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。

Assessment of Gastric Emptying Speed in Patients Who Experience Diarrhea Following a Trigger Meal

2012年4月18日 更新者:Mary E. Money, M.D.、Money, Mary E., M.D.

Pilot Study: Assessment of Gastric and Intestinal Motility Following a Trigger Meal in Patients With Post Prandial Diarrhea

The rapid diarrhea that patients experience who have diarrhea occurring after eating specific foods may be causing a "physiologic gastric dumping syndrome". This means that rather than the food being kept in the stomach for normal digestion, it rapidly goes into the small intestine and diarrhea occurs. This study is designed to measure how fast the food empties from the stomach when a person with this problem consumes a "regular diet", compared to a meal with a "triggering substance". Each participant will swallow a radio frequency capsule that with the different meals that will show how fast the food is traveling through the intestines in the different situations.

研究概览

详细说明

Since some patients have found that pancreatic enzymes seem to ameliorate this diarrhea from occurring,willing participants will be asked to duplicate the "triggering meal" 2 more times. Once taking a pancreatic enzyme (active drug) with the meal and a second time taking an identical placebo. Neither the participant nor the study investigator will know which capsule is the active drug in this phase of the study. Willing participants will receive a small stipend each time they swallow the radio frequency capsule. This capsule is large, approximately twice the size of a vitamin pill so individuals must have no difficulties with swallow to participate nor any history of bowel obstruction or major surgery to the abdominal which might have caused adhesions.

研究类型

介入性

阶段

  • 不适用

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

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. The patient must have been diagnosed as having post prandial diarrhea for at least 5 years by his/her primary care physician or gastroenterologist and is believed to have no other medical condition that would cause this medical problem. Each person must be over 18 years old and have negative testing for Celiac Disease, a normal colonoscopy within 5 years of enrollment, and a normal Hgb and sedimentation rate within 6 months of enrollment in the trial.
  2. The patient has provided documented written informed consent/authorization prior to initiation of any study-related procedure.
  3. In addition, each patient must report experiencing the onset of urgent defecation within 1 hours of eating a specific trigger which is reproducible at least 90% of the time when consume.
  4. The patient must be willing to comply with all of the study protocol.

Exclusion Criteria:

  1. The patient has had any rectal bleeding or bloody stools within the last 2 years not completely evaluated by a physician. If rectal bleeding has occurred, and the patient wants to be considered for the study, the diagnostic workup must have clearly identified the etiology for the bleeding and excluded the medical conditions listed under 3 below. The patient must be willing to allow the Study team to obtain these records for verification of the diagnosis.
  2. The patient has nocturnal bowel movements.
  3. The patient has been diagnosed with or has a family history of any of the following: ulcerative colitis, Crohn's Disease, celiac disease, sprue, other inflammatory bowel disease or has a positive test for celiac disease on screening lab and has not had a full investigation performed to exclude celiac disease.
  4. The patient has had unexplained anorexia or weight loss of more than 10% of body weight within 12 months of onset of study.
  5. Prior GI surgery except of uncomplicated appendectomy and laparoscopic cholecystectomy or history of bowel obstruction or symptoms suggestive of such within the past 2 years.
  6. The patient reports daily use of laxatives or stool softeners; use of fiber supplementation is permitted.
  7. The patient is currently using pancrealipase. Previous use of pancrealipase in the past is allowed, but patients must be off either of the medication for at least 1 week or until the patient's symptoms of post prandial diarrhea returns before participating in the study.
  8. Use of implanted or ambulatory electromechanical medical devices such as pacemakers, insulin pumps, and infusion pumps.
  9. History of gastroparesis or chronic use of reglan.
  10. Dysphagia to solid food and pills.
  11. Previous gastro-esophageal surgery including vagotomy, fundoplication, gastric bypass or ulcer surgery.
  12. Tobacco use within eight hours prior to capsule ingestion and during the 8 hour monitoring time.
  13. Alcohol use within 24 hours prior to capsule ingestion and throughout the entire monitoring period (up to 72 hours).
  14. BMI > 35
  15. Female of childbearing age who is not practicing birth control and/or is pregnant or lactating. (Confirm with urine pregnancy test).

