Evaluation of Intestinal Permeability in Cirrhotic Patients Before and After Treatment With Non-selective Beta Blocker (Propranolol)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02484573|
Recruitment Status : Recruiting
First Posted : June 29, 2015
Last Update Posted : January 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Liver Cirrhoses||Drug: Propanolol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Intestinal Permeability in Cirrhotic Patients Before and After Treatment With Non-selective Beta Blocker (Propranolol)|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||August 2020|
Patients will take the non-selective beta blocker propranolol for approximately 4 weeks starting immediately after endoscopy for esophageal variceal ligation. Patients will be initiated on a dose of 20mg by mouth every 12 hrs before titration to maximum tolerated dose. Patients will undergo testing before and after treatment for the variables listed in the outcomes section below.
Other Name: Inderalici
- Intestinal permeability [ Time Frame: Baseline and after 4 weeks of propranolol treatment ]Evaluate and compare intestinal permeability using studies evaluating the absorption of three orally administered sugars (sucrose, mannitol and lactulose) in patients with cirrhosis before and after treatment with propranolol for 1 month.
- Expression of genes related to intestinal mucosal integrity [ Time Frame: Baseline and after 4 weeks of propranolol treatment ]Evaluate and compare the expression of mRNA of the genes for zona occludens 1 (ZO1), occludin, claudin-1 and 2 in gastric and duodenal mucosal tissue of patients with cirrhosis, before and after treatment with propranolol for 1 month.
- Presence of intercellular junction proteins by immunohistochemistry [ Time Frame: Baseline and after 4 weeks of propranolol treatment ]Evaluate and compare the presence of intercellular junction proteins by immunohistochemistry in gastric and duodenal mucosa of patients with cirrhosis before and after treatment with propranolol for 1 month.
- Serum inflammatory markers [ Time Frame: Baseline and after 4 weeks of propranolol treatment ]Compare serum proinflammatory cytokines and lipopolysaccharide levels in patients with cirrhosis before and after treatment with propranolol for 1 month.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02484573
|Contact: Aldo Torre Delgadillo, MDfirstname.lastname@example.org|
|Contact: Jonathan Manuel Aguirre Valadez, MDemail@example.com|
|Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran||Recruiting|
|Mexico City, Mexico, 14000|
|Contact: Aldo Torre Delgadillo, M.D. M.Sc 54870900 ext 2711 firstname.lastname@example.org|
|Principal Investigator: Aldo Torre-Delgadillo, MD|
|Principal Investigator:||Aldo Torre, MD||INCMNSZ|