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

Primary Purpose

Liver Cirrhosis

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
non selective beta blocker
Sponsored by
ALDO TORRE DELGADILLO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Cirrhosis focused on measuring liver cirrhosis, variceal bleeding, non selective beta blockers

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto Nacional de Ciencias Médicas Y Nutrición Salvador ZubiránRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Smart pill

Arm Description

Single group, before and after, the same group is going to be its own control

Outcomes

Primary Outcome Measures

Gastrointestinal transit time before and after treatment with no selective betablocker
gastrointestinal time evaluated by a device called Smart pill
Evaluatiuon of genes of tight junctions proteins before and after treatment with no selective betablocker
gene expression of tight junctions proteins in duodenal and gastric epithelium

Secondary Outcome Measures

Full Information

First Posted
October 2, 2016
Last Updated
January 29, 2019
Sponsor
ALDO TORRE DELGADILLO
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1. Study Identification

Unique Protocol Identification Number
NCT02923336
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
ALDO TORRE DELGADILLO

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
Keywords
liver cirrhosis, variceal bleeding, non selective beta blockers

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Smart pill
Arm Type
Other
Arm Description
Single group, before and after, the same group is going to be its own control
Intervention Type
Drug
Intervention Name(s)
non selective beta blocker
Other Intervention Name(s)
propranolol
Intervention Description
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
Primary Outcome Measure Information:
Title
Gastrointestinal transit time before and after treatment with no selective betablocker
Description
gastrointestinal time evaluated by a device called Smart pill
Time Frame
4 weeks of maximum non betablocker dose
Title
Evaluatiuon of genes of tight junctions proteins before and after treatment with no selective betablocker
Description
gene expression of tight junctions proteins in duodenal and gastric epithelium
Time Frame
4 weeks of maximum non betablocker dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aldo Torre Delgadillo
Email
detoal@yahoo.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aldo Torre Delgadillo
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubiran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán
City
Mexico
State/Province
Cdmx
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Aguirre Valadez, MD
Phone
55 27 55 80 49
Email
yanomani@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
23632359
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.
Results Reference
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Evaluation of Gastrointestinal Transit Pre and Pos Treatment With Non Selective Betablocker in a Population of Cirrhotics

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