Sucrose Breath Test to Determine Intestinal Permeability in IBS

The Use of a Novel 13C Sucrose Breath Test (13C SBT) to Determine Intestinal Permeability in Irritable Bowel Syndrome (IBS) Patients

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida Shands Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinics of Shands Hospital, Gainesville, FL, residents within Gainesville, FL and students of the University of Florida.

Description

Inclusion Criteria:

• Male or females with clinical diagnosis of Irritable Bowel Syndrome by Rome III criteria (IBS Group) or healthy control.
• Must be 18 years old or greater.
• Women of child-bearing potential must have a negative pregnancy test.

Exclusion Criteria:

• Females who are lactating or pregnant.
• Subjects with allergy to sucrose.
• Subjects with other causes of abdominal pain or altered bowel habits such as IBD, celiac disease, pancreatitis or gastrointestinal bleeding.
• Subjects with a history of diabetes mellitus.
• Subjects with a recent febrile illness (5 days prior to study).
• Subjects that received an investigational drug or device within 30 days prior to study entry.
• Subjects that do not have the mental capacity to understand the protocol.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Irritable Bowel Syndrome; Subjects meeting Rome III criteria will be included as the group Irritable Bowel Syndrome
Healthy Controls; Subjects not meeting Rome III criteria and meeting clinical definitions of general good health will be considered as Healthy Controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the breath 13CO2 concentration versus time curve (AUC) of sucrose	AUC curves will be generated after measurement of breath carbon-13 labeled carbon dioxide over 90 minutes of collection.	90 minutes

Collaborators and Investigators

• Sponsor: Metabolic Solutions Inc.
• Collaborators: University of Florida

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): January 1, 2013

Study Registration Dates

• First Submitted: August 23, 2012
• First Submitted That Met QC Criteria: August 27, 2012
• First Posted (ESTIMATE): August 28, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): February 10, 2014
• Last Update Submitted That Met QC Criteria: February 6, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; breath testing; carbon-13
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: SBT-01