| CTRI Number |
CTRI/2025/12/099645 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of Fecal Microbiota Transplantation in the Prevention of Hepatic Encephalopathy Following TIPS in Patients with Cirrhosis |
|
Scientific Title of Study
|
Fecal microbiota transplant for primary prophylaxis of hepatic encephalopathy in patients of liver cirrhosis undergoing transjugular intrahepatic portosystemic shunt: a randomized, sham-controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalimar |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Gastroenterology Ansari Nagar
South
DELHI
110029
India |
| Phone |
09868397211 |
| Fax |
|
| Email |
drshalimar@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishal Singh Chauhan |
| Designation |
Hepatology Fellow |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Gastroenterology Ansari Nagar
South
DELHI
110029
India |
| Phone |
6395891700 |
| Fax |
|
| Email |
vishal8531@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishal Singh Chauhan |
| Designation |
Hepatology Fellow |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Gastroenterology Ansari Nagar
South
DELHI
110029
India |
| Phone |
6395891700 |
| Fax |
|
| Email |
vishal8531@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi-110029, India |
|
|
Primary Sponsor
|
| Name |
All India Institute of medical Sciences |
| Address |
Room No.127, First floor, Old OT Block, AIIMS, Ansari Nagar-110029, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shalimar |
All India Institute of Medical Sciences |
Department of Gastroenterology Ansari Nagar
South
DELHI |
09868397211
drshalimar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fecal microbiota transplantation plus Standard medical treatment |
Fresh fecal material, within 6 hours after defecation, will be used. The storage and preparation will be as brief as possible to protect the anaerobic bacteria. Until further processing, the stool sample will be stored at ambient temperature (20°C–30°C). Anaerobic storage and processing will be applied if possible. A minimum amount of 30 g of feces will be used. The fecal material will be suspended in 0.9% saline using a blender or manual effort and sieved to avoid the clogging of infusion syringes and tubes. A dedicated space, disinfected using measures that are effective against sporulating bacteria, will be used. Protective gloves and facial masks will be used during preparation
The patient will be called after overnight fast. Upper gastrointestinal endoscopy would be performed and 200 ml of fecal suspension would be deposited to patient’s duodenum part 3 or 4. The rate of deposition would be around 50ml per 2 minutes. A single session of FMT will be performed 14 days before TIPSS is created. |
| Comparator Agent |
Sham procedure plus Standard medical treatment |
Sham intervention will be carried out using 200ml normal (0.9%) saline solution. The patient will be called after overnight fast. Upper gastrointestinal endoscopy would be performed The rate of deposition would be around 50ml per 2 minutes. A single session of Sham procedure will be performed 14 days before TIPSS is done. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Cirrhosis patients undergoing TIPSS for any indications
2. Willing and able to comply with the FMT regimen and all other study requirements
3. Written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Age greater than 75 years
2. Pregnant or lactating woman
3. People living with HIV
4. Patients with low ejection fraction EF less than 50 percent
5. Those undergoing rescue or pre-emptive TIPS for variceal bleed
• Patients with severe TR, severe PAH mean Pulmonary Artery Pressure greater than 45 mmHg
• Active sepsis
• Polycystic liver disease
• Biliary obstruction
• Patients with history of congestive heart failure
• Patients with Chronic Kidney disease eGFR less than 60 ml per min per 1.73m2 for greater than 3 months
• Model for End-stage Liver disease score greater than 18
• Patients with acute-on-chronic liver failure ACLF as defined by the European Association for Study of the Liver
• Patients with hepatocellular carcinoma
• Refusal to give consent
• Concurrent diseases which would require use of antibiotics
• Patients with history of overt or persistent HE
• Any other known neurological disorders
• Other concurrent medical conditions likely to preclude compliance with the schedule of evaluations in the protocol or likely to confound the efficacy or safety observations of the study e.g., concurrent malignancies, history of unstable angina, myocardial infarction, uncontrolled asthma or diabetes, unstable thyroid disease or other significant hormonal conditions, uncontrolled seizure disorders, severe psychiatric disorders, active tuberculosis under current treatment, etc
• Any contraindication for TIPS. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of the occurrence of overt hepatic encephalopathy between the two groups at 6 months after TIPS |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Differences in the MHE by Psychometric hepatic encephalopathy score between the 2 groups at 6 months after TIPS
2.Comparison of changes in ammonia levels between the 2 groups
3. Comparison of changes in microbiome from preFMT to day 14 day of TIPS in between the 2 groups
4. Correlation of Stool microbiome with P/TIPSS HE
5. Adverse events in the two groups
6. Differences in the quality of life in the two groups using the Short Form 36 questionnaire
7. Association of sarcopenia and nutritional status with p/TIPSS HE |
1. 6 months
2. 6 months
3. 14 days
4. 6 months
5. 6 months
6. 6 months
7. 6 months |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
05/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Despite its utility in patients with cirrhosis, TIPSS has its own sets of complications that must be managed effectively to improve the overall outcome. Known complications of TIPSS include cardiac complications, worsening of liver functions and HE. Among, these complications the incidence of HE is highest and is associated with increased morbidity, hospital admissions, and cost of therapy. Studies published in the past decade have reported the incidence of post-TIPSS HE to range from 7% to 61%, and despite clinical and procedural advances there has been no overall trend toward a decrease in incidence of post-TIPSS HE over years. The pathogenesis of post-TIPSS HE is associated with an abrupt alteration in splanchnic and intrahepatic hemodynamics, along with an increased systemic burden of gut-derived toxins. Gut dysbiosis associated with cirrhosis has an important role in the pathogenesis of post-TIPSS HE. Patients undergoing TIPSS have hepatopetal blood flow towards the low-pressure shunt rather than liver parenchyma whereas the intrahepatic portal vein blood flow is hepatofugal and towards the shunt. As a result of this, there is shunting of ammonia and gut-derived toxins into the systemic circulation leading to an acute rise in ammonia and risk of post-TIPSS HE. At present the standard of care for post-TIPSS HE includes Lactulose, Rifaximin and L-ornithine L-aspartate but there is an unmet need of therapeutic options for the prevention of P-TIPSS HE. Therefore, in this RCT we plan to evaluate the role of FMT as a primary prophylaxis for HE development in cirrhosis patients undergoing TIPS |