| CTRI Number |
CTRI/2017/09/009869 [Registered on: 20/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
18/09/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
This is a randomized control trial in the setup of living donor liver transplant. Here we are assessing the role of synbiotic agents (pre and probiotics) in reducing infectious complications in the immediate post-operative period after liver transplant. |
|
Scientific Title of Study
|
A Prospective Randomised controlled trial analyzing role of peri-operative synbiotic treament to prevent infectious complications in patients undergoing elective living donor liver transplant. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
shweta mallick |
| Designation |
Mch Resident(GI surgery) |
| Affiliation |
Amrita Institute of Medical Sciences and Research Centre |
| Address |
Dept. of GI Surgery, AMRITA institute of medical sciences.
Ponnekara
Ernakulam
KERALA
682041
India |
| Phone |
9535066320 |
| Fax |
09535066320 |
| Email |
shwet.mallick@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Sudhindran guide |
| Designation |
Professor department of GI Surgery and Head of Transplant |
| Affiliation |
Amrita Institute of Medical Sciences and Research Centre |
| Address |
Dept. of GI Surgery, AMRITA institute of medical sciences.
Ponnekara
Ernakulam
KERALA
682041
India |
| Phone |
9535066320 |
| Fax |
09535066320 |
| Email |
sudhisalini@icloud.com |
|
Details of Contact Person
Public Query
|
| Name |
shweta mallick |
| Designation |
Mch Resident(GI surgery) |
| Affiliation |
Amrita Institute of Medical Sciences and Research Centre |
| Address |
Dept. of GI Surgery, AMRITA institute of medical sciences.
Ponnekara
Ernakulam
KERALA
682041
India |
| Phone |
9535066320 |
| Fax |
09535066320 |
| Email |
shwet.mallick@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences & Research Centre
Ponekkara
Kochi
Kerala -682041 |
|
|
Primary Sponsor
|
| Name |
Amrita Institute of Medical Sciences Research Centre |
| Address |
Amrita Institute of Medical Sciences & Research Centre |
| 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 Shweta Mallick |
Amrita Hospital |
Department of GI & Transplant Surgery
Amrita Institute of Medical Sciences & Research centre
Ponekkara
Kochi
Ernakulam
KERALA |
9535066320
shwet.mallick@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita Institute of Medical Sciences & Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients undergoing living donor liver transplant for CLD, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Patients in the study who are administered placebo.
Patients in the control arm receive empty capsule of the same drug as a placebo in similar dosage and manner of administration. |
| Intervention |
Study group |
Patients who are administered trial drug (synbiotic agent).
The trial drug is a synbiotic (probiotic + prebiotic) drug, by the name Prowel. It contains probiotics (Lactobacillus acidus and Bifidobacterium) and prebiotics (Fructo-oligosaccharides). Patients in the study arm receive the drug 2 days prior to surgery (1capsule TDS, per orally) followed by 1 capsule TDS, per orally for 14 days after the surgery commencing on post-operative day1. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients between 18 and 70 yrs old.
2. Patients who are recipient of primary liver allografts from a living donor.
|
|
| ExclusionCriteria |
| Details |
1. Deceased donor liver transplant recepients
2.Multiorgan transplants
3.Culture proven pre-operative infection in recepient.
4.Intolerance to study medications.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of synbiotics on infection rate. |
14 days post-operatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Hospital & ICU length of stay
2 Antibiotics duration
3 30-day mortality
4 Acute graft rejection
|
14 days post-operatively. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2016 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a double blinded randomized control trail assessing the role of synbiotics in preventing infection in patients undergoing live donor liver transplant. We have included 60 patients in our trial and are currently in the process of data analysis. |