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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-01

Study Completion Date

2017-07-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Gastric Motor Function Measurement in Dyspepsia and Normal Subjects

NCT00296582

Dyspepsia

COMPLETED NA

Gastric Emptying: in Vivo Studies in Healthy Volunteers

NCT02994472

Gastric Disease

UNKNOWN NA

Effects of Exercise on Functional Dyspepsia Based on Rome IV

NCT04540549

Functional Dyspepsia

UNKNOWN NA

Use of MRI for Assessing Stomach Relaxation in Response to a Meal

NCT00275743

Dyspepsia Healthy Volunteers

COMPLETED PHASE1

High Resolution Gastric Mapping and Gastroduodenal Manometry

NCT06941545

Dyspepsia

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-prandial Intestinal Rates

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy Participants

Potential participants will self-refer.

Abdominal acoustic measurement

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes