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

NCT ID: NCT02923336

Last Updated: 2019-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2021-05-31

Brief Summary

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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

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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.

Conditions

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Liver Cirrhosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Smart pill

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

Group Type OTHER

non selective beta blocker

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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propranolol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ALDO TORRE DELGADILLO

OTHER

Sponsor Role lead

Responsible Party

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ALDO TORRE DELGADILLO

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Aldo Torre Delgadillo

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubiran

Locations

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Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán

Mexico City, Mexico City, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Aldo Torre Delgadillo

Role: CONTACT

Facility Contacts

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Jonathan Aguirre Valadez, MD

Role: primary

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References

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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.

Reference Type RESULT
PMID: 23632359 (View on PubMed)

Other Identifiers

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GAS-1068-13/15-1

Identifier Type: -

Identifier Source: org_study_id

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