Pentoxyphilline Versus Stool Therapy in Severe Alcoholic Liver Disease

Not Applicable

Completed

• Conditions: Health Condition 1: K701- Alcoholic hepatitisHealth Condition 2: null- Severe Alcoholic Hepatitis

• Registration Number: CTRI/2016/08/007178
• Lead Sponsor: Institute of liver and Biliary Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 29

Inclusion Criteria

1) All patients with a diagnosis of severe alcoholic hepatitis who are steroid ineligible, are non responders or are intolerant

2) Severe alcoholic hepatitis defined as Maddrey Discriminant Function Score with Serum Bilirubin in mg per dl of more than 32 or a patient of alcoholic hepatitis who presents with any grade of hepatic encephalopathy

3) Conventional therapy defined as oral steroid therapy with 40mg once a day for 7 days.

4) Failure of therapy defined as a Lille Model Score of more than 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.

5) 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.

6) 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

i) Healthy persons who are willing for faeces donation have to be a close family member

ii) The donor will be required to give a written consent for faeces donation

iii) Once consent is taken, the donor will have to undergo the following screening measures:

a) Clostridium difficile toxins A and B by EIA

b) Routine bacterial culture for enteric pathogens in stool

c) Ova and parasites

d) Blood serology for viruses, human immunodeficiency virus HAV IgM, HBsAg, anti HCV Ab.

Exclusion Criteria

1)Active gastrointestinal bleeding

2)Intracranial bleeding

3)Multi-organ failure on mechanical ventilation

4)On high inotropic support

5)Paralytic ileus

6)Pregnancy

7)Sepsis

8)Failure to provide consent

9)Have abnormal bowel motions

10)Have abdominal complaints

11)Have symptoms indicative of irritable bowel syndrome

12)Have extensive travel history or predisposing factors for potentially transmittable diseases

13)Have chronic alcohol intake

14)Have history of substance abuse

15)Are less than 18 years or more than 60 years of age

16)Have HIV and Hepatitis Risk factors

17)Have enteric infections

18)Have inflammatory bowel disease history

19)Have chronic constipation or diarrhea

20)Have prior abdominal surgery or GI neoplasms

21)Have Metabolic Syndrome

22)Have Systemic Autoimmunity

23)Have atopic diseases

24)Have food and respiratory allergies

25)Have any chronic pain syndromes

26)Have chronic Neurologic disorders

27)Have Neurodevelopmental disorders

28)Have had antibiotics for any indication taken within the last 2 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified