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Pentoxyphilline Versus Fecal Microbiota Therapy in Severe Alcoholic Hepatitis

Primary Purpose

Alcoholic Hepatitis

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Pentoxiphylline
Stool microbiota transplantation
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholic Hepatitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

    1. Healthy persons who are willing for faeces donation have to be a close family member
    2. The donor will be required to give a written consent for faeces donation

    3. Once consent is taken, the donor will have to undergo the following screening measures:

      1. Clostridium difficile toxins A and B by EIA
      2. Routine bacterial culture for enteric pathogens in stool
      3. Ova and parasites
      4. Blood serology for viruses - human immunodeficiency virus [HIV, type 1 and 2] HAV IgM, HBsAg, anti HCV Ab

Exclusion Criteria:

  • 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
  • Have HIV and Hepatitis Risk factors
  • Have enteric infections
  • Have inflammatory bowel disease history
  • Have chronic constipation or diarrhea
  • Have prior abdominal surgery or GI neoplasms
  • Have Metabolic Syndrome
  • Have Systemic Autoimmunity
  • Have atopic diseases
  • Have food and respiratory allergies
  • Have any chronic pain syndromes
  • Have chronic Neurologic disorders
  • Have Neurodevelopmental disorders
  • Have had antibiotics for any indication taken within the last 2 months

Sites / Locations

  • Institute of Liver and Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pentoxiphylline

Stool Microbiota Transplantation

Arm Description

Outcomes

Primary Outcome Measures

Survival at 3 months

Secondary Outcome Measures

Improvement in SOFA (Sequential Organ Failure Assessment) score at 3 months
Improvement in CTP (Child Turcotte Pugh Score) score at 3 months
Improvement in MELD (Model for End Stage Liver Disease) score at 3 months
Short term mortality in both groups

Full Information

First Posted
May 23, 2015
Last Updated
August 14, 2019
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT02458079
Brief Title
Pentoxyphilline Versus Fecal Microbiota Therapy in Severe Alcoholic Hepatitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
December 1, 2014 (Actual)
Primary Completion Date
July 27, 2016 (Actual)
Study Completion Date
July 27, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Hepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pentoxiphylline
Arm Type
Experimental
Arm Title
Stool Microbiota Transplantation
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Pentoxiphylline
Intervention Type
Drug
Intervention Name(s)
Stool microbiota transplantation
Primary Outcome Measure Information:
Title
Survival at 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Improvement in SOFA (Sequential Organ Failure Assessment) score at 3 months
Time Frame
3 month
Title
Improvement in CTP (Child Turcotte Pugh Score) score at 3 months
Time Frame
3 month
Title
Improvement in MELD (Model for End Stage Liver Disease) score at 3 months
Time Frame
3 month
Title
Short term mortality in both groups
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Have HIV and Hepatitis Risk factors Have enteric infections Have inflammatory bowel disease history Have chronic constipation or diarrhea Have prior abdominal surgery or GI neoplasms Have Metabolic Syndrome Have Systemic Autoimmunity Have atopic diseases Have food and respiratory allergies Have any chronic pain syndromes Have chronic Neurologic disorders Have Neurodevelopmental disorders Have had antibiotics for any indication taken within the last 2 months
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India

12. IPD Sharing Statement

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Pentoxyphilline Versus Fecal Microbiota Therapy in Severe Alcoholic Hepatitis

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