Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis

NCT01178372 | Unknown Phase 4 DMC

• 1 other identifier: PS002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatic encephalopathy (HE), a challenging complication of advanced liver disease, occurs in approximately 30-45% of patients with cirrhosis. The treatment of choice is non-absorbable disaccharides, such as lactulose and lactitol.Probiotics are effective in the treatment of minimal hepatic encephalopathy which precipitates hepatic encephalopathy. The investigators will assess the effects of lactulose and probiotics for the prevention of recurrence of HE (secondary prophylaxis) in patients after the recovery of an episode of overt hepatic encephalopathy.

Conditions

Hepatic Encephalopathy

Keywords

hepatic encephalopathy; lactulose; probiotics

Outcome Measures

Primary Outcomes (1)

• episode of overt hepatic encephalopathy

  6 months

Secondary Outcomes (1)

• side effects to therapy

  6 months

Study Arms (2)

lactulose

ACTIVE COMPARATOR

will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passed 2-3 semisoft stools per day

Drug: Lactulose

probiotics

ACTIVE COMPARATOR

Drug: Probiotics(VSL#3)

Interventions

Lactulose DRUG

will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passed 2-3 semisoft stools per day

lactulose

Probiotics(VSL#3) DRUG

will receive VSL#3 (110 billion CFU)three times a day

probiotics

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with cirrhosis and previous history of recovery from hepatic encephalopathy

You may not qualify if:

• history of taking lactulose in the past 6 weeks.
• alcohol intake during the past 6 weeks or during follow up
• patients on secondary prophylaxis for spontaneous bacterial peritonitis
• previous TIPS or shunt surgery
• significant comorbid illness such as heart, respiratory, or renal failure
• any neurologic diseases such as alzheimer's disease, parkinson's disease and nonhepatic metabolic encephalopathies.

Sponsors & Collaborators

• Govind Ballabh Pant Hospital: lead

Study Sites (1)

G B Pant Hospital

New Delhi, National Capital Territory of Delhi, 110002, India

RECRUITING

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

Lactulose

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

Study Officials

• Barjesh C Sharma, MD,DM

  G B Pant Hospital New Delhi 110002

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 9, 2010
• First Posted: August 10, 2010
• Study Start: September 1, 2008
• Study Completion: September 1, 2010
• Last Updated: August 10, 2010

Record last verified: 2009-09

Locations

IN (1)