Chronic Liver DiseaseNCT06743464
Effect of Perioperative Oral Rifaximin on Early Graft Dysfunction in Adult Living Donor Liver Transplant
A study testing Rifaximin 550 MG and SOC in people with Chronic Liver Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Liver transplantation has been a lifesaving treatment for individuals with end stage liver disease and acute liver failure. However, initial poor function of a liver allograft after liver transplantation, termed early graft dysfunction (EGD), has been associated with increased allograft loss or mortality after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Disease
- What is being tested?
- Rifaximin 550 MG and SOC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 1 Dec 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All recipients (adults) undergoing living donor liver transplant in ILBS.
Who cannot join
- Negative consent
- Hypersensitivity to Rifaximin
- Patients undergoing retransplant
- ALF, ACLF
- Pediatrics patients
- Patients on rifaximin
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Insitute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Tapan Kumar Pradhan, MS, 9970189001, tapan.ravi94@gmail.com
About this study
Official title: Effect of Perioperative Oral Rifaximin on Early Graft Dysfunction in Adult Living Donor Liver Transplant: An Open Label Randomized Control Trial
Liver transplantation has been a lifesaving treatment for individuals with end stage liver disease and acute liver failure. However, initial poor function of a liver allograft after liver transplantation, termed early graft dysfunction (EGD), has been associated with increased allograft loss or mortality after transplantation. EGD in LDLT is multifactorial. Factors affecting EGD are GRWR, ischemia reperfusion injury, recipient metabolic demand, graft quality, graft inflow and outflow. Studies shows that the incidence of EGD is 15-38%. It is associated with increased allograft loss \& mortality. Rifaximin is an antibiotic that reduces EGD by 50% as shown by 2 studies but this study was done in DDLT setting and rifaximin was given in the pretransplant group.
In this investigators will study the effect of perioperative oral rifaximin on early graft dysfunction in adult living donor liver transplant.
Read the detailed description
Methodology:
- Study population: All patients undergoing adult living donor liver transplant recipients
- Study design: Open label Randomized control Study
- Study period: After ethical board clearance, all LDLT recipients satisfying inclusion criteria till June 2025
- Sample size: n=100
- Intervention: Preoperative Rifaximin supplementation 550 mg twice daily from preoperatively 2 weeks to post op POD 1 to 7
- Monitoring and assessment: Not valid
- Adverse effects: No adverse effect is expected to occur out of study protocols. except vomiting, headache, dizziness, nausea
- Stopping rule Not valid (b) Expected outcome of the project: Perioperative oral rifaximin decreases early allograft dysfunction in recipients of adult living donor liver transplant. (c) Ethical issues in the study and plans to address these issues: None expected
- Conditions
- Chronic Liver Disease
- Being tested
- Rifaximin 550 MG, SOC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifaximin 550 MGDrug
Preoperative Rifaximin supplementation 550 mg twice daily from preoperatively 2 weeks to post op POD 1 to 7
SOCOther
SOC means Standard of care which means that the patient will revieve standard post op care followed at our insitute and other hospitals in India.
| Study group | Role | What they receive |
|---|---|---|
| Rifaximin+SOC | Experimental | Preoperative Rifaximin supplementation 550 mg twice daily from preoperatively 2 weeks to post op POD 1 to 7 SOC (Standard of care) means both group will recieve similar post of care which is standard protocol at ILBS. Receives: Drug: Rifaximin 550 MG; Other: SOC |
| Non Rifaximin + SOC | Active comparator | SOC (Standard of care) means both group will recieve similar post of care which is standard protocol at ILBS. Receives: Other: SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative oral rifaximin on early graft dysfunction in adult living donor liver transplant.
The study aims to see the effect of peri-operative (before transplant and post transplant) rifaximin on early graft dysfunction. Preoperatively investigators will be giving Tab rifaximin supplementation 550 mg twice daily from preoperatively 2 weeks to post op POD 1 to 7 while the other arm will not be given rifaximin.
Early graft dysfunction is identified using modified altoff criteria, Pamecha et al. creteria(Early graft dysfunction in diseased donor liver transplant and living donor liver transplant)
- T. Bilirubin >10
- Urea
- INR > 1.6
- AST/ALT > 2000
Measured: 9 months
Secondary outcomes (4)
To evaluate the effect of rifaximin on early graft dysfunction
Investigators will study the indirect markers for early graft dysfuntion which were recently discovered and the role of rifaximin on the markers. Investigators will do all this in the living donor liver transplant setting
Measured: 9 months
Ischemia reperfusion injury markers (Cathepsin G, CD 86)
Investigators will study the indirect markers for early graft dysfuntion which were recently discovered and the role of rifaximin on the markers. Investigators will do all this in the living donor liver transplant setting
Measured: 9 months
EAD (IL6, IL17)
Investigators will study the indirect markers for early graft dysfuntion which were recently discovered and the role of rifaximin on the markers. Investigators will do all this in the living donor liver transplant setting
Measured: 9 months
To study the effect of perioperative oral rifaximin on infectious complications, EGD related graft loss and in-hospital mortality.
