Clinical trial NCT02923336: Evaluation of Gastrointestinal Transit Pre and Pos Treatment With Non Selective Betablocker in a Population of Cirrhotics
Official title: Evaluation of Gastrointestinal Transite in Cirrhotic Patient Pre and Post Treatment With Non Selective Betablockers (Propanolol)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhosis
Keywords: liver cirrhosis
variceal bleeding
non selective beta blockers
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the influence of non betablockers in gastrointestinal motility (transit time) in patients with liver cirrhosis.

Detailed description: There is some evidence that cirrhotic patients have increased gastrointestinal transit time, this issue may favor bacterial owergrowth, and consequently bacterial translocation. Translocation of bacterias and its products are linked to vascular and hemodynamics alterations that produce descompensation on the disease. There is evidence , in animal models , that the use of beta blockers favors the gastrointestinal movement; decompensated cirrhotics had significantly longer small bowel transit time as compared with compensated cirrhotics, there have described that this alteration is related to de cirrhosis severity as assessed by Child Pugh score. The purpose of this study is to evaluate the gastrointestinal transit time before and after treatment of non selective betablockers, we are going to evaluate the gastrointestinal time before and after of 4 weeks of non selectivebetablocker treatment, in decompensated cirrhotics. The gastrointestinal time is going to be evaluate by the ingestion of a device known as "smart pill", that allow ambulatory monitoring of gastrointestinal transit.

Eligibility 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

Primary outcomes:
measure: Gastrointestinal transit time before and after treatment with no selective betablocker
timeFrame: 4 weeks of maximum non betablocker dose
measure: Evaluatiuon of genes of tight junctions proteins before and after treatment with no selective betablocker
timeFrame: 4 weeks of maximum non betablocker dose
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán
state: Cdmx
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubiran
name: Aldo Torre Delgadillo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chander Roland B, Garcia-Tsao G, Ciarleglio MM, Deng Y, Sheth A. Decompensated cirrhotics have slower intestinal transit times as compared with compensated cirrhotics and healthy controls. J Clin Gastroenterol. 2013 Nov-Dec;47(10):888-93. doi: 10.1097/MCG.0b013e31829006bb.