N/A
N=39
Biomarkers for Intestinal Permeability in Patients With Constipation
Intestinal Diseases · Irritable Bowel Syndrome · Constipation
Bottom Line
View on ClinicalTrials.gov: NCT02246647 ↗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
| Outcome | Result | p-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
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.