Main
|
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. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
12 December 2020 |
Main ID: |
NCT02923336 |
Date of registration:
|
02/10/2016 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Evaluation of Gastrointestinal Transit Pre and Pos Treatment With Non Selective Betablocker in a Population of Cirrhotics
|
Scientific title:
|
Evaluation of Gastrointestinal Transite in Cirrhotic Patient Pre and Post Treatment With Non Selective Betablockers (Propanolol) |
Date of first enrolment:
|
May 2015 |
Target sample size:
|
10 |
Recruitment status: |
Recruiting |
URL:
|
https://clinicaltrials.gov/show/NCT02923336 |
Study type:
|
Interventional |
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
|
Phase:
|
N/A
|
|
Countries of recruitment
|
Mexico
| | | | | | | |
Contacts
|
Name:
|
Jonathan Aguirre Valadez, MD |
Address:
|
|
Telephone:
|
55 27 55 80 49 |
Email:
|
yanomani@hotmail.com |
Affiliation:
|
|
|
Name:
|
Aldo Torre Delgadillo |
Address:
|
|
Telephone:
|
|
Email:
|
detoal@yahoo.mx |
Affiliation:
|
|
|
Name:
|
Aldo Torre Delgadillo |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Instituto Nacional de Ciencias Medicas y NutriciĆ³n Salvador Zubiran |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Cirrhosis of any ethiology
- Child Pugh A, B, C without beta-blocker treatment previously (min. 1 month without
treatment)
- Patients with previous variceal bleeding (with liver cirrhosis) * Patients with
ascites or bacterial spontaneous peritonitis
Exclusion Criteria:
- Variceal disease without cirrhosis
- Cirrhotics patients that use antibiotics, prebiotics and probiotics during the study
period and one month previously
- Patients under immunosuppressor treatment
- Patients with portal thrombosis
- Patients with Sd. Budd-Chiari or cava/suprahepatic thrombosis
- Patients with active infection process
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Liver Cirrhosis
|
Intervention(s)
|
Drug: non selective beta blocker
|
Primary Outcome(s)
|
Evaluatiuon of genes of tight junctions proteins before and after treatment with no selective betablocker
[Time Frame: 4 weeks of maximum non betablocker dose]
|
Gastrointestinal transit time before and after treatment with no selective betablocker
[Time Frame: 4 weeks of maximum non betablocker dose]
|
Secondary ID(s)
|
GAS-1068-13/15-1
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|