Novel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Resolution of Irritable Bowel Syndrome
研究概览
简要总结
The purpose of this research is to study the added benefit of treating IBS symptoms with a medication called mirtazapine in treating IBS symptoms when paired with a low-FODMAP diet compared to a low-FODMAP diet alone. FODMAP stands for fermentable oligosaccharides, disaccharides, monosaccharides, and polyols. These are short-chain carbohydrates that can cause digestive distress in some people.
You have been asked to take part in this research because you have symptoms of diarrhea-predominant irritable bowel syndrome that may respond to treatment with a combination of a medication called mirtazapine and a low-FODMAP diet.
详细描述
We hypothesize that adult patients with IBS-D treated with a combination of a low FODMAP diet and mirtazapine will have a greater improvement in global IBS symptoms including abdominal pain and diarrhea in addition to improved quality of life compared to those treated with a low-FODMAP diet only. Global improvement in IBS symptoms will be evaluated using the validated IBS-SSS questionnaire. We will evaluate changes in quality of life using a validated IBS-QoL questionnaire. We will assess the improvement in abdominal pain using a numerical rating system and assess improvements in diarrhea using the Bristol stool form scale. We will assess responses to bloating using a Mayo bloating questionnaire forms. We will assess improvement in diarrhea using the Bristol stool form scale.
Improvement in anxiety and any other descriptive information as provided by patients including patients reporting impression of overall severity of symptoms at the beginning, middle, and end of study.
Irritable bowel syndrome (IBS) is a common gastrointestinal (GI) disorder that affects up to 10% of the United States adult population. IBS is characterized by recurrent abdominal pain and altered bowel habits, diagnosed using the Rome IV criteria. Approximately one-third of all IBS patients are classified as having IBS with diarrhea (IBS-D), which has no validated treatment algorithm. The American College of Gastroenterology IBS guideline recommends the low-FODMAP (fermentable oligo-, di-, monosaccharide, and polyol) diet as a safe and modestly effective treatment. An analysis of 7 randomized, controlled trials found that the low-FODMAP diet was associated with an improvement in global IBS symptoms. However, despite following the low-FODMAP diet, many patients have persistent abdominal pain, which can be difficult to treat. The mechanisms underlying chronic abdominal pain in patients with IBS are unknown, although visceral and central hypersensitivity are thought to play a role. No medication is FDA-approved for the treatment of abdominal pain in IBS. Mirtazapine is an atypical antidepressant that acts on several classes of receptors. In a small open-label study mirtazapine improved IBS-D symptoms, including abdominal pain.
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
- Double (Participant, 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
- 否
入选标准
- •Participants must meet all of the inclusion criteria to participate in this study:
- •Adults (ages 18-70)
- •Score of >175 on the IBS-SSS questionnaire
- •Must meet Rome IV criteria for IBS-D
- •If subject is of reproductive capability a negative urine pregnancy test must be available prior to entering the study
- •Ability to understand study procedures and to comply with them for the entire length of the study
排除标准
- •All candidates meeting any of the below exclusion criteria at baseline will be excluded from study participation:
- •Score of < 175 on the IBS-SSS
- •Prior diagnoses of: known celiac disease, small intestinal bacterial overgrowth, inflammatory bowel disease, or microscopic colitis
- •Ongoing significant anxiety or depression
- •A history of a known side effect to mirtazapine
- •Prior treatment with a low FODMAP diet or mirtazapine without clinical benefit
- •Active alcohol or drug abuse
- •Inability to read or understand the consent form
- •Any other medical or psychological reason that would prevent active participation in a research study
- •Pregnant females
研究组 & 干预措施
Mirtazapine Group
Subjects will present at Mayo Clinic through a doctor's appointment and a diagnosis of irritable bowel syndrome will be receiving mirtazapine by pill form.
干预措施: Mirtazapine (Drug)
Placebo Group
Subjects will present at Mayo Clinic through a doctor's appointment and a diagnosis of irritable bowel syndrome will be receiving placebo by pill form.
干预措施: Placebo (Other)
结局指标
主要结局
Resolution of Irritable Bowel Syndrome
时间窗: 49 days
Evaluate global improvement in IBS symptoms using the validated IBS-SSS
Abdominal Pain Score
时间窗: 49 days
Assess improvement in abdominal pain using a numerical rating system
Stool Form Scale
时间窗: 49 days
Assess improvement in diarrhea using the Bristol stool form scale
Mayo Bloating Scale
时间窗: 49 days
Assess response to bloating using a validated Mayo bloating questionnaire
次要结局
未报告次要终点