- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05285592
Fecal Microbiota Therapy in Steroid Ineligible Alcoholic Hepatitis
Fecal Microbiota Therapy in Steroid Ineligible Alcoholic Hepatitis: A Randomized Controlled Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
AIM- To assess survival benefit at 3 month, in patients of severe alcoholic hepatitis who are steroid ineligible.
Methodology:
Study population: Fecal microbiota therapy in steroid ineligible Alcoholic hepatitis: Randomized controlled trial.
Study design:
A prospective, randomized controlled trial. The study will be conducted on the consecutive patients presenting with severe Alcoholic hepatitis to the wards of Department of Hepatology, ILBS, New Delhi from feb 2022 to February 2023 who meet the inclusion criteria.
Study period: 2 years from the date of ethics approval
Techinue for FMT Healthy donor will be screen as per ILBS FMT proforma- donor should be from family and emotionly attached.
Stool collection
- Donors will be supplied clean, sealable containers for collection and transport of stool. Containers will be labeled with the name, UHID and date/time of stool collection.
- Collected stool will be immediately transferred to the laboratory facility for processing and used within 6 hours collection
- Stool sample from Healthy donor will be processed
- Patient preparation
- Patient was kept NPO for 4 hours prior to stool instillation
- Iv antibiotics were continued as per treating doctor in the event of sepsis
- The patient was allowed to consume the prescribed diet 2 hours after the procedure instillation
- Methods of FMT infusion.
- Seven doses (30gm one dose) of FMT will be given via jejunal port of NJ/NG tube
Sample size with justification:
Assuming that the survival in FMT group is 87.5% and 33% in SMT Group with alpha 5 %, power 95% we need to enroll 52 in FMT group and 26 in SMT Group so that the FMT versus SMT ration is 2. Further assuming 5% defaulter rate /drop out rate we decided to enroll 56 and 28 on FMT and SMT arm.We will enroll 84 patients, block size of 6
Intervention:
- Patients will be randomized into two Arms A & B.
- Arm A will receive fecal microbioata therapy for 7 Days, Seven doses (30gm stool prepared in 100 ml Ns everyday as described ) of FMT will be given via jejunal port of NJ/NG tube.
- Arm B will receive standard medical therapy.
- Patient preparation in Arm A
- Patient was kept NPO for 4 hours prior to stool instillation
- Iv antibiotics were continued as per treating doctor in the event of sepsis
- The patient will be allowed to consume the prescribed diet 2 hours after the procedure.
- Both groups received Antibiotics, multivitamins, albumin infusions, nutrition will be used as per clinical discretion in both groups.
Data to be collected:
- Baseline - CBC, LFT, RFT, Serum albumin, total protein, Chest X Ray, Serum electrolytes, PT, INR baseline and then for first 7 days then at 28 days ,90 and 180 days then whenever needed
- PCT and CRP baseline and whenever needed
- Amylase, lipase baseline if needed
- HIV,IgM,HAV Ab,IgM HEV, HBsAg, HB core Ab (total),AntiHCV- baseline
- Blood cultures x2- baseline and whenever needed
- Urine culture & urinalysis-Baseline and whenever needed
- Ascites for albumin, total protein, TLC cell count and differential, SAAG, G/S, C/s (if present)
- TNF alpha, TGF B, IL 1, IL 6, IL22 baseline then at 28 days,90 and 180 days.
- Stool studies (if diarrhea): C. difficile, culture,
- stool Microbioata analysis baseline and whenever needed
- Glucose H2 Breath test if needed
- UGI endoscopy with (D2 biopsy/Aspirate whenever feasible), and NJ placement done at baeline for FMT insertion.
