Sucrose Breath Test to Determine Intestinal Permeability in IBS

NCT01674088 | Completed DMC

• 1 other identifier: SBT-01
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome; breath testing; carbon-13

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Metabolic Solutions Inc.: lead
• University of Florida: collaborator

Study Sites (1)

University of Florida Shands Hospital

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• David A Wagner, PhD

  Metabolic Solutions Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2012
• First Posted: August 28, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: February 10, 2014

Record last verified: 2014-02

Locations

US (1)