Liver CirrhosisNCT02923336
Evaluation of Gastrointestinal Transit Pre and Pos Treatment With Non Selective Betablocker in a Population of Cirrhotics
A study testing non selective beta blocker in people with Liver Cirrhosis, run by ALDO TORRE DELGADILLO at 1 site in Mexico.
Trial summary
The purpose of this study is to evaluate the influence of non betablockers in gastrointestinal motility (transit time) in patients with liver cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- non selective beta blocker
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteMexico
- Study dates
- May 2015to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Aldo Torre Delgadillo contact
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán
Mexico City, Mexico City, 14080
Jonathan Aguirre Valadez, MD, 55 27 55 80 49, yanomani@hotmail.com
About this study
Official title: Evaluation of Gastrointestinal Transite in Cirrhotic Patient Pre and Post Treatment With Non Selective Betablockers (Propanolol)
The purpose of this study is to evaluate the influence of non betablockers in gastrointestinal motility (transit time) in patients with liver cirrhosis.
Read the 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.
- Conditions
- Liver Cirrhosis
- Being tested
- non selective beta blocker
- Keywords
- liver cirrhosis, variceal bleeding, non selective beta blockers
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non selective beta blockerDrug
Also called propranolol
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
| Study group | Role | What they receive |
|---|---|---|
| Smart pill | Other | Single group, before and after, the same group is going to be its own control Receives: Drug: non selective beta blocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal transit time before and after treatment with no selective betablocker
gastrointestinal time evaluated by a device called Smart pill
Measured: 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
Measured: 4 weeks of maximum non betablocker dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startMay 2015
- Primary completionJan 2019
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ALDO TORRE DELGADILLO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Aldo Torre Delgadillo, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923336
- Sponsor's protocol ID
- GAS-1068-13/15-1
- Status last verified
- Jan 2019
- First submitted
- 2 Oct 2016
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23632359
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gastrointestinal Transite in Cirrhotic Patient Pre and Post Treatment With Non Selective Betablockers (Propanolol)
- ClinicalTrials.gov ID
- NCT02923336
- Acronym / sponsor ID
- GAS-1068-13/15-1
- Conditions
- Liver Cirrhosis
- Keywords
- liver cirrhosis, variceal bleeding, non selective beta blockers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- ALDO TORRE DELGADILLOUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jan 2019 (actual)
- Study completion
- May 2021 (estimated)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smart pill | Other | Drug: non selective beta blockerSingle group, before and after, the same group is going to be its own control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non selective beta blockerAlso: propranololthe 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 | Drug | Smart pill |
Primary outcome
Gastrointestinal transit time before and after treatment with no selective betablocker
Time frame: 4 weeks of maximum non betablocker dose
gastrointestinal time evaluated by a device called Smart pill
Evaluatiuon of genes of tight junctions proteins before and after treatment with no selective betablocker
Time frame: 4 weeks of maximum non betablocker dose
gene expression of tight junctions proteins in duodenal and gastric epithelium
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Results publication: PubMed 23632359Chander 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aldo Torre Delgadillo contact
Aldo Torre Delgadillo principal investigator
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubiran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non selective beta blocker in people with Liver Cirrhosis, run by ALDO TORRE DELGADILLO at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aldo Torre Delgadillo (detoal@yahoo.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal transit time before and after treatment with no selective betablocker (time frame: 4 weeks of maximum non betablocker dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02923336, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.