A Randomized Open Label Trial Evaluating the Efficacy of AEMCOLO (Rifamycin SV MMX) in the Treatment of Small Intestinal Bacterial Overgrowth (SIBO)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To assess the change of an abnormal breath test followed by a regimen of AEMCOLO
研究概览
简要总结
Open label interventional randomized pilot study utilizing two dosing regimens of AEMCOLO. The goal of this study is to evaluate effectiveness of a novel antibiotic, AEMCOLO (Rifamycin SV MMX) in the treatment of Small intestinal bacterial overgrowth (SIBO).
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Symptoms compatible with SIBO
- •A positive breath test for either hydrogen predominant, methane predominant or mixed SIBO
排除标准
- •History of diabetes mellitus,
- •Diarrhea predominant irritable bowel syndrome (IBS-D),
- •Symptomatic bowel obstruction,
- •Diverticulitis and/ or adhesions,
- •Autoimmune disorder,
- •Immunosuppression by medication or disease,
- •Pregnant or breast feeding,
- •The use of antibiotics, probiotics or prebiotics within the previous 30 days,
- •Known hypersensitivity to rifamycin, any of the other rifamycin class antimicrobial agents (e.g. rifaximin), or any of the components of AEMCOLO.
研究组 & 干预措施
1st regimen
15 patients will receive AEMCOLO (Rifamycin SV MMX) 194 mg two tablets to take twice daily for 14 days (56 Tablets)
干预措施: AEMCOLO (Rifamycin SV MMX) (Drug)
2nd regimen
15 patients will receive AEMCOLO (Rifamycin SV MMX) 194 mg tablets to take two tablets three times daily for 14 days (84 Tablets).
干预措施: AEMCOLO (Rifamycin SV MMX) (Drug)
结局指标
主要结局
To assess the change of an abnormal breath test followed by a regimen of AEMCOLO
时间窗: 1 month after treatment
A hydrogen and methane breath test will be used to measure presence or absence of Small Intestinal Bacterial Overgrowth (SIBO). Study subjects will be assessed for the presence of SIBO. A rise of ≥ 20 ppm from baseline in hydrogen by 90 minutes or a level of ≥ 10 ppm for methane is considered a positive test for SIBO on a breath test. When combining both hydrogen and methane in the breath test, a rise of ≥ 15 ppm from baseline at 90 minutes is considered a positive test for SIBO. We plan to measure these parameters at baseline and after completion of study medication.
次要结局
- To evaluate the change in clinical symptoms followed by a regimen of AEMCOLO(Daily survey during and after treatment for 2 months and follow up at 3 months)
研究者
Bradley Connor
Principal Investigator
The New York Center for Travel and Tropical Medicine