AbStats: Assessing Post-Prandial Intestinal Event Rates in Healthy Individuals
Completed
Conditions studied: Post-prandial Intestinal Rates
In brief
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.
Key facts
- Study ID
- NCT02906293
- Run by
- Cedars-Sinai Medical Center
- People needed
- 25
- Starts
- 2017-03-01
- Expected to finish
- 2017-07-17
- Last updated by the study team
- 2019-02-20
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
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
- 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
Where it is running
- Cedars-Sinai — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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