Secondary Prophylaxis of Hepatic Encephalopathy With a Probiotic Preparation

NCT01110447 | Completed Phase 2

• 1 other identifier: MHE2-VSL#3-Ver3_30032010
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the proposed project is to study the effects of a probiotic preparation (VSL#3®) for the prevention of recurrence of HE (Hepatic encephalopathy) in patients after the recovery of an episode of overt HE (secondary prophylaxis)

Conditions

Hepatic Encephalopathy

Keywords

Hepatic Encephalopathy, probiotics

Outcome Measures

Primary Outcomes (1)

• The primary end point will be development of overt HE or completion of a follow-up of 6 months after enrollment

  6 months after enrollment

Secondary Outcomes (1)

• Improvement in liver functions (Child and MELD score), psychometry (psychometric hepatic encephalopathy score), blood ammonia, blood cytokines level and survival time after medication

  6 months after enrollment

Study Arms (2)

VSL#3

EXPERIMENTAL

VSL#3® is made up of 4 strains of Lactobacilli (L. paracasei, L. plantarum, L. acidophilus and L. delbrueckii subsp. bulgaricus), 3 strains of Bifidobacteria (B. longum, B. infantis, B. breve) and 1 strain of Streptococcus thermophilus.

Drug: VSL#3

Placebo

PLACEBO COMPARATOR

Placebo sachets contain corn starch

Other: Placebo

Interventions

VSL#3 DRUG

VSL#3® is made up of 4 strains of Lactobacilli (L. paracasei, L. plantarum, L. acidophilus and L. delbrueckii subsp. bulgaricus), 3 strains of Bifidobacteria (B. longum, B. infantis, B. breve) and 1 strain of Streptococcus thermophilus. Dose would be 1 sachet per day (Each sachet containing 900 Billion CFU). The duration of treatment would be for 24 weeks

Also known as: Probiotic

VSL#3

Placebo OTHER

Placebo sachets contain corn starch. Dose: 1 sachet per day Duration of treatment: 24 weeks

Also known as: Dummy Preparation

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed as having cirrhosis of liver at the Inpatient/Outpatient Liver Clinic of Department of Hepatology, PGIMER, Chandigarh, will be candidates for enrollment.
• The diagnosis of cirrhosis of liver will be based on clinical, biochemical, and ultrasonographical or liver histological data.

You may not qualify if:

• Alcohol intake during the past 6 weeks
• Hepatocellular carcinoma
• Previous transjugular intrahepatic portosystemic shunt 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.
• Patients on psychoactive drugs, such as antidepressants or sedatives
• Those who restart alcohol consumption during follow-up will also be excluded.

Sponsors & Collaborators

• CD Pharma India Pvt. Ltd.: lead
• Post Graduate Institute of Medical Education and Research, Chandigarh: collaborator

Study Sites (1)

Dept. of Hepatology, PGIMER

Chandigarh, Chandigarh, 160012, India

Location

Related Publications (3)

• Dhiman RK, Grover GS, Premkumar M, Roy A, Taneja S, Duseja A, Arora S; MMPHCRF Investigators. Outcomes of Real-World Integrated HCV Microelimination for People Who Inject Drugs: An expansion of the Punjab Model. EClinicalMedicine. 2021 Oct 17;41:101148. doi: 10.1016/j.eclinm.2021.101148. eCollection 2021 Nov.

  PMID: 34712928 DERIVED

• Dhiman RK, Grover GS, Premkumar M, Taneja S, Duseja A, Arora S, Rathi S, Satsangi S, Roy A; MMPHCRF Investigators. Decentralized care with generic direct-acting antivirals in the management of chronic hepatitis C in a public health care setting. J Hepatol. 2019 Dec;71(6):1076-1085. doi: 10.1016/j.jhep.2019.07.006. Epub 2019 Jul 17.

  PMID: 31325468 DERIVED

• Dhiman RK, Rana B, Agrawal S, Garg A, Chopra M, Thumburu KK, Khattri A, Malhotra S, Duseja A, Chawla YK. Probiotic VSL#3 reduces liver disease severity and hospitalization in patients with cirrhosis: a randomized, controlled trial. Gastroenterology. 2014 Dec;147(6):1327-37.e3. doi: 10.1053/j.gastro.2014.08.031. Epub 2014 Aug 27.

  PMID: 25450083 DERIVED

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

Probiotics

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)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Radha K Dhiman, MD,DM,MNAMS

  Postgraduate Institute of Medical Education & Research (PGIMER)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: April 26, 2010
• Study Start: April 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 30, 2013

Record last verified: 2013-12

Locations

IN (1)