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Evaluation of Gastrointestinal Transit Pre and Pos Treatment With Non Selective Betablocker in a Population of Cirrhotics

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. Identifier: NCT02923336
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : January 31, 2019
Information provided by (Responsible Party):
ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Drug: non selective beta blocker Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Gastrointestinal Transite in Cirrhotic Patient Pre and Post Treatment With Non Selective Betablockers (Propanolol)
Study Start Date : May 2015
Actual Primary Completion Date : January 2019
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Smart pill
Single group, before and after, the same group is going to be its own control
Drug: non selective beta blocker
the patient is going to receive a device called "smart pill" before the beginning of treatment with propranolol, after the evaluation with the smart pill device, they are goning to take propranolol (dose of propranolol 80 mg per day) for 4 weeks,finally they will receive another smart pill to evaluate the second gastrointestinal transit time
Other Name: propranolol

Primary Outcome Measures :
  1. Gastrointestinal transit time before and after treatment with no selective betablocker [ Time Frame: 4 weeks of maximum non betablocker dose ]
    gastrointestinal time evaluated by a device called Smart pill

  2. Evaluatiuon of genes of tight junctions proteins before and after treatment with no selective betablocker [ Time Frame: 4 weeks of maximum non betablocker dose ]
    gene expression of tight junctions proteins in duodenal and gastric epithelium

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02923336

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Contact: Aldo Torre Delgadillo

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Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán Recruiting
Mexico, Cdmx, Mexico, 14080
Contact: Jonathan Aguirre Valadez, MD    55 27 55 80 49   
Sponsors and Collaborators
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Principal Investigator: Aldo Torre Delgadillo Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubiran

Publications of Results:
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Responsible Party: ALDO TORRE DELGADILLO, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Identifier: NCT02923336    
Other Study ID Numbers: GAS-1068-13/15-1
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Keywords provided by ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
liver cirrhosis
variceal bleeding
non selective beta blockers
Additional relevant MeSH terms:
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Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents