Crossover Trial of Gluten and Gluten With Amylase-trypsin Inhibitors as Triggers of Gastrointestinal Symptoms in Patients With Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Irritable Bowel Syndrome (IBS) symptoms
研究概览
简要总结
This crossover randomized controlled trial will evaluate the effects of gluten and gluten combined with amylase-trypsin inhibitors (ATIs) on inducing intestinal and extra-intestinal symptoms in irritable bowel syndrome (IBS) patients. All participants will be put on a gluten-free diet and then challenged with muesli bars containing either purified gluten, gluten with ATIs, or nocebo.
详细描述
Irritable bowel syndrome (IBS) is a heterogenous, common gastrointestinal disorder characterized by chronic abdominal pain and altered bowel habits. Many IBS patients report symptom relief on a gluten-free diet (GFD), but it is uncertain whether gluten is the true culprit. The gluten-containing grains wheat, rye, and barley all contain amylase-trypsin inhibitors (ATIs), and a GFD is virtually ATI-free.
This double-blinded crossover randomized controlled trial aims to determine which IBS patients are affected by pure gluten and which are affected by gluten combined with ATIs. IBS patients who respond to and have been on a GFD for 3+ weeks will be randomized to receive a dietary challenge of muesli bars containing either 1) pure gluten, 2) non-purified gluten (containing ATIs), 3) or nocebo for a week followed by a 14 day washout. This will be repeated until all participants have had each dietary challenge.
The study will evaluate the effects and potential mechanisms of purified and non-purified gluten on intestinal and extra-intestinal symptoms in IBS. It is likely that some IBS patients respond to gluten, while others respond to gluten combined with ATIs. Thus, this project may lead to better diagnosis and individualized dietary treatments for IBS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The statistician will also be masked from the treatments.
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
- •IBS diagnosis based on Rome IV criteria.
- •Asymptomatic on a gluten-free diet (IBS-SSS score 0-74).
- •Compliance with the study procedures (according to the investigator's own judgement).
- •Signing the Study Informed Consent form.
排除标准
- •Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection.
- •Concurrent organic gastrointestinal disease (i.e. Celiac disease, Inflammatory Bowel Disease, peptic ulcer disease, etc.) other than benign polyps, diverticulosis, hemorrhoids, lipoma and melanosis coli.
- •Major abdominal surgery with the exception of hernia repair, appendectomy, Caesarian section, tubal ligation, cholecystectomy, hysterectomy, and hemorrhoidectomy.
- •History of active cancer in the last 5 years, other than skin basal cells cancer.
- •Pregnant or breastfeeding women.
- •Current use of antibiotics or antibiotic treatment within 1 months before the first visit.
- •Consumption of probiotics within 1 month prior to the first visit.
- •Use of non-authorized medications (see Unauthorized Medications section).
- •Patients on a high fibre diet (>35 g/day for males, > 25 g/day for females), consuming high inulin containing foods (>5 g/day), and/or consuming dietary fibre supplements (as assessed by dietary assessment questionnaire) in the 4 weeks prior to the first visit.
- •Patients currently participating or having participated in a trial within the past month.
结局指标
主要结局
Irritable Bowel Syndrome (IBS) symptoms
时间窗: 1 week gluten or gluten+ATIs intervention compared to nocebo
Change in IBS symptoms (using Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) during dietary challenge compared to nocebo. The overall score ranges from 0-500 in total, with each of the 5 questions ranging from 0 to 100. A higher score indicates higher symptom severity and the total score is summed.
次要结局
- General gastrointestinal symptoms(1 week gluten or gluten+ATIs intervention compared to nocebo)
- Depression, anxiety and stress(1 week gluten or gluten+ATIs intervention compared to nocebo)
- Stool consistency(1 week gluten or gluten+ATIs intervention compared to nocebo)
- Diet assessment(Patients will be asked to take pictures of all meals during each of the 1 week diet challenges)
- Orocecal transit(1 week gluten or gluten+ATIs intervention compared to nocebo)
- Genetic predisposition for celiac disease(Patient HLA DQ2/8 status will be measured at baseline)
- Gluten levels in stool(Procedure will be explained at baseline)
- IBS symptom duration(Completed daily for 7 days after each diet challenge)
- Systemic immune reactivity(1 week gluten or gluten+ATIs intervention compared to nocebo)
- Gut microbiota profiles(1 week gluten or gluten+ATIs intervention compared to nocebo)
- Somatic symptoms(1 week gluten or gluten+ATIs intervention compared to nocebo)
- Anti-gliadin antibody (AGA) levels(Serum AGAs will be measured at baseline and after the challenge)
研究者
Premysl Bercik
MD, Associate Professor
McMaster University