Open-Label Assessment of the Efficacy of Atrantil In the Treatment of Methane-Predominate Intestinal Bacterial Overgrowth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in clinical symptoms of Intestinal Methane Overgrowth as measured by the Bristol Stool Scale (BSS)
研究概览
简要总结
Intestinal Bacterial Overgrowth (IBO) is a common functional condition due to excessive amounts of bacteria in the gastrointestinal tract. These bacteria ferment ingested food resulting in the production of hydrogen, methane, and carbon dioxide which subsequently can induce GI symptoms including abdominal pain, bloating, distention, diarrhea and constipation. Typically this condition is treated with antibiotics but for a portion of patients symptoms often recur. Recent work suggests that increased methane production may emanate from overgrowth of a specific type of archaebacteria, causing the aforementioned symptoms. However, no current therapies exist to treat this phenomenon. The investigators propose to trial the supplement Atrantil on patients with IMO in order to study the supplements impact on symptoms, quality of life, and methane levels.
详细描述
Intestinal microbial overgrowth is associated with multiple gastrointestinal symptoms. Most prevalent are gas-related symptoms (i.e. bloating, distention, increased flatus, constipation)
. Intestinal microbial overgrowth can currently be divided into two main subcategories: small intestinal bacterial overgrowth (SIBO) and intestinal methanogenic overgrowth (IMO). Both are most commonly detected via breath testing-a simple non-invasive study
- Despite the increasing prevalence of this disorder few evidence-based therapeutics currently exist. SIBO, identified by elevations in breath hydrogen, has been shown to respond to treatment with antibiotics including rifaximin and doxycycline in clinical trials
- However, IMO, detected by elevations in breath methane is a different disorder attributed to overgrowth of archaea which reside predominately in the colon
- Currently, there are no evidence-based treatments for IMO, and the American College of Gastroenterology guideline on the diagnosis and treatment of SIBO makes no specific recommendations regarding the treatment of this disorder.
Atrantil is a medical food composed of peppermint, quebracho tree bark, and horse chestnut.
These components are purported to reduce methane production, scavenge hydrogen (thus reducing the building blocks for methane), and potentially act as a cidal agent for methanogenic archaea. In a small randomized controlled-trial, Atrantil reduced bloating and constipation in a population of individuals with irritable bowel syndrome with constipation (IBS-C)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Participants must be able to provide informed consent
- •Participants must be able to attend study visits
- •Participants aged 18 years or greater
- •Must have a diagnosis of Intestinal Methane Overgrowth based on North American Consensus/American College of Gastroenterology established cutoffs
- •Participants must report current symptoms of bloating, distention, abdominal pain, abdominal discomfort and constipation
- •Participant must be an established patient at Northwestern Memorial Hospital
排除标准
- •Participants who are already taking Atrantil
- •Participants who are pregnant or breast-feeding
- •Participants who cannot tolerate or are unwilling to complete a hydrogen-methane breath test at week
- •Inability to attend all study visits and complete survey data.
结局指标
主要结局
Change in clinical symptoms of Intestinal Methane Overgrowth as measured by the Bristol Stool Scale (BSS)
时间窗: Change from Baseline at four weeks.
BSS is a clinical tool that divides feces into 7 categories along the continuum severe constipation to severe diarrhea to demonstrate the effectiveness of a treatment
Change in clinical symptoms of Intestinal Methane Overgrowth as measured by daily Numeric Rating Scale (NRS) measuring pain, bloating, distention, and discomfort.
时间窗: Daily for 28 days
Numeric Rating Scale is a four-item scale measuring the severity of pain, bloating, distention, and discomfort on a scale of 1 to 10 for each measure. Higher scores indicate a higher level of symptom severity. Lower scores indicate a lower level of symptom severity.
Change in clinical symptoms of Intestinal Methane Overgrowth as measured by Patient Reported Outcome Measures Information Systems Gastrointestinal Symptoms Scale (PROMIS-GI)
时间窗: Change from Baseline at four weeks.
PROMIS GI Scales is a collection of eight categories of GI-symptoms (Belly pain, Bowel Incontinence, Constipation, Diarrhea, Disrupted Swallowing, Gas and Bloating, Nausea and Vomiting, and Acid reflux) Higher scores indicate a higher level of symptom severity. Lower scores indicate a lower level of symptom severity.
次要结局
- Change in Quality of life as measured by the PROMIS-Global Health (PROMIS-GH)(Change from Baseline at four weeks.)
- Change in methane as measured by hydrogen methane breath-test pre and post-treatment.(Post-Treatment (+-3 days))
- Change in quality of life as measured by Short Form- 12.(Change from Baseline at four weeks.)
研究者
Darren Brenner
Associate Professor of Medicine and Surgery
Northwestern University