Effect of Probiotics in Treatment of Minimal Hepatic Ence... | NCT01008293

Studies
Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life

NCT01008293

Sponsor

CD Pharma India Pvt. Ltd.

Status

Completed

Last Update Posted

Jun 4, 2013Estimated

Enrollment

120Actual

Phase

Phase 2Phase 3

Conditions

Chronic Liver Disease
Hepatic Encephalopathy

Interventions

VSL#3
Lactulose

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Jun 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Nov 4, 2009

First Submission Date that Met QC Criteria

Nov 4, 2009

First Posted Date

Nov 5, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2013

Last Update Posted Date

Jun 4, 2013Estimated

Name	Class
Indian Council of Medical Research	OTHER_GOV
All India Institute of Medical Sciences	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a randomized, open, parallel group, active comparator, single center trial. Objectives of the study are hereby given below:

To study the health related quality of life (HRQOL) in patients with chronic liver disease.
To assess the prevalence of minimal hepatic encephalopathy (MHE) in patients with chronic liver disease and assessment of HRQOL in patients with MHE.
To compare the effect of probiotics and lactulose in the treatment of MHE
To assess the effect of probiotics and lactulose on the HRQOL in patients with MHE.

Detailed Description

The study design would comprise of two parts

Part I: Cross sectional study: This part would comprise of the assessment of HRQOL in patients with CLD
1. All the consecutive patients diagnosed as CLD would be enrolled in the study. All these patients would be enrolled from the liver clinics of the department of gastroenterology and those admitted in the gastroenterology ward at AIIMS.
2. Alcohol would be considered to be the cause of CLD, if the patient regularly consumed ≥80g/d of alcohol for five years
3. The staging of cirrhosis would be done according to the Child Pugh classification: A, B and C
4. The causes of CLD would be divided into:- viral hepatitis, alcohol, viral hepatitis combining with alcohol and miscellaneous causes
Part II: Prospective randomized controlled trial: In this part the outcome of lactulose and probiotic therapy in the treatment of MHE and its effect on the HRQOL will be compared.
1. All the consecutive patients with CLD without overt encephalopathy would be screened for MHE.
2. All these patients would be enrolled from the liver clinics and the gastroenterology ward, AIIMS.
3. The diagnosis of MHE would be based on abnormal psychometric tests (NCT-A and NCT-B or FCT-A and FCT-B) and /or abnormal P300 auditory event related potentials.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VSL#3	Experimental		Drug: VSL#3
Lactulose	Active Comparator	30-60 ml of lactulose per day (2 months) to ensure 2-3 soft stools	Drug: Lactulose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VSL#3	Drug	VSL#3 (2 capsules bid.for 2 months, Each containing 112.5 billion viable lyophilized bacteria). Each capsule contains 4 strains of Lactobacillus (L. casei, L. plantarum, L. acidophilus, and L. delbrueckii subsp. bulgaricus), 3 strains of Bifidobacterium (B. longum, L. breve, and B. infantis), and 1 strain of Streptococcus salivarius subsp. thermophilus (designated hereafter as S. thermophilus)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To compare the effect of probiotics and lactulose based on normalization of the abnormal test parameters, Neuropsychometric tests, P3ERP, EEG, venous ammonia levels, Development of overt encephalopathy and other complications and HRQOL		2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All the patients with Chronic Liver Disease or Minimal Hepatic Encephalopathy (without overt hepatic encephalopathy) aged between 15 to 80 years of both the genders would be enrolled consecutively.

Exclusion Criteria:

Patients with overt hepatic encephalopathy
Active medical co-morbidities like CHD, chronic respiratory disease, chronic renal disease, malignancies, diabetes etc
Malignancy
History of taking lactulose or probiotics or antibiotics, in the past 6 weeks
Presence of other neurological or psychiatric disorder
Patients who underwent shunt surgery for portal hypertension
History of taking medicines likely to interfere with psychometric performance
History of GI hemorrhage or spontaneous bacterial peritonitis during the past 6 weeks
Presence of mature cataracts and diabetic retinopathy
Refused to participate in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Y K Joshi, Prof.	All India Institute of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Gastroenterology and H.N.U., All India Institute of Medical Sciences		New Delhi	National Capital Territory of Delhi	110029	India

Condition Browse Module

MeSH Terms

ID	Term
D006501	Hepatic Encephalopathy

Ancestor Terms

ID	Term
D017093	Liver Failure
D048550	Hepatic Insufficiency
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007792	Lactulose

Ancestor Terms

ID	Term
D004187	Disaccharides
D009844	Oligosaccharides
D011134	Polysaccharides
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided