Pilot Study: Investigating a Novel Supplement-based Therapy for the Treatment of Small Intestinal Bacterial Overgrowth
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Lactulose Breath Test
研究概览
简要总结
Study Synopsis
This pilot study will determine the efficacy of a novel supplement protocol and low FODMAP diet for the treatment of small intestinal bacterial overgrowth (SIBO). The study will operate as a prospective, open label investigation, with an estimated sample size of 10 patients.
Patients diagnosed with SIBO by Dr. Nathan Morris, MD at Good Medicine Clinic (Oxford, Ohio) will be offered the opportunity to enroll in this study, if inclusion and exclusion criteria are met upon initial diagnosis. No control group will be assigned.
The diagnosis of SIBO will be determined via assessment of clinical symptoms and the results of a lactulose breath test. After administration of the supplement therapy and adherence to a low FODMAP diet (8 weeks), the lactulose breath test will be repeated and symptoms re-assessed by Dr. Morris. The post-treatment lactulose breath test and all supplements in the protocol will be provided free-of-charge to enrolled patients. In addition, enrolled patients will not be billed for the mid-treatment office visit. Patient and/or patient insurance will be responsible for all other expenses, including but not limited to the initial breath test, all other office visits and travel.
详细描述
Background
Small intestinal bacterial overgrowth (SIBO) is a category of gastrointestinal infection, characterized by an increased concentration (>100,000 CFU/mL proximal jejunal fluid) of bacteria in the small intestine. Symptoms of SIBO commonly afflict the gastrointestinal tract and include but are not limited to: abdominal pain, discomfort, bloating, cramping, flatulence, diarrhea, constipation, eructation, and low serum B12.
SIBO is believed to be severely under diagnosed and is associated with numerous comorbid conditions including irritable bowel syndrome, diabetes mellitus and hypothyroidism. Small-bowel aspiration (SBA) or breath tests are used to aid in the diagnosis of SIBO. Glucose or lactulose breath tests are more commonly performed, due to the cost and invasive nature of SBA.
Treatment of SIBO frequently consists of antibiotic therapy. Rifaxamin is a poorly absorbed antibiotic with bacteriocidal activity against enteropathogens that is widely prescribed for the treatment of SIBO. However, both patients and practitioners frequently turn to complementary and alternative treatment options, due to the adverse effects associated with antibiotic use and the recurrent nature of SIBO. In 2014, a retrospective study (Chedid et al.) found that the efficacy of a particular herbal therapy was comparable to Rifaxamin. However, both treatment options demonstrated a response rate of less than 50%. This investigation will test a more comprehensive, supplement-based therapy in hopes of achieving a greater response rate in patients diagnosed with SIBO.
Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A positive diagnosis of SIBO, which will be defined by:
- •presentation of the aforementioned symptoms and
- •positive results of a lactulose breast test. Positive breath test results will be defined as an increase in hydrogen of 20 ppm or more and/or an increase in methane of 12 ppm or more compared to baseline by 90 minutes.
排除标准
- •Use of prescription antibiotics or antifungals within the past 4 weeks.
- •Younger than 18 or older than 85 years of age.
- •Pregnant or breastfeeding.
- •Major drug-supplement interactions between essential medication and the proposed supplement therapy.
- •A known allergy to one or more of the ingredients in the supplement therapy.
- •Has been diagnosed and treated for SIBO within the past 6 months.
- •Has undergone a colonoscopy or barium enema within the past 4 weeks.
- •Has an allergy to lactulose. 9) Has diabetes mellitus.
结局指标
主要结局
Lactulose Breath Test
时间窗: 8 weeks
Clinically and/or statistically significant reduction in hydrogen and methane levels following lactulose ingestion
次要结局
- Symptom Survey(8 weeks)