NCT02464124

Brief Summary

Hepatic encephalopathy (HE) is a reversible neuropsychiatric syndrome associated with chronic and acute liver dysfunction. It is characterized by cognitive and motor deficits of varying severity. Treatment options include lactulose administered orally or by nasogastric tube or enema, non-absorbable antibiotics, and protein-restricted diets. Nitazoxanide is an oral agent indicated for the treatment of infectious diarrhea caused by Crytpsporidiumparvum and Giardia lamblia. Basu and colleagues presented a pilot prospective study at the 2008 American Association for the Study of Liver Diseases meeting showing clinical improvement in HE among cirrhotic patients who received nitazoxanide and lactulose.

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
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2016

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

First Submitted

Initial submission to the registry

June 3, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 21, 2017

Status Verified

August 1, 2017

Enrollment Period

1.9 years

First QC Date

June 3, 2015

Last Update Submit

August 16, 2017

Conditions

Encephalopathy, Hepatic

Outcome Measures

Primary Outcomes (1)

  • Number of patients with total reversal of hepatic encephalopathy

    6 months

Study Arms (2)

lactulose plus nitazoxanide

EXPERIMENTAL

* Nitazoxanide dosing: 500 mg tablets twice daily * Lactulose dosing: 30-60 mL PO TID with goal 2-3 semisoft stools per day

Drug: NitazoxanideDrug: Lactulose

Lactulose alone

ACTIVE COMPARATOR

Lactulose dosing: 30-60 mL PO TID with goal 2-3 semisoft stools per day

Drug: Lactulose

Interventions

NitazoxanideDRUG

• Nitazoxanide dosing: 500 mg tablets twice daily

Also known as: Alenia, Nitclean, Parazoxanide
lactulose plus nitazoxanide
LactuloseDRUG

• Lactulose dosing: 30-60 mL PO TID with goal 2-3 semisoft stools per day

Also known as: Laxolac, Duphlac
Lactulose alonelactulose plus nitazoxanide

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70 years
  • Cirrhosis, defined by a combination of any of the following:
  • Laboratory findings
  • Endoscopic results
  • Ultrasound
  • Histology Overt hepatic encephalopathy

You may not qualify if:

  • Creatinine\>1.5 mg/dl
  • Alcohol use within prior 4 weeks
  • Non-hepatic metabolic encephalopathy
  • Hepatocellular carcinoma
  • Degenerative CNS disease
  • Any significant psychiatric illness or other medical comorbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta university - faculty of medicine

Tanta, Elgharbia, Egypt

RECRUITING

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

nitazoxanideLactulose

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Asem Elfert, Prof

    hepatology dept-Tanta

    PRINCIPAL INVESTIGATOR

  • Sherief Abd-Elsalam, lecturer

    hepatology dept-Tanta

    STUDY DIRECTOR

  • Samah Soliman, lecturer

    hepatology dept-Tanta

    STUDY CHAIR

  • Walaa elkhalawany, lecturer

    hepatology dept-Tanta

    STUDY CHAIR

  • Rehab elsheshtawi, lecturer

    hepatology dept-Tanta

    STUDY CHAIR

  • Mennat-Allah Elsawaf, lecturer

    hepatology dept-Tanta

    STUDY CHAIR

Central Study Contacts

Sherief Abd-elsalam, lecturer

CONTACT

00201095159522Sheriefabdelsalam@yahoo.com

Sherief Abd-elsalam, lecturer

CONTACT

00201095159522sherif_tropical@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
sponsor investigator

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 8, 2015

Study Start

January 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

August 21, 2017

Record last verified: 2017-08

Locations

EG(1)