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

Post-prandial Intestinal Rates Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02906293
• Other study ID #: Pro00045465
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: July 17, 2017

Study information

• Verified date: February 2019
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 17, 2017
• Est. primary completion date: July 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-prandial Intestinal Rates

Intervention

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.

Locations

Country	Name	City	State
United States	Cedars-Sinai	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

Baid H. A critical review of auscultating bowel sounds. Br J Nurs. 2009 Oct 8-21;18(18):1125-9. Review. — View Citation

Felder S, Margel D, Murrell Z, Fleshner P. Usefulness of bowel sound auscultation: a prospective evaluation. J Surg Educ. 2014 Sep-Oct;71(5):768-73. doi: 10.1016/j.jsurg.2014.02.003. Epub 2014 Apr 24. — View Citation

Kaneshiro M, Kaiser W, Pourmorady J, Fleshner P, Russell M, Zaghiyan K, Lin A, Martinez B, Patel A, Nguyen A, Singh D, Zegarski V, Reid M, Dailey F, Xu J, Robbins K, Spiegel B. Postoperative Gastrointestinal Telemetry with an Acoustic Biosensor Predicts Ileus vs. Uneventful GI Recovery. J Gastrointest Surg. 2016 Jan;20(1):132-9; discussion 139. doi: 10.1007/s11605-015-2956-3. Epub 2015 Sep 25. — View Citation

Spiegel BM, Kaneshiro M, Russell MM, Lin A, Patel A, Tashjian VC, Zegarski V, Singh D, Cohen SE, Reid MW, Whitman CB, Talley J, Martinez BM, Kaiser W. Validation of an acoustic gastrointestinal surveillance biosensor for postoperative ileus. J Gastrointest Surg. 2014 Oct;18(10):1795-803. doi: 10.1007/s11605-014-2597-y. Epub 2014 Aug 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline fasting intestinal rate	Prior to any oral intake, participants will record intestinal rate for 10 minutes	10 minutes
Primary	Pre-meal intestinal rate		30 minutes prior to eating lunch participants will secure the device and record for 10 minutes
Primary	Post-prandial intestinal rate		Every 30 minutes for 5 hours after completion of meal