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AbStats: Assessing Post-Prandial Intestinal Event Rates in Healthy Individuals

2019年2月19日 更新者:Christopher Almario、Cedars-Sinai Medical Center

This study seeks to: Assess "normal" intestinal event rates for healthy subjects, to determine the effect of meal size on an individual's intestinal rate, and to determine whether there are differences between individuals in the fasting and post-prandial setting.

The investigators hypothesize the following:

  1. Fasting intestinal rate will be consistently less than 14 events per minute, similar to previously documented bowel sound frequency.
  2. There will a uniform increase in intestinal rate in the immediate post-prandial setting. There will be direct correlation between maximal and average post-prandial intestinal rates and meal size. Likewise, meal size will correlate with time to baseline fasting intestinal rate.
  3. Males and those with lower body mass index (BMI) will experience higher maximal and average post-prandial intestinal rates and shorter time to baseline fasting levels compared to females and those with higher BMI, respectively.

研究概览

详细说明

Participants will complete a baseline demographic and medical data sheet comprising of age, gender, race, ethnicity, height, weight, education, employment status, past medical history, and current prescription and over-the-counter medications. An AbStats device along with a log sheet will be provided to each subject, both of which will be returned upon completion of participation.

Upon waking, prior to oral intake, participants will place the AbStats disposable sensor on their abdomen and secure it using adhesive tape. The sensor is connected to a monitor which records the sounds collected by the sensors and interprets them to create and intestinal rate reading, measured as acoustic events per minute. The device will display a numerical intestinal rate reading, measured as acoustic events per minute. The device will display a numerical intestinal rate that participants will record on their personal log sheet. The purpose of this value is to assess the intestinal rate during fasting.

Participants will then eat a small standardized breakfast comprised of a thinkThin oatmeal single serve bowl, toasted English muffin with butter, and an 11oz iced coffee. No additions or substitutions are permitted in order to standardize the meal. The percent of food eaten will be recorded on the log sheet.

Lunch on Day 1 will be a "small meal" consisting of half of a turkey and Swiss Corner Bakery sandwich, cup of fruit, and 12oz can of diet soda. It will be eaten four to five hours after breakfast. No snacks are permitted between breakfast and lunch. Again, a pre-meal intestinal rate reading will be obtained 30 minutes prior to eating lunch; participants will secure the device onto the abdomen multiple times in order to gather post-prandial data. The intestinal rate will be recorded on the log sheet. The subject will record intestinal rate every 30 minutes for 5 hours after completion of the meal (e.g., lunch at 12 pm, then place sensors on abdomen for 10 minutes at 12:30 pm, 1:00 pm, 1:30 pm, 2:00 pm, 2:30 pm, 3:00 pm, 3:30 pm, 4: 00 pm, 4:30 pm, and 5:00 pm). Afterwards, participants can eat freely once these data points have been obtained. Dinner will be a meal of their choosing.

Day 2 of the study will be largely similar to Day 1: participants will measure fasting intestinal rate upon waking and will eat a standardized breakfast (see above). The main difference in Day 2 is that participants will eat a "large meal" for lunch consisting of a full turkey and Swiss Corner Bakery sandwich, cup of fruit, small bag of potato chips, small cookie, and a 12oz can of diet soda. The same pre- and post-lunch measurements notes above will be measured and recorded. By performing the above, investigators will assess preliminary intestinal rate measurements in the fasting state, after a small lunch (Day 1), and after a large lunch (Day 2).

研究类型

观察性的

注册 (实际的)

25

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

    • California
      • Los Angeles、California、美国、90048
        • Cedars-Sinai

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 至 65年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Healthy subjects

描述

Inclusion Criteria:

  • Healthy adults aged 18 to 65 years
  • Able to provide consent

Exclusion Criteria:

  • Age younger than 18 or older than 65 years
  • Unable to provide consent
  • Vegetarian or vegan
  • Pregnant
  • Prior intestinal surgery
  • Recent gastroenteritis, diverticulitis or stool infection within past 3 months
  • Diagnosis of irritable bowel syndrome
  • Diagnosis of inflammatory bowel disorder (Crohn's disease, ulcerative colitis, indeterminate colitis, microscopic colitis, gastritis or enterocolitis).
  • Diagnosis of a malabsorption disorder: Celiac disease, protein losing enteropathy, pancreatic insufficiency, etc.
  • Diagnosis of autoimmune disorder: diabetes mellitus, scleroderma, undifferentiated connective tissue disorder, etc.
  • Diagnosis of motility disorder: achalasia, esophageal spasm, outlet obstruction, gastroparesis, chronic constipation, etc.
  • History of acute pancreatitis within past 3 months
  • History of GI malignancy (stomach, small or large intestine, pancreatic, neuroendocrine tumor, etc.)
  • Current or recent treatment with chemotherapy within past 3 months
  • History of radiation treatment
  • Current or recent use (within past month) of medications that either promote or decrease motility: opioids, cholinergic agonists, opioid antagonists, anti-diarrheals, pro-kinetic medications (e.g., metoclopramide, domperidone, erythromycin), etc.
  • Antibiotic use within 3 months
  • Diabetes mellitus with HgA1C >6.0

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

  • 观测模型:仅案例
  • 时间观点:预期

队列和干预

团体/队列
干预/治疗
Healthy Participants
Potential participants will self-refer.
On Day 1 participants will record their intestinal rate at baseline fasting, pre-"small meal," and upon completion of the meal. On Day 2 participants will record their intestinal rate at baseline fasting, pre-"large meal," and upon completion of meal.

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
Baseline fasting intestinal rate
大体时间:10 minutes
Prior to any oral intake, participants will record intestinal rate for 10 minutes
10 minutes
Pre-meal intestinal rate
大体时间:30 minutes prior to eating lunch participants will secure the device and record for 10 minutes
30 minutes prior to eating lunch participants will secure the device and record for 10 minutes
Post-prandial intestinal rate
大体时间:Every 30 minutes for 5 hours after completion of meal
Every 30 minutes for 5 hours after completion of 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:Christopher V. Almario, MD, MSHPM、Cedars-Sinai Medical Center

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 (实际的)

2017年3月1日

初级完成 (实际的)

2017年7月17日

研究完成 (实际的)

2017年7月17日

研究注册日期

首次提交

2016年9月7日

首先提交符合 QC 标准的

2016年9月14日

首次发布 (估计)

2016年9月20日

研究记录更新

最后更新发布 (实际的)

2019年2月20日

上次提交的符合 QC 标准的更新

2019年2月19日

最后验证

2019年2月1日

更多信息

与本研究相关的术语

其他研究编号

  • Pro00045465

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

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.

Abdominal acoustic measurement的临床试验

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