Liver Cirrhoses Clinical Trial
Official title:
Evaluation of Intestinal Permeability in Cirrhotic Patients Before and After Treatment With Non-selective Beta Blocker (Propranolol)
NCT number | NCT02484573 |
Other study ID # | GAS-1116-14/15-1 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2015 |
Est. completion date | August 2020 |
This study seeks to investigate whether non-selective beta blocker treatment decreases intestinal permeability in cirrhotic patients by altering the expression of genes encoding intercellular junction proteins.
Status | Recruiting |
Enrollment | 39 |
Est. completion date | August 2020 |
Est. primary completion date | January 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - > 18 years - Diagnosis of cirrhosis of any etiology or severity as established by the treating physician (biopsy, biochemical, imaging) - High risk gastroesophageal varices, that is those with medium/large varices or any size varices with red wale signs - Scheduled appointment for endoscopic ligation as previously ordered by the treating physician - Signed informed consent - Ability to keep return appointments Exclusion Criteria: - Beta blocker treatment within 1 month prior to study period - Antibiotic treatment during or within 1 month prior to study period - Prebiotic or probiotic treatment during or within 1 month before study period - Current immunosuppressive treatment - Patients with active infectious process - Patients with portal thrombosis - Patients with hepatocellular carcinoma - Patients with intestinal surgical shunts - Patients with chronic diarrhea or documented celiac disease - Patients with chronic renal failure (KDOQI: = 3) - Patients with allergy or absolute contraindication for the use of nonselective beta blockers (asthma, significant heart block, systolic BP <90 mm Hg, basal HR <55, refractory ascites) |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Mexico City |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intestinal permeability | 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. | Baseline and after 4 weeks of propranolol treatment | |
Secondary | Expression of genes related to intestinal mucosal integrity | 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. | Baseline and after 4 weeks of propranolol treatment | |
Secondary | Presence of intercellular junction proteins by immunohistochemistry | 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. | Baseline and after 4 weeks of propranolol treatment | |
Secondary | Serum inflammatory markers | Compare serum proinflammatory cytokines and lipopolysaccharide levels in patients with cirrhosis before and after treatment with propranolol for 1 month. | Baseline and after 4 weeks of propranolol treatment |
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