此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Brain-Gut Interactions in Overweight and Normal Weight Patients With Chronic Abdominal Pain

2019年11月19日 更新者:National Institute of Nursing Research (NINR)

About 15 to 20 percent of individuals living in the United States have chronic abdominal pain, often of unknown origin, which is often difficult to diagnose and treat. One possible cause of chronic abdominal pain is an inflammation of the intestines, but it is not known whether the two are related. Furthermore, although overweight people tend to be more likely to have increased inflammation, it is not known whether there is a connection between increased body weight and chronic abdominal pain. This study will examine the relationship between symptoms of chronic abdominal pain and intestinal inflammation by comparing the medical test results of normal weight and overweight patients who have a history of chronic abdominal pain.

This study will include 224 subjects, who must be men and women between the ages of 13 and 45. Half the subjects will be healthy participants, and half will have had chronic abdominal pain of unknown origin for longer than 6 months. Female participants must take a urine pregnancy test before starting the study, and will not be allowed to participate if the test is positive. During the study, patients will visit the NIH Clinical Center on two occasions for testing.

On the first visit, patients will provide a medical history, including information about current medications or natural remedies and tobacco and alcohol use, and will also fill out questionnaires to provide information about symptoms, current levels of gastrointestinal pain, and general quality of life. The study researchers will conduct a physical examination, measure patients height and weight, and draw blood for testing.

Patients will be asked to not eat or drink anything for 8 hours before the second visit, and will be asked to bring a bathing suit and a swim cap to the Clinical Center. On the day of the visit, patients will fill out questionnaires to provide information about symptoms, current levels of gastrointestinal pain, and general quality of life. Patients will also provide a blood sample for testing. Researchers will measure patients blood pressure and heart rate, height, weight, waist/hip circumference, and intra-abdominal measurement. Patients will also be asked to put on the bathing suit and swim cap to have their body fat measured using a machine called the BOD POD. To test the gastrointestinal system, patients will then be asked to drink a sugar-based test solution, and researchers will collect all voided urine for the next 5 to 6 hours. (Patients may drink water during this time.)

On either Day 1 or Day 2 of the study, patients will sip, swish and spit an additional sweet taste solution. Patients will sip, swish, and spit different concentrations of this sweet taste solution, for a total of 25 tastings of this solution. Subjects will then complete questionnaires about their sweetness preferences related to these 25 tastings.

研究概览

详细说明

The objective of this natural history study is to assess the specific gastrointestinal (GI) symptoms and pathophysiology of chronic abdominal pain of unknown origin at the molecular level. This research will test the hypothesis that chronic abdominal pain of unknown etiology has an inflammatory mechanism. Although increased body weight may be associated with increased inflammation, it is unclear that increased body weight is associated with chronic abdominal pain. Accordingly both overweight and normal weight subjects with and without chronic abdominal pain of unknown origin will be included in this study. The study design is a longitudinal natural history.

The purpose is to test the relationship between abdominal pain symptoms and intestinal inflammation in two groups (overweight and normal weight patients with chronic abdominal pain of unknown origin). After obtaining informed consent, an initial screening history and physical exam to ensure eligibility will be performed. The participants abdominal pain, psychological distress, quality of life, socio-demographic, and co-morbidities will be assessed via questionnaires. Anthropometry, vital signs, and fasting blood work will be drawn at both of the two visits to the Clinical Center of the National Institutes of Health for clinical screening labs and research purposes.

There are three measures of intestinal inflammation including fecal calprotectin, intestinal permeability, and serum cytokine IL-6 levels. A stool sample will be collected to measure fecal calprotectin. Intestinal permeability will be measured with the administration of a sugar based test solution which will be given orally to participants after an overnight fast on their second visit. Excreted urine sugar ratios, expressed per m2 of body surface area, will measure gastrointestinal permeability. Body mass and body fat analysis (plethysmography), intra-abdominal and liver ultrasound, and Fibroscan measures will also be collected on visit two. On either Day 1 or Day 2 of the study, patients will sip, swish and spit additional sweet taste solutions and complete questionnaires about their sweetness preferences related to these tastings.

研究类型

观察性的

注册 (实际的)

132

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Maryland
      • Bethesda、Maryland、美国、20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

13年 至 45年 (孩子、成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

  • INCLUSION CRITERIA:

To be included, patients must meet all of the following:

  • Have a history of abdominal pain for greater than 6 months
  • Males ages 13-45 years old or females ages 13-45 years old who have had their menses for at least 2 years
  • Provide written informed consent, prior to entering the study or undergoing any study procedures

EXCLUSION CRITERIA:

Patients with any of the following will be excluded:

  • Have a history of an organic GI disease (e.g., inflammatory bowel disease, celiac disease, biliary disorders, bowel resection) cardiac, pulmonary, neurologic, renal, endocrine, or gynecological pathology
  • Are currently taking medications for GI symptoms daily such as 5-HT3 antagonists/5-HT4 agonists, prokinetic drugs, laxatives (but not fiber supplements), anti-diarrheals or antispasmodics
  • Are currently taking other medications daily that would alter serotonin (e.g., serotonin specific reuptake inhibitors [SSRI]), catecholamines (e.g., tricycle antidepressants but not inhaled beta-agonist for mild-moderate asthma), cortisol (excluding inhaled corticosteroids)
  • Work during the late evening and night (as cortisol levels may be altered)
  • Severe co-morbid pain or psychiatric conditions (e.g., fibromyalgia, bipolar or psychotic disorder)
  • Take greater than 300 mg of caffeine containing beverages or food (e.g. chocolate) in the afternoon-evening or greater than 2 servings of alcohol containing beverages everyday (decaffeinated coffee is acceptable)
  • Are unable to give informed consent
  • Are unable to physically use the touch screen for the purpose of the study
  • Are visually impaired or currently institutionalized
  • Females who are pregnant or lactating
  • NINR employees, subordinates/relatives/ or co-workers
  • Any NIH employee who is a subordinate/relative/or co-worker of a study investigator

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
No intervention. Natural history study
大体时间:At enrollment
Compare abdominal pain and intestinal inflammation in normal weight and overweight individuals.
At enrollment

次要结果测量

结果测量
措施说明
大体时间
Natural History study.
大体时间:At enrollment
Characterize association between abdominal pain and inflammatory markers.
At enrollment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Wendy A Henderson, C.R.N.P.、National Institute of Nursing Research (NINR)

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年2月6日

研究完成

2019年11月13日

研究注册日期

首次提交

2009年1月16日

首先提交符合 QC 标准的

2009年1月16日

首次发布 (估计)

2009年1月19日

研究记录更新

最后更新发布 (实际的)

2019年11月20日

上次提交的符合 QC 标准的更新

2019年11月19日

最后验证

2019年11月13日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