Fecal Microbiome Transplantation in Cirrhosis: Trial in Patients With Decompensated Cirrhosis

NCT06533852 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 2023-509151-13-00
• Study Type: interventional
• Target: 190
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase III, multicenter, double-blind, placebo-controlled, randomized clinical trial to evaluate the safety and efficacy of Fecal Microbiota Transplantation (FMT) from healthy subjects to patients with decompensated cirrhosis.

Conditions

Decompensated Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Efficacy of treatment in halting the progression of decompensated cirrhosis.

  Assessed by time to first decompensation event (acute kidney injury (AKI), ascites, bacterial infection, gastrointestinal bleeding, HE).

  Screening to month 12.

Secondary Outcomes (26)

• Time to transplant-free survival

  At month 1, month 3, month 6 and month 12

• Mortality rates

  At month 1, month 3, month 6 and month 12

• Rate of patients developing/ worsening individual complications of cirrhosis.

  At baseline, month 1, month 3, month 6 and month 12.

• Frequency of hospital admissions due to complications of cirrhosis.

  At baseline, 1 month, 3 months, 6 months and 12 months.

• Development of acute-on-chronic liver failure (ACLF)

  At baseline, 1 month, 3 months, 6 months and 12 months.

Study Arms (2)

Fecal Microbiome Transplantation (FMT)

EXPERIMENTAL

A first dose of 24 capsules of FMT at baseline and a second dose of 24 capsules of FMT at 3 months. Each dose (24 capsules) contains approximately 50g of stool.

Drug: Fecal Microbiome Transplantation (FMT)

FMT Placebo

PLACEBO COMPARATOR

A first dose of 24 capsules of FMT placebo at baseline and a second dose of 24 capsules of FMT placebo at 3 months. Each dose (24 capsules) contains in total 6 g of microcrystalline cellulose or equivalent.

Other: FMT Placebo

Interventions

Fecal Microbiome Transplantation (FMT) DRUG

Two doses: First dose: 24 capsules of FMT at baseline. Second dose: 24 capsules of FMT at 3 months.

Fecal Microbiome Transplantation (FMT)

FMT Placebo OTHER

Two doses: First dose: 24 capsules of FMT placebo at baseline. Second dose: 24 capsules of FMT placebo at 3 months.

FMT Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old.
• Cirrhosis defined by standard clinical criteria, ultrasonographic findings and/or histology. Cirrhosis of any etiology may be included except from patients with cirrhosis due to autoimmune hepatitis, and patients with cirrhosis due to cholestatic liver disease can only be included in the study if they present clinical decompensation of cirrhosis (i.e. ascites).
• Child-Pugh B or C patients (7- up to 12 points).

You may not qualify if:

• Previous history of gastrointestinal surgery or colorectal cancer.
• Patients with previous history of intestinal obstruction or those who are at increased risk of this complication.
• Active Clostridium Difficile infection.
• Patients on treatment with non-selective beta-blockers for \<3 month or without stable doses.
• Patients on treatment with any immunosuppressive drugs.
• Patients on antiviral therapy for HCV or those who have received it within the last 12 months.
• Patients on antiviral therapy for HBV therapy for \< 12 months.
• Patients with hepatocellular carcinoma, except for patients with early HCC (BCLC-0 or BCLC-A) or patients with previous history of HCC and absence of recurrence 2 years after treatment.
• Patients admitted to the hospital for acute decompensation of the disease. These patients could be included after discharged as long as they do not present any of the following events:
• Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the New-Haven classification.
• Patients with ACLF according to the criteria published by Moreau et al. (Appendix 1).
• Severe alcoholic hepatitis requiring corticosteroid therapy (MELD \> 20) in the last 6 months.
• Patients with active alcohol consumption of more than 21 units per week.
• HIV infection.
• Patients with a history of significant extra hepatic disease with impaired short-term prognosis, including congestive heart failure New York Heart Association Grade III/IV, COPD GOLD \>2, chronic kidney disease with serum creatinine \>2mg/dL or under renal replacement therapy.

Sponsors & Collaborators

• Consorcio Centro de Investigación Biomédica en Red (CIBER): lead

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Central Study Contacts

Eva Bonfill

CONTACT

+34932275400; BONFILL@recerca.clinic.cat

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: August 1, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: August 1, 2024

Record last verified: 2024-07