Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhotic Patients

NCT05279586 | Unknown Early Phase 1

• 1 other identifier: encephalopathy prophylaxis
• Study Type: interventional
• Target: 316
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to compare the efficacy and safety of colistin versus lactulose for secondary prophylaxis of overt hepatic encephalopathy in patients with liver cirrhosis.

Conditions

Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• Development of overt hepatic encephalopathy

  Number of Participants with Development of overt hepatic encephalopathy encephalopathy according to West Haven criteria

  6 months

Secondary Outcomes (1)

• Health related quality of life

  6 months

Study Arms (2)

patients that will receive lactulose

ACTIVE COMPARATOR

Cirrhotic patients who were recovered from HE will be randomized into lactulose group receiving 30-60 ml of lactulose orally in 2 or 3 divided doses so that patient passed 2-3 semisoft stools per day

Drug: lactulose

patients that will receive colistin

ACTIVE COMPARATOR

colistin group receiving colistin sulfate 1.5 million I.U. tablet orally twice

Drug: colistin

Interventions

lactulose DRUG

all interventions are used in secondary prophylaxis in cirrhotic patients

Also known as: duphlac

patients that will receive lactulose

colistin DRUG

all interventions are used in secondary prophylaxis in cirrhotic patients

patients that will receive colistin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years.
• Patients with liver cirrhosis and previous history of recovery from hepatic encephalopathy.

You may not qualify if:

• History of taking lactulose in past 7 days
• Patients on secondary prophylaxis for spontaneous bacterial peritonitis
• Patients on psychoactive drugs, such as antidepressants or sedatives
• Previous transjugular intrahepatic portosystemic shunts or shunt surgery
• Significant comorbid illness such as heart, respiratory, or neurological disease such as Alzheimer's disease and Parkinson's disease
• Hepatocellular carcinoma or other neoplasias that could shorten life expectancy
• Recent infection or antibiotic use within last 6 weeks
• Recent gastrointestinal bleeding in the past 6 weeks
• Renal insufficiency, myasthenia gravis.
• Hypersensitivity to colistin sulfate.
• Pregnancy or lactation
• Alcohol intake

Sponsors & Collaborators

• Madonna Magdy Fahmy: lead

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

Lactulose; Colistin

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Polymyxins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Antimicrobial Cationic Peptides; Peptides; Amino Acids, Peptides, and Proteins; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins

Central Study Contacts

Madonna Magdy Fahmy, Master

CONTACT

01099794496; madona.magdy@med.tanta.edu.eg

Lobna Ahmed Abo Ali, professor

CONTACT

01147117052; lobna_fahmy@yahoo.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 15, 2022
• Study Start: March 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: March 1, 2023
• Last Updated: March 15, 2022

Record last verified: 2022-03