Liver CirrhosisPhase 2/3CHiFTNCT04932577
Faecal Microbiota Transplantation for Liver Cirrhosis
A Phase 2/3 study testing Faecal microbiota transplantation in people with Liver Cirrhosis, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose is to investigate the effect of faecal microbiota transplantation (FMT) on complications, progression, and mortality of patients with liver cirrhosis. Further, the investigators want to examine the impact of FMT on the gut microbiota, gut barrier function, systemic inflammation, and immune function. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Faecal microbiota transplantation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2021to 31 May 2027
- Phase
- Phase 2/3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Liver cirrhosis with Child-Pugh ≤ 12
- Acute decompensation requiring intervention (ascites, gastrointestinal bleeding, infections leading to progressive liver failure, overthepatic encephalopathy, alcoholic hepatitis)
Who cannot join
- More than one organ failure defined by CLIF-SOFA score
- Untreated malignancy apart from non-melanoma skin cancer
- Untreated viral hepatitis
- HIV
- Inflammatory bowel disease
- Celiac disease
Show all 9Show fewer
- Clostridioides Difficile infection
- Pregnancy
- Unable to participate based on medical judgement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Hepatology and Gastroenterology, Aarhus University Hospital
Aarhus, 8200
Karen Louise Thomsen, PhD, +4526949260, karethom@rm.dk
About this study
Official title: Faecal Microbiota Transplantation to Prevent Complications, Progression and Mortality of Liver Cirrhosis
The purpose is to investigate the effect of faecal microbiota transplantation (FMT) on complications, progression, and mortality of patients with liver cirrhosis. Further, the investigators want to examine the impact of FMT on the gut microbiota, gut barrier function, systemic inflammation, and immune function.
Read the detailed description
Patients with liver disease have a disturbed gut microbiota. This is often associated with disease progression and development of complications, so-called episodes of decompensation. In this trial, we will change the microbiota of these patients by transferring a healthy microbiota through faeces from a healthy donor, a procedure known as faecal microbiota transplantation (FMT). We will examine the effect of FMT on the prognosis and disease progression of the patients. Further, we will examine the mechanistic effects of FMT. We will at random divide 220 patients admitted with decompensation of liver cirrhosis evenly into two groups. One group will receive FMT and the other group will receive placebo. After the treatment, we will follow the patients for one year and examine disease progression as well as changes in their gut microbiota, gut barrier, and immune function.
- Conditions
- Liver Cirrhosis
- Being tested
- Faecal microbiota transplantation, Placebo
- Keywords
- Hepatic encephalopathy, Ascites, Gastrointestinal bleeding, Spontaneous bacterial peritonitis, Hepatorenal syndrome, Alcoholic hepatitis
- Medical subject headings
- Liver Cirrhosis, Hepatic Encephalopathy, Ascites, Gastrointestinal Hemorrhage, Hepatorenal Syndrome, Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faecal microbiota transplantationBiological
Also called FMT
All participant will receive three applications of either FMT or placebo and afterwards followed for 1 year.
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Faecal microbiota transplantation | Experimental | The patients will receive three applications of FMT consisting of 50 g cryopreserved, homogenized faeces from healthy donors. The faecal material will be dispensed into double-coated, acid-resistant enterocapsules or cryobags. Faeces will be screened according to international guidelines. Receives: Biological: Faecal microbiota transplantation |
| Placebo | Placebo comparator | The placebo products is produced from a suspension of glycerol, saline and food colouring and cannot be distinguished from the active FMT products. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to death or new episode of acute decompensation requiring intervention in FMT versus placebo-treated patients.
Using data from the patient journals, we will be able to examine the exact time to event in each of the patients. To compare the two groups, hazard ratios will be calculated.
Measured: 1 year
Secondary outcomes (16)
Time to death or new episode of acute decompensation requiring intervention in FMT versus placebo-treated patients at 3 months and 6 months of follow-up.
Using data from the patient journals, we will be able to examine the exact time to event in each of the patients. To compare the two groups, hazard ratios will be calculated.
Measured: 3 months, 6 months
Number of new decompensations and deaths during follow-up in the FMT versus the placebo-treated patients.
Incidence rates will be compared between the groups.
Measured: 1 year
Time to death in FMT versus placebo-treated patients. -treated patients at 3 months and 6 months of follow-up.
Using data from the patient journals, we will be able to examine the exact time to event in each of the patients. To compare the two groups, hazard ratios will be calculated.
Measured: 1 year, 6 months, 3 months
Change in gut microbiota beta-diversity (Bray-Curtis index) during one year in FMT versus placebo-treated patients by shotgun metagenomic sequencing.
In stool and saliva samples collected before and at 5 time points following the intervention, we will measure the gut microbiota composition.
Measured: 1 year, 6 months, 3 months
Change in plasma concentration of gut translocation markers; lipopolysaccharide binding protein, soluble CD14, fatty acid binding protein 1 during one year in FMT versus placebo-treated patients by ELISA.
