Pentoxyphilline Versus Fecal Microbiota Therapy in Severe Alcoholic Hepatitis

NCT02458079 | Completed

• 1 other identifier: ILBS-AH-02
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment for severe alcoholic hepatitis patients not eligible for steroid therapy is a dilemma. Pentoxyfilline has been shown to have no improvement in outcomes as per current studies and liver transplantation is with great risk of recidivism in this difficult to treat cohort of patients. Dysbiosis forms the central role in severe alcoholic hepatitis patients and modulation of gut microbiota by way of healthy donor fecal transplantation could prove to be a novel way to treating these patients who are ineligible for standard therapy. This study utilizes correction of dysbiosis in severe alcoholic hepatitis and surveys outcomes with the same with respect to survival and liver disease severity scores.

Conditions

Alcoholic Hepatitis

Outcome Measures

Primary Outcomes (1)

• Survival at 3 months

  3 months

Secondary Outcomes (4)

• Improvement in SOFA (Sequential Organ Failure Assessment) score at 3 months

  3 month

• Improvement in CTP (Child Turcotte Pugh Score) score at 3 months

  3 month

• Improvement in MELD (Model for End Stage Liver Disease) score at 3 months

  3 month

• Short term mortality in both groups

  30 days

Study Arms (2)

Pentoxiphylline

EXPERIMENTAL

Drug: Pentoxiphylline

Stool Microbiota Transplantation

ACTIVE COMPARATOR

Drug: Stool microbiota transplantation

Interventions

Pentoxiphylline DRUG

Pentoxiphylline

Stool microbiota transplantation DRUG

Stool Microbiota Transplantation

Eligibility Criteria

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

You may qualify if:

• All patients with a diagnosis of severe alcoholic hepatitis who are steroid ineligible, are non responders or are intolerant
• Severe alcoholic hepatitis defined as Maddrey's Discriminant Function Score (4.6 x (PT test - control))+ S.Bilirubin in mg/dl of more than 32 OR a patient of alcoholic hepatitis (defined as AST:ALT ratio \> 2:1) who presents with any grade of hepatic encephalopathy
• Conventional therapy defined as oral steroid therapy (Wysolone ® 40mg once a day for 7 days)
• Failure of therapy defined as a Lille Model Score (http://www.lillemodel.com) of \>0.45 at day 8 of steroid therapy OR emergence of complications of steroid therapy or intolerance to steroid protocol or ineligible for steroid therapy.
• Ineligibility for steroid therapy includes - Renal dysfunction, evidence of active sepsis or foci of sepsis, gastro intestinal bleeding and disseminated intravascular coagulation, steroid intolerance, steroid related uncontrolled hyperglycemia which precludes therapy, uncontrolled diabetes mellitus
• A Psychologist will be arranged for recipients who are on Fecal Transplant protocol for psychological support throughout the period of one week, during which the transplant procedure will be performed
• Healthy persons who are willing for faeces donation have to be a close family member
• The donor will be required to give a written consent for faeces donation
• Once consent is taken, the donor will have to undergo the following screening measures:
• Clostridium difficile toxins A and B by EIA
• Routine bacterial culture for enteric pathogens in stool
• Ova and parasites
• Blood serology for viruses - human immunodeficiency virus \[HIV, type 1 and 2\] HAV IgM, HBsAg, anti HCV Ab

You may not qualify if:

• Active gastrointestinal bleeding
• Intracranial bleeding
• Multi-organ failure on mechanical ventilation
• On high inotropic support
• Paralytic ileus
• Pregnancy
• Sepsis
• Failure to provide consent
• Have abnormal bowel motions
• Have abdominal complaints
• Have symptoms indicative of irritable bowel syndrome
• Have extensive travel history or predisposing factors for potentially transmittable diseases
• Have chronic alcohol intake
• Have history of substance abuse
• Are less than 18 years or more than 60 years of age

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Hepatitis, Alcoholic

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2015
• First Posted: May 29, 2015
• Study Start: December 1, 2014
• Primary Completion: July 27, 2016
• Study Completion: July 27, 2016
• Last Updated: August 15, 2019

Record last verified: 2017-07

Locations

IN (1)