Sucrose Breath Test to Determine Intestinal Permeability in IBS
Irritable Bowel Syndrome (IBS) is a growing clinical diagnosis affecting 10-20% of the US population. While current diagnostic criteria aids in correctly diagnosing IBS, the cause of the disease still remains unclear. It has been hypothesized that patients with IBS have alterations in the intestinal lining leading to release of toxic substances into the blood, commonly referred to as leaky gut. Current methods used to study leaky gut are both expensive and invasive. The investigators will test a new breath test to measure leaky gut in both IBS patients and subjects without IBS symptoms.
Irritable Bowel Syndrome
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||The Use of a Novel 13C Sucrose Breath Test (13C SBT) to Determine Intestinal Permeability in Irritable Bowel Syndrome (IBS) Patients|
- Area under the breath 13CO2 concentration versus time curve (AUC) of sucrose [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]AUC curves will be generated after measurement of breath carbon-13 labeled carbon dioxide over 90 minutes of collection.
|Study Start Date:||October 2012|
|Study Completion Date:||January 2013|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Irritable Bowel Syndrome
Subjects meeting Rome III criteria will be included as the group Irritable Bowel Syndrome
Subjects not meeting Rome III criteria and meeting clinical definitions of general good health will be considered as Healthy Controls
The sucrose breath test involves taking by mouth 20 grams of common sucrose. This amount of sucrose is about 4 packets of sugar that you would use to sweeten a beverage. If subjects meet eligibility criteria, a single breath test will be conducted on all subjects. The breath test involves collecting breath by exhaling through a straw into a special test tube. A breath sample is collected before administration of sucrose. After the baseline breath sample, a sugar solution with the 20 grams of sucrose is administered by mouth. Three additional breath samples are collected at 30, 60 and 90 minutes. After 90 minutes, the protocol is finished. We will be analyzing breath carbon dioxide for different levels of heavy carbon atoms (carbon-13)with an instrument called an isotope ratio mass spectrometer. Our study plan is to compare the amount of carbon-13 in breath between IBS patients and subjects without the condition. Up to 20 subjects per group will be studied.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01674088
|United States, Florida|
|University of Florida Shands Hospital|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||David A Wagner, PhD||Metabolic Solutions Inc.|