In blood samples collected at baseline and at follow-up visits, we will measure these plasma proteins by ELISA.
Measured: 1 year, 6 months, 3 months
Change in plasma and stool concentration of pro- and antiinflammatory cytokines; IL-6, IL-1beta, TNF-alpha, IL-8, IL-10 in response to the intervention by luminex.
In blood and stool samples collected at baseline and at follow-up visits, we will measure these plasma proteins by luminex.
Measured: 1 year, 6 months, 3 months
Change in disease severity in FMT- versus placebo-treated patients.
The disease severity will be measured with Model for Endstage Liver Disease (MELD) (range 6-40). A high score reflects poor prognosis.
Measured: 3 months, 6 months, 1 year.
Change in disease severity in FMT- versus placebo-treated patients.
The disease severity will be measured with Child-Pugh score (range 5-15). A high score reflects poor prognosis.
Measured: 3 months, 6 months, 1 year.
Change in disease severity in FMT- versus placebo-treated patients.
The disease severity will be measured with CliF-C Acute decompensation scores (range 0-18). A high score reflects poor prognosis.
Measured: 3 months, 6 months, 1 year.
Change in metabolic liver function in FMT- versus placebo-treated patients.
The metabolic liver function will be measured by the aminopyrine breath test
Measured: 3 months, 6 months, 1 year.
Change in liver stiffness in FMT- versus placebo-treated patients.
Liver stiffness will be measured by liver elastography.
Measured: 3 months, 6 months, 1 year.
Change in the Liver Frailty Index in FMT- versus placebo-treated patients.
The Liver Frailty index (grip strength, chair stands, and balance testing) will be calculated and the index will be compared between the treatment groups. A higher LFI indicates more frailty.
Measured: 3 months, 6 months, 1 year.
Change in body composition in FMT- versus placebo-treated patients.
Body composition will be measured by bioimpedance.
Measured: 3 months, 6 months, 1 year.
Change in cognitive function as measured by continuous reaction time in FMT- versus placebo-treated patients.
The cognitive function will be measured with continuous reaction time.
Measured: 3 months, 6 months, 1 year.
Change in cognitive function in FMT- versus placebo-treated patients.
The cognitive function will be measured with the portosystemic encephalopathy syndrome test.
Measured: 3 months, 6 months, 1 year.
Change in quality adjusted life years (QALY´s) to evalute health care related costs in FMT- versus placebo-treated patients
By using the quality-of-life questionnaire (EQ-5D-5L) a single index will be calculated and used to calculate QALY's.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start1 Jul 2021
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Aalborg University Hospital, Odense University Hospital, Hvidovre University Hospital, Aalborg University, Esbjerg Hospital - University Hospital of Southern Denmark, Sjælland University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932577
- Sponsor's protocol ID
- 1-10-72-302-20
- Acronym
- CHiFT
- Status last verified
- Dec 2024
- First submitted
- 26 May 2021
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stoy S, Eriksen LL, Lauszus JS, Damsholt S, Baunwall SMD, Erikstrup C, Vilstrup H, Jepsen P, Hvas C, Thomsen KL. Cirrhosis and Faecal microbiota Transplantation (ChiFT) protocol: a Danish multicentre, randomised, placebo-controlled trial in patients with decompensated liver cirrhosis. BMJ Open. 2025 Feb 12;15(2):e091078. doi: 10.1136/bmjopen-2024-091078.
PubMed 39938959
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faecal Microbiota Transplantation to Prevent Complications, Progression and Mortality of Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT04932577
- Acronym / sponsor ID
- CHiFT / 1-10-72-302-20
- Conditions
- Liver Cirrhosis
- Keywords
- Hepatic encephalopathy, Ascites, Gastrointestinal bleeding, Spontaneous bacterial peritonitis, Hepatorenal syndrome, Alcoholic hepatitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Aalborg University Hospital, Odense University Hospital, Hvidovre University Hospital, Aalborg University, Esbjerg Hospital - University Hospital of Southern Denmark, Sjælland University Hospital
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 21 Jun 2021 (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.
The purpose is to investigate the effect of faecal microbiota transplantation (FMT) on complications, progression, and mortality of patients with liver cirrhosis. Further, the investigators want to examine the impact of FMT on the gut microbiota, gut barrier function, systemic inflammation, and immune function.
