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

Evaluation of Gastrointestinal Transite in Cirrhotic Patient Pre and Post Treatment With Non Selective Betablockers (Propanolol)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02923336
Enrollment
10
Registered
2016-10-04
Start date
2015-05-31
Completion date
2021-05-31
Last updated
2019-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis

Keywords

liver cirrhosis, variceal bleeding, non selective beta blockers

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.

Interventions

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

Sponsors

ALDO TORRE DELGADILLO
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Gastrointestinal transit time before and after treatment with no selective betablocker4 weeks of maximum non betablocker dosegastrointestinal time evaluated by a device called Smart pill
Evaluatiuon of genes of tight junctions proteins before and after treatment with no selective betablocker4 weeks of maximum non betablocker dosegene expression of tight junctions proteins in duodenal and gastric epithelium

Countries

Mexico

Contacts

Primary ContactAldo Torre Delgadillo
detoal@yahoo.mx

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026