questionnaire(Immediately post-treatment (approximately 2 weeks), 30 days, 4 months, and 9 months)
研究者
Karin S. Gilkison
Gastroenterology Fellow
San Antonio Military Medical Center