NCT03091010

Brief Summary

Study population: Patients attending the Out Patient Department and admitted to Institute of Liver and Biliary Sciences. Study design: Prospective randomized controlled trial Study period: One year- January 2017- December 2018 Sample size: 130 (65 cases in each group) Intervention: The subjects will be given Fecal Microbiota Transplantation through a NJ tube placed after admission to the hospital. Participants will be administered the processed fecal microbiota sample collected from a related or unrelated healthy donor for a period of 7 days. Monitoring and assessment: The recipient will be monitored every day after Fecal Microbiota Transplantation therapy. The recipient will undergo physical examination, complete blood counts, at baseline and a chest X ray, serum procalcitonin, CRP and Tumor Necrosis Factor alpha levels, Liver Function Tests, Kidney Function Tests, International Normalized Ratio and arterial ammonia, at day 0,4,7,14,28,90,180,270 and 365 from the start of therapy. Microbiota analysis of the donors will be done at baseline and the recipients will be done on day 0,7,28,90 \& 180.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 27, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

April 8, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

January 22, 2020

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

March 9, 2017

Last Update Submit

January 21, 2020

Conditions

Severe Alcoholic Hepatitis

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants with Overall Survival at 3 months

    3 months

Secondary Outcomes (5)

  • Improvement in Child Pugh Turcotte (score) severity in both groups

    6 months

  • Improvement in Model for End Stage Liver Disease (MELD) of liver disease severity in both groups

    6 months

  • Improvement in Glasgow Alcoholic Hepatitis (score) in both groups

    6 months

  • Improvement in Maddrey's Discriminant Function (score) in both groups

    6 months

  • Adverse events in both groups

    6 months

Study Arms (2)

Fecal Microbiota Transplantation

EXPERIMENTAL
Other: Fecal Microbiota Transplantation

Steroid

ACTIVE COMPARATOR
Drug: Steroids

Interventions

Fecal Microbiota TransplantationOTHER

Fecal Microbiota Transplantation will be given 100mL of suspension. It will given for a period of 7 days

Fecal Microbiota Transplantation
SteroidsDRUG

Oral steroids 40 mg (prednisolone) will be given for a period of 7 days in hospital followed by 3 weeks on OPD basis

Steroid

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with severe alcoholic hepatitis .
  • Eligible for steroid therapy.

You may not qualify if:

  • Upper gastrointestinal bleed within the past one month.
  • Active sepsis
  • Serum creatinine \> 1.5 mg/dl (Hepato renal syndrome)
  • Intestinal paralysis
  • Hepatic or extrahepatic malignancy
  • Disseminated intravascular coagulation
  • Discriminant Function (DF) \>90

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver and Biliary Sciences

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

Location

MeSH Terms

Conditions

Hepatitis, Alcoholic

Interventions

Fecal Microbiota TransplantationSteroids

Condition Hierarchy (Ancestors)

HepatitisLiver DiseasesDigestive System DiseasesLiver Diseases, AlcoholicAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeuticsFused-Ring CompoundsPolycyclic Compounds

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

March 9, 2017

First Posted

March 27, 2017

Study Start

April 8, 2017

Primary Completion

March 24, 2019

Study Completion

June 30, 2020

Last Updated

January 22, 2020

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)