- Complete abdominal ultrasound or cross-sectional radiology
- Liver Biopsy (If Feasible)
Statistical Analysis:
Data will be reported as mean + SD. Categorical variables will be compared using the chi-square test or Fisher exact test. Normal continuous variables will be compared using the Student's t test Non normal continuous variables will be compared using the Mann Whitney rank-sum test (unpaired data) or the Wilcoxon test (paired data). The actuarial probability of survival will be calculated by the Kaplan-Meier method and compared using the log-rank test. A Cox regression analysis will be performed to identify independent prognostic factors for survival.Univariate and multivariate analysis will be used whenever applicable.
Adverse effects:
Side effects related to FMT will be noted. Abdominal Pain, Bloating, loss of appetite Gas/Flatulence, Constipation, Diarrhea , Nausea ,Vomiting Fever
Stopping rule of study:
- New onset infection (sepsis)
- Patient refusal After starting Therapy
- Liver transplantation
Expected outcome of the project-Modulation of gut microbiota and correction of dysbiosis in severe Alcoholic hepatitis through healthy donor Fecal Implantation therapy improves gut dysbiosis and provide survival benefit at 3 months
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dr Rahul Khajuria, MD
- Phone Number: 01146300000
- Email: dr.rahulkhajuria@gmail.com
Study Locations
-
-
Delhi
-
New Delhi, Delhi, India, 110070
- Recruiting
- Institute of Liver & Biliary Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Steroid ineligible severe alcoholic hepatitis as per definition
- Informed consent
- Age 18 - 70 years
- Liver biopsy -if Feasible
- Model for End-Stage Liver Disease (MELD) ≥ 20 and Maddrey DF ≥ 32
Exclusion Criteria:
- UGI Bleed within last one month
- More then 3 organ failure requiring support
- Mechanically ventilated patient , (patients requiring ICU/ HDU care) (On inotropic support)
- Uncontrolled sepsis, DIC
- Gut paralysis
- Active hepatic or extra hepatic malignancy
- Renal failure creatinine > 2.5
- DF>120
- MELD >35
- Prior SBP/active SBP
- Intestinal conditions like IBD, SIBO
Donor evaluation The subjects will be screened for
- Routine laboratory tests (CBC; LFT; KFT; PT; INR)
- Fasting blood sugar
- Lipid profile
- HBsAg
- Anti-HCV
- HIV 1 & 2
- VDRL
- Stool routine and microscopy stool ova & cysts.
- Stool culture
- Clostridium difficile toxin
- Helicobacter pylori stool antigen
- Cryptosporidium & Isospora (acid fast stain) Exclusion criteria for Donor
1. Antibiotic usage within 3 months of enrollment 2. Gastroenteritis within last 2 months 3. Obesity 4. Diabetes mellitus 5. Inflammatory bowel disease 6. Any Malignancy 7. Chronic Kidney disease, Coronary artery disease 8. Cerebrovascular accident or chronic obstructive pulmonary disease 9. HBsAg, Anti HCV, HIV seropositivity 10. Transaminitis, dyslipidemia 11. Ova or cyst in stool, C. difficile toxin Positive 12. Chronic alcohol intake 13. Active substance abuse
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fecal Transplantation
|
Fecal Transplantation
|
Active Comparator: Standard Medical Treatment
|
Standard Medical Treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mortality at 3 months
Time Frame: 3 months
|
3 months
|
Liver transplant free survival
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mortality
Time Frame: 1 month
|
1 month
|
End of study period
Time Frame: 6 months
|
6 months
|
Post therapy assessment in the form of clinical improvement (hepatic encephalopathy, ascites , improvement in jaundice)(both ascites and HE if present)
Time Frame: 6 months
|
6 months
|
Frequency of decompensation events on follow up period
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Digestive System Diseases
- Alcohol-Related Disorders
- Substance-Related Disorders
- RNA Virus Infections
- Virus Diseases
- Infections
- Liver Diseases
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Liver Diseases, Alcoholic
- Alcohol-Induced Disorders
- Hepatitis
- Hepatitis A
- Hepatitis, Alcoholic
Other Study ID Numbers
- ILBS-Alcoholic Hepatitis-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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