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

NCT02906293 | Completed

• 1 other identifier: Pro00045465
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 1.Fasting intestinal rate will be consistently less than 14 events per minute, similar to previously documented bowel sound frequency.
2. 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. 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.

Conditions

Post-prandial Intestinal Rates

Outcome Measures

Primary Outcomes (3)

• Baseline fasting intestinal rate

  Prior to any oral intake, participants will record intestinal rate for 10 minutes

  10 minutes

• Pre-meal intestinal rate

  30 minutes prior to eating lunch participants will secure the device and record for 10 minutes

• Post-prandial intestinal rate

  Every 30 minutes for 5 hours after completion of meal

Study Arms (1)

Healthy Participants

Potential participants will self-refer.

Other: Abdominal acoustic measurement

Interventions

Abdominal acoustic measurement OTHER

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.

Healthy Participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai

Los Angeles, California, 90048, United States

Location

Related Publications (4)

• Baid H. A critical review of auscultating bowel sounds. Br J Nurs. 2009 Oct 8-21;18(18):1125-9. doi: 10.12968/bjon.2009.18.18.44555.

  PMID: 19966732 BACKGROUND

• 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.

  PMID: 24776861 BACKGROUND

• 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.

  PMID: 25091837 BACKGROUND

• 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.

  PMID: 26408329 BACKGROUND

Study Officials

• Christopher V. Almario, MD, MSHPM

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Health Services Research Scientist

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: September 20, 2016
• Study Start: March 1, 2017
• Primary Completion: July 17, 2017
• Study Completion: July 17, 2017
• Last Updated: February 20, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)