Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Aalborg University Hospital | OTHER |
| Odense University Hospital | OTHER |
| Hvidovre University Hospital |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faecal microbiota transplantation | Biological | All participant will receive three applications of either FMT or placebo and afterwards followed for 1 year. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months, 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen Louise Thomsen, PhD | Contact | +4526949260 | karethom@rm.dk | |
| Sidsel Støy, PhD | Contact | +4561664565 | sidsel.stoy@clin.au.dk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hepatology and Gastroenterology, Aarhus University Hospital | Recruiting | Aarhus | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39938959 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D006501 | Hepatic Encephalopathy |
| D001201 | Ascites |
| D006471 | Gastrointestinal Hemorrhage |
| D006530 | Hepatorenal Syndrome |
| D006519 | Hepatitis, Alcoholic |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
| OTHER |
| Aalborg University | OTHER |
| Esbjerg Hospital - University Hospital of Southern Denmark | OTHER |
| Sjælland University Hospital | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Biological | Placebo |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 3 months, 6 months, 1 year. |
| Change in liver stiffness in FMT- versus placebo-treated patients. | Liver stiffness will be measured by liver elastography. | 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. | 3 months, 6 months, 1 year. |
| Change in body composition in FMT- versus placebo-treated patients. | Body composition will be measured by bioimpedance. | 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. | 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. | 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. | 1 year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005767 | Gastrointestinal Diseases |
| D006470 | Hemorrhage |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006505 | Hepatitis |
| D008108 | Liver Diseases, Alcoholic |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |