Sucrose Breath Test to Determine Intestinal Permeability in IBS

This study has been completed.
Sponsor:
Collaborator:
University of Florida
Information provided by (Responsible Party):
Metabolic Solutions Inc.
ClinicalTrials.gov Identifier:
NCT01674088
First received: August 23, 2012
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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.


Condition
Irritable Bowel Syndrome

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Metabolic Solutions Inc.:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: October 2012
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01674088

Locations
United States, Florida
University of Florida Shands Hospital
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
Metabolic Solutions Inc.
University of Florida
Investigators
Principal Investigator: David A Wagner, PhD Metabolic Solutions Inc.
  More Information

No publications provided

Responsible Party: Metabolic Solutions Inc.
ClinicalTrials.gov Identifier: NCT01674088     History of Changes
Other Study ID Numbers: SBT-01
Study First Received: August 23, 2012
Last Updated: February 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Metabolic Solutions Inc.:
Irritable Bowel Syndrome
breath testing
carbon-13

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014