Performance of 13C Mannitol for in Vivo Measurement of Small Intestinal Permeability

• Status: Completed
• Trial end date: 2018-07-17
• Target enrollment: 0
• Participant gender: All

Summary

The investigators' overall objective with this study is to determine performance characteristics of small intestine permeability measurement using 13C mannitol and 12C (regular) mannitol.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Indomethacin; Lactulose; Mannitol

Criteria

Healthy Volunteers

Inclusion criteria:

• Age (yr) 18 to 65

• No abdominal surgery (except appendectomy and cholecystectomy, others may be considered)

Exclusion criteria:

• History of irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) (Crohn's disease or ulcerative colitis), microscopic colitis or celiac disease.

• Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)

• Use of nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin within seven days of first permeability test (as NSAIDs affect intestinal permeability) and second permeability test (except those administered for the study)

• Use of oral corticosteroids within the previous 6 weeks

• Ingestion of artificial sweeteners such as Splenda® (sucralose), NutraSweet® (aspartame), lactulose or mannitol within two (2) days of each permeability test and endoscopy procedure date, e.g., foods to be avoided are sugarless gums or mints and diet soda

• Ingestion of any prescription, over the counter, or herbal medications which can affect gastrointestinal transit within 7 days each permeability test and endoscopy procedure date. This includes drugs such as serotonin (5-HT) agents, narcotics, anticholinergics, anti-nausea medications, any medications for diarrhea or constipation.

• Antibiotics within 7 days each permeability test and endoscopy procedure date

• Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies.

• Score > 8 for anxiety or depression on Hospital Anxiety and Depression scale.

• Pregnancy