Mechanisms Underlying Development of Barrett's Esophagus in Patients With Gluten Related Disorders
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Ratio of non-acidic to acidic reflux events
研究概览
简要总结
In a small group of people gluten, a storage protein commonly in wheat and other grains, can cause gut inflammation and symptoms like diarrhea and abdominal pain. Gluten-related disorders include celiac disease (CD) and non-celiac gluten sensitivity (NCGS) and are treated by starting a gluten free diet (GFD). Patients with CD and NCGS also more commonly experience esophageal reflux and damage to the lining of the esophagus. A potential consequence of long-standing heartburn is Barrett's esophagus (BE), a major risk factor for cancer of the esophagus.
This study aims to investigate the mechanism that leads to reflux and BE in those with gluten related disorders, and to assess if a GFD is beneficial. We will study the upper gut function and reflux activity in patients with BE both with and without a GRD disorder. Testing will occur before and after a gluten free diet is instituted. The results will help inform health care providers and patients about the connection between gluten-related disorders, reflux, BE, and the role of GFD.
详细描述
Perhaps patient's with gluten related disorders develop Barrett's esophagus due to non-acid reflux precipitated by upper gastrointestinal motility changes that respond to a gluten free diet; whereas patients without gluten related disorders develop Barrett's due to the accepted mechanism of acid reflux.
The primary objectives are to explore if patients with gluten-related disorders (CD and GS) may have an altered mechanism of developing Barrett's esophagus typified by increased alkali reflux compared to those without gluten-related disorders; and to determine if this mechanism (altered motility and increased non-acid reflux) responds to a gluten free diet.
Specific objectives include assessing whether patients with GRD and Barrett's esophagus have altered esophageal reflux extent, frequency, and type (assessed by pH-impedance); altered symptom profiles; differential esophageal body and sphincter pressures (assessed by manometry); aberrant gastroduodenal motility (assessed by videofluoroscopy) in comparison to patients with BE and no GRD. Finally a gluten free diet will be instituted to assess whether a gluten-free diet alters esophageal reflux extent, frequency, and type or symptom profiles in those with BE with and without a GRD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Aged 18 years and over
- •Barrett's Esophagus diagnosis based on endoscopy and esophageal biopsies
- •Patients able to comply to the study procedures, according to the investigator's own judgment
排除标准
- •Patients who have been on a gluten free diet within the last six months
- •History of bariatric surgery, fundoplication, or gastrectomy (partial or complete)
- •Connective tissue disease
- •Concurrent organic GI pathology other than benign polyps, haemorrhoids, lipomas, H. pylori infection, diverticulosis, and melanosis coli
- •Chronic treatment with high dose opioids
- •Alcohol or drug abuse
- •Pregnant or breastfeeding women. Women enrolling in the study will be advised to avoid pregnancy during the course of the study by using adequate birth control such as abstinence, oral contraceptive pill, barrier contraceptives (i.e condom). If a subject becomes pregnant she will be withdrawn from the study.
- •Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be a risk or that could interfere with data collection
研究组 & 干预措施
Subjects with GRDs
An intervention of a change in diet, specifically a gluten free diet taught by a health care professional will be administered for one month's time.
干预措施: Gluten free diet (Other)
Subjects without GRDs
An intervention of a change in diet, specifically a gluten free diet taught by a health-care professional will be administered for one month's time.
干预措施: Gluten free diet (Other)
结局指标
主要结局
Ratio of non-acidic to acidic reflux events
时间窗: At study start and at one month after a gluten free diet
Proportion of non-acid to acid reflux events as determined by pH-impedance
次要结局
- Reflux disease questionnaire(At study start and one month after a gluten free diet)
- Leeds short form questionnaire(At study start and one month after a gluten free diet)
- Gastroesophageal reflux disease-health related quality of life instrument(At study start and one month after a gluten free diet)
- Esophageal motility(At study start)
- Upper gastrointestinal motility(At study start)