Acute Liver FailureNCT03363022
To Assess the Role of Fecal Microbiota Transplant in Acute Liver Failure
A study testing Standard Medical Treatment and Fecal Microbiota Transplant in people with Acute Liver Failure, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
All patients of Acute liver failure not meeting the KCH (King's College Hospital) criteria/or meeting KCH criteria not having option of liver transplant will be recruited for the trial. The first group will receive Standard medical care with Fecal Microbiota transplant on Day 1 for 3 consecutive days. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Liver Failure
- What is being tested?
- Standard Medical Treatment and Fecal Microbiota Transplant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- 1 Feb 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute liver failure -Not meeting KCH Criteria/Meeting KCH Criteria but not having Liver transplant option
Who cannot join
- Culture Positive Sepsis
- History of taking lactulose, rifaximin, neomycin, metronidazole, L-Ornithine L-Aspartate
- Receiving psychoactive drugs, promotility and hypomotility drugs
- Pregnant females
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: To Assess the Role of Fecal Microbiota Transplant in Acute Liver Failure- A Double Blind Controlled Trial
All patients of Acute liver failure not meeting the KCH (King's College Hospital) criteria/or meeting KCH criteria not having option of liver transplant will be recruited for the trial. The first group will receive Standard medical care with Fecal Microbiota transplant on Day 1 for 3 consecutive days. FMT (Fecal Microbiota Transplant) will be delivered rectally which will be placed bedside. Suitable donor will be screened and the stool samples will be used as per criteria. Stool samples will be taken at the time at Day 0, 1(Post FMT), Day 4, 6, 14,21. Sepsis screen will be sent. Inflammatory markers will be sent on Day 0,1, 4,6, 14,21. The second group will receive standard medical therapy/and an placebo. Stool samples will be sent on Day 0,1, 4, 6 , 14,21. Inflammatory markers will be sent on the time on day 0,1 4,6 , 14,21.
- Conditions
- Acute Liver Failure
- Being tested
- Standard Medical Treatment, Fecal Microbiota Transplant, Placebo
- Medical subject headings
- Liver Failure, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Medical TreatmentDrug
Standard Medical Treatment includes antibiotics,CRRT (Continuous Renal replacement Therapy),Liver Dialysis.
Fecal Microbiota TransplantOther
Fecal Microbiota Transplant Stool specimen (preferably Bristol Stool Type 3 or 4) with a weight of ∼50 g will be considered adequate.
250 mL sterile normal saline will be added to the stool sample and homogenized with a blender for 2-4minutes in pulses of 30 seconds with 10 seconds wait in between each pulse.
Enema to be held for 30 minutes.
PlaceboOther
Placebo will be identical and non medicinal to the Fecal Microbiota Transplant
| Study group | Role | What they receive |
|---|---|---|
| Standard Medical Treatment+Fecal Microbiota Transplant | Experimental | Not described Receives: Drug: Standard Medical Treatment; Other: Fecal Microbiota Transplant |
| Standard Medical Treatment+Placebo | Active comparator | Not described Receives: Drug: Standard Medical Treatment; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival in both groups
Measured: Day 21
Secondary outcomes (4)
Resolution of SIRS (Systemic Inflammatory Response Syndrome) in both groups
Measured: Day 1,2,5,7,14,21
Reduction of ammonia in both groups
Measured: Day 1,2,5,7,14,21
Improvement of Cerebral edema in both groups
Improvement is defined as transcranial doppler < 0.9/Features suggestive of edema in CT imaging
Measured: Day 1,2,5,7,14,21
Improvement in SOFA (Sequential Organ Failure Assessment) Score in both groups
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start1 Feb 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: Lack of Funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Liver FailureStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
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
- NCT03363022
- Sponsor's protocol ID
- ILBS-ALF-04
- Status last verified
- Nov 2019
- First submitted
- 23 Sep 2017
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the Role of Fecal Microbiota Transplant in Acute Liver Failure- A Double Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT03363022
- Acronym / sponsor ID
- ILBS-ALF-04
- Conditions
- Acute Liver Failure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of Funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 5 Dec 2017 (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.
All patients of Acute liver failure not meeting the KCH (King's College Hospital) criteria/or meeting KCH criteria not having option of liver transplant will be recruited for the trial. The first group will receive Standard medical care with Fecal Microbiota transplant on Day 1 for 3 consecutive days. FMT (Fecal Microbiota Transplant) will be delivered rectally which will be placed bedside. Suitable donor will be screened and the stool samples will be used as per criteria. Stool samples will be taken at the time at Day 0, 1(Post FMT), Day 4, 6, 14,21. Sepsis screen will be sent. Inflammatory markers will be sent on Day 0,1, 4,6, 14,21. The second group will receive standard medical therapy/and an placebo. Stool samples will be sent on Day 0,1, 4, 6 , 14,21. Inflammatory markers will be sent on the time on day 0,1 4,6 , 14,21.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Medical Treatment+Fecal Microbiota Transplant | Experimental | Drug: Standard Medical Treatment, Other: Fecal Microbiota Transplant |
| Standard Medical Treatment+Placebo | Active comparator | Drug: Standard Medical Treatment, Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acute liver failure -Not meeting KCH Criteria/Meeting KCH Criteria but not having Liver transplant option
Key exclusion criteria (4 listed)
- Culture Positive Sepsis
- History of taking lactulose, rifaximin, neomycin, metronidazole, L-Ornithine L-Aspartate
- Receiving psychoactive drugs, promotility and hypomotility drugs
- Pregnant females
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 |
|---|---|---|
| Standard Medical TreatmentStandard Medical Treatment includes antibiotics,CRRT (Continuous Renal replacement Therapy),Liver Dialysis. | Drug | Standard Medical Treatment+Fecal Microbiota Transplant, Standard Medical Treatment+Placebo |
| Fecal Microbiota TransplantFecal Microbiota Transplant Stool specimen (preferably Bristol Stool Type 3 or 4) with a weight of ∼50 g will be considered adequate. 250 mL sterile normal saline will be added to the stool sample and homogenized with a blender for 2-4minutes in pulses of 30 seconds with 10 seconds wait in between each pulse. Enema to be held for 30 minutes. | Other | Standard Medical Treatment+Fecal Microbiota Transplant |
| PlaceboPlacebo will be identical and non medicinal to the Fecal Microbiota Transplant | Other | Standard Medical Treatment+Placebo |
Primary outcome
Survival in both groups
Time frame: Day 21
4 secondary outcomes
Resolution of SIRS (Systemic Inflammatory Response Syndrome) in both groups
Time frame: Day 1,2,5,7,14,21
Reduction of ammonia in both groups
Time frame: Day 1,2,5,7,14,21
Improvement of Cerebral edema in both groups
Time frame: Day 1,2,5,7,14,21
Improvement in SOFA (Sequential Organ Failure Assessment) Score in both groups
Time frame: Day 21
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Individual participant dataSharing planned: No
Related trials for Acute Liver Failure
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
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CytOSorb TreatMent Of Critically Ill PatientS Registry
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Medical Treatment and Fecal Microbiota Transplant in people with Acute Liver Failure, 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 4 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: withdrawn, as of the sponsor's last update on 5 Nov 2019. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival in both groups (time frame: Day 21). 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 Nov 2019.