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N/A N=39

Biomarkers for Intestinal Permeability in Patients With Constipation

Intestinal Diseases · Irritable Bowel Syndrome · Constipation

Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Lactulose:C13 Mannitol Excretion Ratio 8-24hrs. — 0.01; 0.02 Ratio — p=0.87

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Permeability measurement (Diagnostic_test); Esophagogastroduodenoscopy (Procedure); Flexible sigmoidoscopy (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Mayo Clinic
Primary completion
Dec 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Lactulose:C13 Mannitol Excretion Ratio 8-24hrs.
0.01; 0.02 0.87
SECONDARY
Lactose:C13 Mannitol Excretion Ratio 0-2hours
0.007; 0.01
SECONDARY
Baseline Transmucosal Resistance (TMR) of Duodenal Mucosa
29.8; 28.16
SECONDARY
Cumulative FITC-Dextran (4kDa) Concentration Across Duodenal Mucosa
123.3; 156.8
SECONDARY
Rate of FITC-Dextran (4kDa) Flux Across Duodenal Mucosa
4980; 6528
SECONDARY
Baseline Transmucosal Resistance (TMR) of Colonic Mucosa
17.60; 19.06
SECONDARY
Cumulative FITC-Dextran (4kDa) Concentration Across Colonic Mucosa
132.2; 122.5
SECONDARY
Rate of FITC-Dextran (4kDa) Flux Across Colonic Mucosa
4931; 6069
SECONDARY
Cumulative E.Coli Bio- Particle K12 Concentration Across Duodenal Mucosa
1.48*10^4; 1.82*10^4
SECONDARY
Rate of E.Coli Bio- Particle K12 Flux Across Duodenal Mucosa
5.42*10^5; 5.70*10^5
SECONDARY
Cumulative E.Coli Bio- Particle K12 Concentration Across Colonic Mucosa
1.07*10^4; 2.09*10^4
SECONDARY
Rate of E.Coli Bio- Particle K12 Flux Across Colonic Mucosa
4.26*10^5; 7.67*10^5
SECONDARY
Duodenal Impedance
705.9; 729.5
SECONDARY
Mean Serum Endotoxin (Bacterial LPS) Levels
0.35; 0.36

Summary

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).

Eligibility Criteria

Inclusion criteria

  • 18 - 65 years old
  • IBS-C by Rome III criteria (for IBS-C participants)
  • No abdominal surgery (except appendectomy and cholecystectomy)

Exclusion criteria

  • History of Inflammatory Bowel Disease (IBD) , microscopic colitis or celiac disease
  • Use of tobacco products within the past 6 months
  • Use of NSAIDs or aspirin within the past week
  • Use of oral corticosteroids within the previous 6 weeks
  • Ingestion of artificial sweeteners such as Splenda (sucralose), Nutrasweet (aspartame), lactulose or mannitol 2 days before the study begins, 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 7 days before study begins
  • Any treatment specifically taken for IBS, including loperamide, cholestyramine, alosetron
  • Drugs with a known pharmacological activity at 5-HT4, 5-HT2b or 5-HT3 receptors (e.g, tegaserod, ondansetron, tropisetron, granisetron, dolasetron, mirtazapine);
  • All narcotics (e.g, codeine, morphine, and propoxyphene, either alone or in combination)
  • Anti-cholinergic agents (e.g, dicyclomine, hyoscyamine, propantheline).
  • Ultram
  • GI preparations
  • Anti-nausea agents (e.g, trimethobenzamide, promethazine, prochlorperazine, dimenhydrinate, hydroxyzine)
  • Osmotic laxative agents (e.g, lactulose, sorbitol or PEG solutions as Miralax and Glycolax)
  • Prokinetic agents (e.g, cisapride, metoclopramide, itopride, domperidone);
  • Antimuscarinics;
  • Peppermint oil;
  • Systemic antibiotics, rifaximin, metronidazole.
  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02246647). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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