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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02484573 |
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Date of registration:
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16/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of Intestinal Permeability in Cirrhotic Patients Before and After Treatment With Non-selective Beta Blocker (Propranolol)
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Scientific title:
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Evaluation of Intestinal Permeability in Cirrhotic Patients Before and After Treatment With Non-selective Beta Blocker (Propranolol) |
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Date of first enrolment:
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May 2015 |
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Target sample size:
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39 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02484573 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Aldo Torre Delgadillo, M.D. M.Sc |
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Address:
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Telephone:
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54870900 |
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Email:
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detoal@yahoo.com |
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Affiliation:
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Name:
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Aldo Torre Delgadillo, MD |
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Address:
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Telephone:
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525554870900 |
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Email:
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detoal@yahoo.com |
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Affiliation:
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Name:
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Aldo Torre, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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INCMNSZ |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Liver Cirrhoses
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Intervention(s)
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Drug: Propanolol
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Primary Outcome(s)
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Intestinal permeability
[Time Frame: Baseline and after 4 weeks of propranolol treatment]
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Secondary Outcome(s)
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Expression of genes related to intestinal mucosal integrity
[Time Frame: Baseline and after 4 weeks of propranolol treatment]
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Presence of intercellular junction proteins by immunohistochemistry
[Time Frame: Baseline and after 4 weeks of propranolol treatment]
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Serum inflammatory markers
[Time Frame: Baseline and after 4 weeks of propranolol treatment]
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Secondary ID(s)
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GAS-1116-14/15-1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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