Detailed description
Patients with liver disease have a disturbed gut microbiota. This is often associated with disease progression and development of complications, so-called episodes of decompensation. In this trial, we will change the microbiota of these patients by transferring a healthy microbiota through faeces from a healthy donor, a procedure known as faecal microbiota transplantation (FMT). We will examine the effect of FMT on the prognosis and disease progression of the patients. Further, we will examine the mechanistic effects of FMT. We will at random divide 220 patients admitted with decompensation of liver cirrhosis evenly into two groups. One group will receive FMT and the other group will receive placebo. After the treatment, we will follow the patients for one year and examine disease progression as well as changes in their gut microbiota, gut barrier, and immune function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Faecal microbiota transplantation | Experimental | Biological: Faecal microbiota transplantationThe patients will receive three applications of FMT consisting of 50 g cryopreserved, homogenized faeces from healthy donors. The faecal material will be dispensed into double-coated, acid-resistant enterocapsules or cryobags. Faeces will be screened according to international guidelines. |
| Placebo | Placebo comparator | Biological: PlaceboThe placebo products is produced from a suspension of glycerol, saline and food colouring and cannot be distinguished from the active FMT products. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-75 years
- Liver cirrhosis with Child-Pugh ≤ 12
- Acute decompensation requiring intervention (ascites, gastrointestinal bleeding, infections leading to progressive liver failure, overthepatic encephalopathy, alcoholic hepatitis)
Key exclusion criteria (9 listed)
- More than one organ failure defined by CLIF-SOFA score
- Untreated malignancy apart from non-melanoma skin cancer
- Untreated viral hepatitis
- HIV
- Inflammatory bowel disease
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 |
|---|---|---|
| Faecal microbiota transplantationAlso: FMTAll participant will receive three applications of either FMT or placebo and afterwards followed for 1 year. | Biological | Faecal microbiota transplantation |
| PlaceboPlacebo | Biological | Placebo |
Primary outcome
Time to death or new episode of acute decompensation requiring intervention in FMT versus placebo-treated patients.
Time frame: 1 year
Using data from the patient journals, we will be able to examine the exact time to event in each of the patients. To compare the two groups, hazard ratios will be calculated.
16 secondary outcomes
Time to death or new episode of acute decompensation requiring intervention in FMT versus placebo-treated patients at 3 months and 6 months of follow-up.
Time frame: 3 months, 6 months
Number of new decompensations and deaths during follow-up in the FMT versus the placebo-treated patients.
Time frame: 1 year
Time to death in FMT versus placebo-treated patients. -treated patients at 3 months and 6 months of follow-up.
Time frame: 1 year, 6 months, 3 months
Change in gut microbiota beta-diversity (Bray-Curtis index) during one year in FMT versus placebo-treated patients by shotgun metagenomic sequencing.
Time frame: 1 year, 6 months, 3 months
Change in plasma concentration of gut translocation markers; lipopolysaccharide binding protein, soluble CD14, fatty acid binding protein 1 during one year in FMT versus placebo-treated patients by ELISA.
Time frame: 1 year, 6 months, 3 months
Change in plasma and stool concentration of pro- and antiinflammatory cytokines; IL-6, IL-1beta, TNF-alpha, IL-8, IL-10 in response to the intervention by luminex.
Time frame: 1 year, 6 months, 3 months
Change in disease severity in FMT- versus placebo-treated patients.
Time frame: 3 months, 6 months, 1 year.
Change in disease severity in FMT- versus placebo-treated patients.
Time frame: 3 months, 6 months, 1 year.
Change in disease severity in FMT- versus placebo-treated patients.
Time frame: 3 months, 6 months, 1 year.
Change in metabolic liver function in FMT- versus placebo-treated patients.
Time frame: 3 months, 6 months, 1 year.
Change in liver stiffness in FMT- versus placebo-treated patients.
Time frame: 3 months, 6 months, 1 year.
Change in the Liver Frailty Index in FMT- versus placebo-treated patients.
Time frame: 3 months, 6 months, 1 year.
Change in body composition in FMT- versus placebo-treated patients.
Time frame: 3 months, 6 months, 1 year.
Change in cognitive function as measured by continuous reaction time in FMT- versus placebo-treated patients.
Time frame: 3 months, 6 months, 1 year.
Change in cognitive function in FMT- versus placebo-treated patients.
Time frame: 3 months, 6 months, 1 year.
Change in quality adjusted life years (QALY´s) to evalute health care related costs in FMT- versus placebo-treated patients
Time frame: 1 year
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 24 Jan 2025.
- Derived from this study: PubMed 39938959Stoy S, Eriksen LL, Lauszus JS, Damsholt S, Baunwall SMD, Erikstrup C, Vilstrup H, Jepsen P, Hvas C, Thomsen KL. Cirrhosis and Faecal microbiota Transplantation (ChiFT) protocol: a Danish multicentre, randomised, placebo-controlled trial in patients with decompensated liver cirrhosis. BMJ Open. 2025 Feb 12;15(2):e091078. doi: 10.1136/bmjopen-2024-091078.
- Individual participant dataSharing planned: No
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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 Phase 2/3 study testing Faecal microbiota transplantation in people with Liver Cirrhosis, run by University of Aarhus at 1 site in Denmark.
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 9 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 24 Jan 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 Denmark. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Karen Louise Thomsen, PhD (+4526949260, karethom@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to death or new episode of acute decompensation requiring intervention in FMT versus placebo-treated patients. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04932577, which also lists 1 linked publication.
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 24 Jan 2025.