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NCT Number: NCT04932577

Faecal Microbiota Transplantation for 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.

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Key information

Conditions

Liver Cirrhosis Alcohol-Induced Disorders Alcohol-Related Disorders Ascites Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Chemically-Induced Disorders Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosis Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Hepatic Encephalopathy Hepatic Insufficiency Hepatitis Hepatitis, Alcoholic Hepatorenal Syndrome Kidney Diseases Liver Diseases Liver Diseases, Alcoholic Liver Failure Male Urogenital Diseases Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Substance-Related Disorders Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Hepatology and Gastroenterology, Aarhus University Hospital

Aarhus, 8200, Denmark

Location status: Recruiting

Location contact

Karen Louise Thomsen, PhD

CONTACT

[email protected]

+4526949260

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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
  • Clostridioides Difficile infection
  • Pregnancy
  • Unable to participate based on medical judgement

Treatment and study plan

Faecal microbiota transplantation

Biological

All participant will receive three applications of either FMT or placebo and afterwards followed for 1 year.

Other names: FMT

Placebo

Biological

Placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. Number of new decompensations and deaths during follow-up in the FMT versus the placebo-treated patients.

    Time frame: 1 year

    Incidence rates will be compared between the groups.

  3. 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

    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.

  4. 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

    In stool and saliva samples collected before and at 5 time points following the intervention, we will measure the gut microbiota composition.

  5. 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

    In blood samples collected at baseline and at follow-up visits, we will measure these plasma proteins by ELISA.

  6. 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

    In blood and stool samples collected at baseline and at follow-up visits, we will measure these plasma proteins by luminex.

  7. Change in disease severity in FMT- versus placebo-treated patients.

    Time frame: 3 months, 6 months, 1 year.

    The disease severity will be measured with Model for Endstage Liver Disease (MELD) (range 6-40). A high score reflects poor prognosis.

  8. Change in disease severity in FMT- versus placebo-treated patients.

    Time frame: 3 months, 6 months, 1 year.

    The disease severity will be measured with Child-Pugh score (range 5-15). A high score reflects poor prognosis.

  9. Change in disease severity in FMT- versus placebo-treated patients.

    Time frame: 3 months, 6 months, 1 year.

    The disease severity will be measured with CliF-C Acute decompensation scores (range 0-18). A high score reflects poor prognosis.

  10. Change in metabolic liver function in FMT- versus placebo-treated patients.

    Time frame: 3 months, 6 months, 1 year.

    The metabolic liver function will be measured by the aminopyrine breath test

  11. Change in liver stiffness in FMT- versus placebo-treated patients.

    Time frame: 3 months, 6 months, 1 year.

    Liver stiffness will be measured by liver elastography.

  12. Change in the Liver Frailty Index in FMT- versus placebo-treated patients.

    Time frame: 3 months, 6 months, 1 year.

    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.

  13. Change in body composition in FMT- versus placebo-treated patients.

    Time frame: 3 months, 6 months, 1 year.

    Body composition will be measured by bioimpedance.

  14. Change in cognitive function as measured by continuous reaction time in FMT- versus placebo-treated patients.

    Time frame: 3 months, 6 months, 1 year.

    The cognitive function will be measured with continuous reaction time.

  15. Change in cognitive function in FMT- versus placebo-treated patients.

    Time frame: 3 months, 6 months, 1 year.

    The cognitive function will be measured with the portosystemic encephalopathy syndrome test.

  16. Change in quality adjusted life years (QALY´s) to evalute health care related costs in FMT- versus placebo-treated patients

    Time frame: 1 year

    By using the quality-of-life questionnaire (EQ-5D-5L) a single index will be calculated and used to calculate QALY's.

Study contacts

Contact information is provided by the study sponsor or research team.

Karen Louise Thomsen, PhD

CONTACT

[email protected]

+4526949260

Sidsel Støy, PhD

CONTACT

[email protected]

+4561664565

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aalborg University
  • Aalborg University Hospital
  • Aarhus University Hospital
  • Esbjerg Hospital - University Hospital of Southern Denmark
  • Hvidovre University Hospital
  • Odense University Hospital
  • Sjælland University Hospital

Registry information

Official study title

Faecal Microbiota Transplantation to Prevent Complications, Progression and Mortality of Liver Cirrhosis

Acronym: CHiFT

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Jun 21, 2021
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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