Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
NCT Number: NCT02246647
Our overall objective with this study is firstly to provide a comprehensive assessment of intestinal permeability, mucosal barrier function using existing biomarkers and secondly to explore novel biomarkers for measuring intestinal permeability in patients with constipation predominant Irritable Bowel Syndrome (IBS-C).
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Notify Me18 year–65 year
Female
Observational
Rochester, Minnesota, 55905, United States
In order to determine the differences in permeability in IBS-C in comparison with healthy volunteers, the following will be determined: differences in in vivo small intestinal and colonic permeability, differences in small intestinal and colonic mucosal barrier function, differences in effects of fecal supernatants on barrier function of T84 monolayers, and differences in novel biomarkers for intestinal permeability
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Saccharide excretion was compared between IBS-C and healthy volunteers
Other names: 12C Mannitol, 13C Mannitol, Lactulose
Duodenal biopsies were collected from IBS-C and healthy volunteers
Colonic biopsies were collected from IBS-C and healthy volunteers
Time frame: 8-24 hr post test-dose administration
In vivo measurement of intestinal permeability using 13C mannitol & lactulose was used. High performance liquid chromatography-tandem mass spectrometry was used to measure concentrations calculated using the overall urine volume excreted in each interval. Concentrations of 13C adjusted for the % of 13C in 12C mannitol (4.98% of 12C mannitol excreted was subtracted from 13C mannitol values; determined by analyzing replicate samples of control urine). All lactulose or 13C mannitol concentrations 8-24hr post-ingestion were used to determine colonic permeability. Lactulose to 13C mannitol excretion ratios, as a measure of dose of saccharide administered, were calculated.
Time frame: 0-2 hr post-test dose administration
Time frame: Baseline
Time frame: 3 hours post FITC-Dextran (4kDa) administration
This is not a pharmacokinetic or pharmacodynamic measure. Hence only one time assessment is made 3 hours after FITC-Dextran (4kDa) administration.
Time frame: Over 3 hours post FITC-Dextran (4kDa) administration
This is not a pharmacokinetic or pharmacodynamic measure. Hence only one time assessment is made 3 hours after FITC-Dextran (4kDa) administration.
Time frame: Baseline
Time frame: 3 hours post FITC-Dextran (4kDa) administration
Time frame: Over 3 hours post FITC-Dextran (4kDa) administration
Time frame: 3 hours post E.coli Bio- Particle administration
Time frame: Over 3 hours post E.coli Bio- Particle administration
Time frame: 3 hours post E.coli Bio- Particle administration
Time frame: Over 3 hours post E.coli Bio- Particle administration
Time frame: Baseline
Time frame: Fasting, one time measurement after 8 hours
Mayo Clinic
Other
Biomarkers for Intestinal Permeability in Patients With Functional Lower Gastrointestinal Disorders Associated With Constipation.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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