Investigators will study the indirect markers for early graft dysfuntion which were recently discovered and the role of rifaximin on the markers. Investigators will do all this in the living donor liver transplant setting
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Dec 2024
- Primary completion10 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743464
- Sponsor's protocol ID
- ILBS-LDLT-03
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 5 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Oral Rifaximin on Early Graft Dysfunction in Adult Living Donor Liver Transplant: An Open Label Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06743464
- Acronym / sponsor ID
- ILBS-LDLT-03
- Conditions
- Chronic Liver Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Liver transplantation has been a lifesaving treatment for individuals with end stage liver disease and acute liver failure. However, initial poor function of a liver allograft after liver transplantation, termed early graft dysfunction (EGD), has been associated with increased allograft loss or mortality after transplantation. EGD in LDLT is multifactorial. Factors affecting EGD are GRWR, ischemia reperfusion injury, recipient metabolic demand, graft quality, graft inflow and outflow. Studies shows that the incidence of EGD is 15-38%. It is associated with increased allograft loss \& mortality. Rifaximin is an antibiotic that reduces EGD by 50% as shown by 2 studies but this study was done in DDLT setting and rifaximin was given in the pretransplant group.
In this investigators will study the effect of perioperative oral rifaximin on early graft dysfunction in adult living donor liver transplant.
Detailed description
Methodology:
- Study population: All patients undergoing adult living donor liver transplant recipients
- Study design: Open label Randomized control Study
- Study period: After ethical board clearance, all LDLT recipients satisfying inclusion criteria till June 2025
- Sample size: n=100
- Intervention: Preoperative Rifaximin supplementation 550 mg twice daily from preoperatively 2 weeks to post op POD 1 to 7
- Monitoring and assessment: Not valid
- Adverse effects: No adverse effect is expected to occur out of study protocols. except vomiting, headache, dizziness, nausea
- Stopping rule Not valid (b) Expected outcome of the project: Perioperative oral rifaximin decreases early allograft dysfunction in recipients of adult living donor liver transplant. (c) Ethical issues in the study and plans to address these issues: None expected
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rifaximin+SOC | Experimental | Drug: Rifaximin 550 MG, Other: SOCPreoperative Rifaximin supplementation 550 mg twice daily from preoperatively 2 weeks to post op POD 1 to 7 SOC (Standard of care) means both group will recieve similar post of care which is standard protocol at ILBS. |
| Non Rifaximin + SOC | Active comparator | Other: SOCSOC (Standard of care) means both group will recieve similar post of care which is standard protocol at ILBS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All recipients (adults) undergoing living donor liver transplant in ILBS.
Key exclusion criteria (6 listed)
- Negative consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rifaximin 550 MGPreoperative Rifaximin supplementation 550 mg twice daily from preoperatively 2 weeks to post op POD 1 to 7 | Drug | Rifaximin+SOC |
| SOCSOC means Standard of care which means that the patient will revieve standard post op care followed at our insitute and other hospitals in India. | Other | Non Rifaximin + SOC, Rifaximin+SOC |
Primary outcome
Perioperative oral rifaximin on early graft dysfunction in adult living donor liver transplant.
Time frame: 9 months
The study aims to see the effect of peri-operative (before transplant and post transplant) rifaximin on early graft dysfunction. Preoperatively investigators will be giving Tab rifaximin supplementation 550 mg twice daily from preoperatively 2 weeks to post op POD 1 to 7 while the other arm will not be given rifaximin. Early graft dysfunction is identified using modified altoff criteria, Pamecha et al. creteria(Early graft dysfunction in diseased donor liver transplant and living donor liver transplant) 1. T. Bilirubin >10 2. Urea 3. INR > 1.6 4. AST/ALT > 2000
4 secondary outcomes
To evaluate the effect of rifaximin on early graft dysfunction
Time frame: 9 months
Ischemia reperfusion injury markers (Cathepsin G, CD 86)
Time frame: 9 months
EAD (IL6, IL17)
Time frame: 9 months
To study the effect of perioperative oral rifaximin on infectious complications, EGD related graft loss and in-hospital mortality.
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rifaximin 550 MG and SOC in people with Chronic Liver Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tapan Kumar Pradhan, MS (9970189001, tapan.ravi94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative oral rifaximin on early graft dysfunction in adult living donor liver transplant. (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.