Hepatic EncephalopathyPhase 1/2NCT02255617
Fecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): a Pilot Study
A Phase 1/2 study testing Fecal Microbiota Transplant in people with Hepatic Encephalopathy, run by University of Alberta at 1 site in Canada.
Trial summary
The purpose of this study is to determine if FMT can reverse Hepatic Encephlopathy (HE) in cirrhotic patients who continue to have breakthrough episodes of HE despite maintenance therapy with lactulose and/or rifaximin or metronidazole. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatic Encephalopathy
- What is being tested?
- Fecal Microbiota Transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- 23 Jul 2014to 23 Sep 2019
- Phase
- Phase 1/2
- 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
- adult (age > 18 years of age) cirrhotic patients of various etiology, on lactulose and/or rifaximin or flagyl for at least 4 weeks as secondary prophylaxis
- abnormal inhibitory control test, defined as greater than 5 lures.
- an infectious etiology which may cause HE has been ruled out
Who cannot join
- those with tense ascites
- those who do not provide assent
- those who are judged to have a life expectancy of less than 3 months,
- those who had TIPS within 3 months,
- those with neurologic diseases such as dementia, Parkinson's disease, and structural brain lesions
- pregnancy
Show all 13Show fewer
- those with intestinal obstruction
- those with alcoholic hepatitis
- those with active alcohol or substance abuse
- those without stable social support
- those who have a concurrent infection, such as SBP, pneumonia or UTI
- those with creatinine clearance less than 50% compared to baseline
- those with recent hospital admission, defined as within one month of enrollment, for hepatic encephalopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): a Pilot Study
The purpose of this study is to determine if FMT can reverse Hepatic Encephlopathy (HE) in cirrhotic patients who continue to have breakthrough episodes of HE despite maintenance therapy with lactulose and/or rifaximin or metronidazole.
Read the detailed description
Subjects receive FMT from a single donor by colonoscopy at Week 0 and by enema at Weeks 1-4. HE is measured by Inhibitory Control Test and Stroop as well as serum ammonia levels.
- Conditions
- Hepatic Encephalopathy
- Being tested
- Fecal Microbiota Transplant
- Medical subject headings
- Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantBiological
Fecal transplant processed from routinely screened universal donors
| Study group | Role | What they receive |
|---|---|---|
| Fecal Microbiota Transplant | Experimental | Single arm open label FMT administered at Week 0 by colonoscopy and at Weeks 1-4 by enema Receives: Biological: Fecal Microbiota Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Portion of participants with normailzation of ICT or Stroop Test during the study
Measured: 8 weeks
Secondary outcomes (7)
Proportion of patients with normalization ICT or Stroop test scores at 1 week, 2 weeks, 4 weeks and 8
Measured: 8 weeks
Changes in serum ammonia level pre and post FMT
Measured: 8 weeks
Changes in Quality of Life measured by Chronic Liver Disease Questionnaire (CDLQ) pre and post FMT
Measured: 8 weeks
Changes in Intestinal Microbiota pre and post FMT
Measured: 8 weeks
Serious Adverse Events
All serious adverse events up to and including week 8. A serious adverse event is any event which results in any of the following:
- Death ii) Colonic perforation iii) Proven infections as defined by the presence of i) spontaneous bacteremia: positive blood cultures in the absence of any other potential source of infection; ii) spontaneous bacterial peritonitis: ascetic fluid PMN equal to or greater than 250/mm3; iii) UTI: urinary leukocyte count greater than 15 cells per HPF and positive urine culture; vi) other infections identified by clinical, radiologic and bacteriologic results. iv) Possible infections as defined by i) fever (temp > 37.80 C), ii) leukocytosis (>15,000 mm3) or increased immature neutrophils in blood (>500 mm3), negative cultures and no other signs of infection.
Measured: 8 weeks
Changes in stool bile acids composition pre and post FMT
Measured: 8 Weeks
Changes in stool short chain fatty acids pre and post FMT
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study start23 Jul 2014
- Primary completion25 Jul 2019
- Study completion23 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Kao, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255617
- Sponsor's protocol ID
- 47057
- Status last verified
- Sep 2021
- First submitted
- 26 Aug 2014
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): a Pilot Study
- ClinicalTrials.gov ID
- NCT02255617
- Acronym / sponsor ID
- 47057
- Conditions
- Hepatic Encephalopathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 23 Jul 2014 (actual)
- Primary completion
- 25 Jul 2019 (actual)
- Study completion
- 23 Sep 2019 (actual)
- First posted
- 2 Oct 2014 (estimated)
- 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.
The purpose of this study is to determine if FMT can reverse Hepatic Encephlopathy (HE) in cirrhotic patients who continue to have breakthrough episodes of HE despite maintenance therapy with lactulose and/or rifaximin or metronidazole.
Detailed description
Subjects receive FMT from a single donor by colonoscopy at Week 0 and by enema at Weeks 1-4. HE is measured by Inhibitory Control Test and Stroop as well as serum ammonia levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fecal Microbiota Transplant | Experimental | Biological: Fecal Microbiota TransplantSingle arm open label FMT administered at Week 0 by colonoscopy and at Weeks 1-4 by enema |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult (age > 18 years of age) cirrhotic patients of various etiology, on lactulose and/or rifaximin or flagyl for at least 4 weeks as secondary prophylaxis
- abnormal inhibitory control test, defined as greater than 5 lures.
- an infectious etiology which may cause HE has been ruled out
Key exclusion criteria (13 listed)
- those with tense ascites
- those who do not provide assent
- those who are judged to have a life expectancy of less than 3 months,
- those who had TIPS within 3 months,
- those with neurologic diseases such as dementia, Parkinson's disease, and structural brain lesions
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 |
|---|---|---|
| Fecal Microbiota TransplantFecal transplant processed from routinely screened universal donors | Biological | Fecal Microbiota Transplant |
Primary outcome
Portion of participants with normailzation of ICT or Stroop Test during the study
Time frame: 8 weeks
7 secondary outcomes
Proportion of patients with normalization ICT or Stroop test scores at 1 week, 2 weeks, 4 weeks and 8
Time frame: 8 weeks
Changes in serum ammonia level pre and post FMT
Time frame: 8 weeks
Changes in Quality of Life measured by Chronic Liver Disease Questionnaire (CDLQ) pre and post FMT
Time frame: 8 weeks
Changes in Intestinal Microbiota pre and post FMT
Time frame: 8 weeks
Serious Adverse Events
Time frame: 8 weeks
Changes in stool bile acids composition pre and post FMT
Time frame: 8 Weeks
Changes in stool short chain fatty acids pre and post FMT
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
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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 Phase 1/2 study testing Fecal Microbiota Transplant in people with Hepatic Encephalopathy, run by University of Alberta at 1 site in Canada.
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 3 inclusion and 13 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: finished, as of the sponsor's last update on 4 Oct 2021. 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 Canada. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Portion of participants with normailzation of ICT or Stroop Test during the study (time frame: 8 weeks). 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 4 Oct 2021.