Pentoxyphilline Versus Fecal Microbiota Therapy in Severe Alcoholic Hepatitis

Institute of Liver and Biliary Sciences, India

Status

Completed

Conditions

Alcoholic Hepatitis

Treatments

Drug: Pentoxiphylline

Drug: Stool microbiota transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT02458079

ILBS-AH-02

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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