Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-24 @ 3:33 PM
NCT ID:
NCT05285592
Eligibility Criteria:
Inclusion Criteria:
1. Steroid ineligible severe alcoholic hepatitis as per definition
2. Informed consent
3. Age 18 - 70 years
4. Liver biopsy -if Feasible
5. Model for End-Stage Liver Disease (MELD) ≥ 20 and Maddrey DF ≥ 32
Exclusion Criteria:
1. UGI Bleed within last one month
2. More then 3 organ failure requiring support
3. Mechanically ventilated patient , (patients requiring ICU/ HDU care) (On inotropic support)
4. Uncontrolled sepsis, DIC
5. Gut paralysis
6. Active hepatic or extra hepatic malignancy
7. Renal failure creatinine \> 2.5
8. DF\>120
9. MELD \>35
10. Prior SBP/active SBP
11. Intestinal conditions like IBD, SIBO
Donor evaluation The subjects will be screened for
1. Routine laboratory tests (CBC; LFT; KFT; PT; INR)
2. Fasting blood sugar
3. Lipid profile
4. HBsAg
5. Anti-HCV
6. HIV 1 \& 2
7. VDRL
8. Stool routine and microscopy stool ova \& cysts.
9. Stool culture
10. Clostridium difficile toxin
11. Helicobacter pylori stool antigen
12. 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05285592
Study Brief:
Protocol Section:
NCT05285592