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

  • 主要用途:诊断
  • 分配:非随机化
  • 介入模型:交叉作业
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:non-trigger meal
Measurement of intestinal transport eating a "non-trigger meal".
Measurement of a baseline, non-trigger meal intestinal transit by using the SmartPill capsule.
Measurement of intestinal transit of a "trigger meal" baseline by using the SmartPill capsule
SmartPill capsule
有源比较器:"trigger meal baseline"
Measurement of intestinal transport after eating a "trigger meal".
Measurement of a baseline, non-trigger meal intestinal transit by using the SmartPill capsule.
Measurement of intestinal transit of a "trigger meal" baseline by using the SmartPill capsule
SmartPill capsule
安慰剂比较:"trigger meal" with placebo
Measurement of intestinal transport with blinded placebo
Measurement of a baseline, non-trigger meal intestinal transit by using the SmartPill capsule.
Measurement of intestinal transit of a "trigger meal" baseline by using the SmartPill capsule
SmartPill capsule
ZenPep 20000 units of lipase will be provided for the participant to take with a trigger meal or an identical placebo. This will only be given to those participants willing to consume 2 more identical "trigger meals" and will not be given for the initial baseline "non-trigger" and baseline "trigger meal". In both of these arms, patients will also be swallowing the SmartPill Capsule.
有源比较器:"trigger meal" with enzymes (blinded)
Measurement of intestinal transport with blinded active enzyme capsule
Measurement of a baseline, non-trigger meal intestinal transit by using the SmartPill capsule.
Measurement of intestinal transit of a "trigger meal" baseline by using the SmartPill capsule
SmartPill capsule
ZenPep 20000 units of lipase will be provided for the participant to take with a trigger meal or an identical placebo. This will only be given to those participants willing to consume 2 more identical "trigger meals" and will not be given for the initial baseline "non-trigger" and baseline "trigger meal". In both of these arms, patients will also be swallowing the SmartPill Capsule.

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
Duration of intestinal speed of a "trigger meal" compared to a non-trigger meal baseline. Optional study comparing intestinal speed of trigger meal using Pancrelipase compared to placebo.
大体时间:72 hour measurement per meal
Data from the SmartPill radiofrequency capsule that is swallowed at the beginning of the different meals will be recorded and compared.
72 hour measurement per meal

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:Mary E Money, M.D.、Washington County Hospital

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。

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

2010年4月1日

初级完成 (实际的)

2011年1月1日

研究完成 (实际的)

2011年1月1日

研究注册日期

首次提交

2010年4月25日

首先提交符合 QC 标准的

2010年4月29日

首次发布 (估计)

2010年4月30日

研究记录更新

最后更新发布 (估计)

2012年4月20日

上次提交的符合 QC 标准的更新

2012年4月18日

最后验证

2012年4月1日

更多信息

与本研究相关的术语

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.

肠易激综合症的临床试验

  • Sanford Health
    National Ataxia Foundation; Beyond Batten Disease Foundation; Pitt Hopkins Research Foundation; Cornelia... 和其他合作者
    招聘中
    线粒体疾病 | 色素性视网膜炎 | 重症肌无力 | 嗜酸性胃肠炎 | 多系统萎缩 | 平滑肌肉瘤 | 脑白质营养不良 | 肛瘘 | 脊髓小脑性共济失调3型 | 弗里德赖希共济失调 | 肯尼迪病 | 莱姆病 | 噬血细胞性淋巴组织细胞增生症 | 脊髓小脑性共济失调1型 | 脊髓小脑性共济失调2型 | 脊髓小脑共济失调6型 | 威廉姆斯综合症 | 先天性巨结肠症 | 糖原贮积病 | 川崎病 | 短肠综合症 | 低磷血症 | Leber先天性黑蒙 | 口臭 | 贲门失弛缓症 | 多发性内分泌肿瘤 | 利综合症 | 艾迪生病 | 多发性内分泌肿瘤 2 型 | 硬皮病 | 多发性内分泌肿瘤 1 型 | 多发性内分泌肿瘤 2A 型 | 多发性内分泌肿瘤 2B 型 | 非典型溶血性尿毒症综合征 | 胆道闭锁 | 痉挛性共济失调 | WAGR综合症 | 无虹膜 | 短暂性失忆症 | 马尾综合症 | Refsum 疾病 | 复发性呼吸... 及其他条件
    美国, 澳大利亚

SmartPill capsule的临床试验

3
订阅