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Pentoxyphilline Versus Fecal Microbiota Therapy in Severe Alcoholic Hepatitis

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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

32

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Delhi
      • New Delhi, Delhi, Indien, 110070
        • Institute of liver and Biliary Sciences

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Pentoxiphylline
Aktiv komparator: Stool Microbiota Transplantation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Survival at 3 months
Tidsramme: 3 months
3 months

Sekundære resultatmål

Resultatmål
Tidsramme
Improvement in SOFA (Sequential Organ Failure Assessment) score at 3 months
Tidsramme: 3 month
3 month
Improvement in CTP (Child Turcotte Pugh Score) score at 3 months
Tidsramme: 3 month
3 month
Improvement in MELD (Model for End Stage Liver Disease) score at 3 months
Tidsramme: 3 month
3 month
Short term mortality in both groups
Tidsramme: 30 days
30 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2014

Primær færdiggørelse (Faktiske)

27. juli 2016

Studieafslutning (Faktiske)

27. juli 2016

Datoer for studieregistrering

Først indsendt

23. maj 2015

Først indsendt, der opfyldte QC-kriterier

27. maj 2015

Først opslået (Skøn)

29. maj 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. august 2019

Sidst verificeret

1. juli 2017

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Alkoholisk hepatitis

Kliniske forsøg med Pentoxiphylline

Abonner