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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02906293
First Posted: September 20, 2016
Last Update Posted: August 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Christopher Almario, Cedars-Sinai Medical Center
  Purpose

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.

Condition Intervention
Post-prandial Intestinal Rates Other: Abdominal acoustic measurement

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: AbStats: Assessing Post-Prandial Intestinal Event Rates in Healthy Individuals

Further study details as provided by Christopher Almario, Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Baseline fasting intestinal rate [ Time Frame: 10 minutes ]
    Prior to any oral intake, participants will record intestinal rate for 10 minutes

  • Pre-meal intestinal rate [ Time Frame: 30 minutes prior to eating lunch participants will secure the device and record for 10 minutes ]
  • Post-prandial intestinal rate [ Time Frame: Every 30 minutes for 5 hours after completion of meal ]

Estimated Enrollment: 50
Actual Study Start Date: March 1, 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy Participants
Potential participants will self-refer.
Other: Abdominal acoustic measurement
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.

Detailed Description:

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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy subjects
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906293


Locations
United States, California
Cedars-Sinai
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Christopher V. Almario, MD, MSHPM Cedars-Sinai Medical Center