Evaluation of Gastrointestinal Transit Pre and Pos Treatment With Non Selective Betablocker in a Population of Cirrhotics
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 2, 2016
CompletedFirst Posted
Study publicly available on registry
October 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedJanuary 31, 2019
January 1, 2019
3.7 years
October 2, 2016
January 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Gastrointestinal transit time before and after treatment with no selective betablocker
gastrointestinal time evaluated by a device called Smart pill
4 weeks of maximum non betablocker dose
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
4 weeks of maximum non betablocker dose
Study Arms (1)
Smart pill
OTHERSingle group, before and after, the same group is going to be its own control
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán
Mexico City, Mexico City, 14080, Mexico
Related Publications (1)
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.
PMID: 23632359RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aldo Torre Delgadillo
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubiran
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
October 2, 2016
First Posted
October 4, 2016
Study Start
May 1, 2015
Primary Completion
January 1, 2019
Study Completion
May 1, 2021
Last Updated
January 31, 2019
Record last verified: 2019-01