NCT02484573

Brief Summary

This study seeks to investigate whether non-selective beta blocker treatment decreases intestinal permeability in cirrhotic patients by altering the expression of genes encoding intercellular junction proteins.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 29, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

4.7 years

First QC Date

June 16, 2015

Last Update Submit

January 29, 2019

Conditions

Liver Cirrhoses

Keywords

CirrhosisVariceal BleedingNon-selective beta blockerIntestinal PermeabilityGene expressionBacterial translocation

Outcome Measures

Primary Outcomes (1)

  • Intestinal permeability

    Evaluate and compare intestinal permeability using studies evaluating the absorption of three orally administered sugars (sucrose, mannitol and lactulose) in patients with cirrhosis before and after treatment with propranolol for 1 month.

    Baseline and after 4 weeks of propranolol treatment

Secondary Outcomes (3)

  • Expression of genes related to intestinal mucosal integrity

    Baseline and after 4 weeks of propranolol treatment

  • Presence of intercellular junction proteins by immunohistochemistry

    Baseline and after 4 weeks of propranolol treatment

  • Serum inflammatory markers

    Baseline and after 4 weeks of propranolol treatment

Study Arms (1)

Propanolol

EXPERIMENTAL

Patients will take the non-selective beta blocker propranolol for approximately 4 weeks starting immediately after endoscopy for esophageal variceal ligation. Patients will be initiated on a dose of 20mg by mouth every 12 hrs before titration to maximum tolerated dose. Patients will undergo testing before and after treatment for the variables listed in the outcomes section below.

Drug: Propanolol

Interventions

PropanololDRUG
Also known as: Inderalici
Propanolol

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 18 years
  • Diagnosis of cirrhosis of any etiology or severity as established by the treating physician (biopsy, biochemical, imaging)
  • High risk gastroesophageal varices, that is those with medium/large varices or any size varices with red wale signs
  • Scheduled appointment for endoscopic ligation as previously ordered by the treating physician
  • Signed informed consent
  • Ability to keep return appointments

You may not qualify if:

  • Beta blocker treatment within 1 month prior to study period
  • Antibiotic treatment during or within 1 month prior to study period
  • Prebiotic or probiotic treatment during or within 1 month before study period
  • Current immunosuppressive treatment
  • Patients with active infectious process
  • Patients with portal thrombosis
  • Patients with hepatocellular carcinoma
  • Patients with intestinal surgical shunts
  • Patients with chronic diarrhea or documented celiac disease
  • Patients with chronic renal failure (KDOQI: ≤ 3)
  • Patients with allergy or absolute contraindication for the use of nonselective beta blockers (asthma, significant heart block, systolic BP \<90 mm Hg, basal HR \<55, refractory ascites)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, 14000, Mexico

RECRUITING

MeSH Terms

Conditions

Fibrosis

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Aldo Torre, MD

    INCMNSZ

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aldo Torre Delgadillo, MD

CONTACT

525554870900detoal@yahoo.com

Jonathan Manuel Aguirre Valadez, MD

CONTACT

525554870900yanomani@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 16, 2015

First Posted

June 29, 2015

Study Start

May 1, 2015

Primary Completion

January 1, 2020

Study Completion

August 1, 2020

Last Updated

January 31, 2019

Record last verified: 2019-01

Locations

ME(1)