Fecal Microbiota Transplantation in Decompensated Cirrhosis

NCT ID: NCT04842539

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2019-11-30

Brief Summary

Cirrhosis of the liver is the culmination point of long-standing chronic liver disease hallmarked by the cardinal features of liver fibrosis and portal hypertension. The prognosis of patients with cirrhosis is punctuated by the onset of complications which denote the stage of decompensation characterized by ascites, hepatic encephalopathy (HE), and variceal bleeding.

Patients with cirrhosis have been demonstrated to have significant changes in their gut microbiota characterized by alteration in the intestinal microbiome (gut dysbiosis) as well as small intestinal bacterial overgrowth (SIBO). Gut dysbiosis has been closely linked to the complications associated with decompensated cirrhosis. Several studies have documented the alteration of gut microbiota in patients with hepatic encephalopathy.

Therapeutic modalities that restore normal gut flora and stabilize the gut liver axis are being extensively studied in the management of cirrhosis and its complications. Antibiotics, probiotics, and long-chain fatty acid supplementation are being evaluated as methods to restore the gut dysbiosis and consequently limit progressive liver damage.

Fecal Microbiota Transplantation (FMT) involves the infusion of intestinal microorganisms by the transfer of stool from a healthy individual into a diseased individual for restoration of normal intestinal flora.The ultimate goal of FMT is to replace aberrant native microbiota with a stable community of donor microorganisms. The treatment is based on the premise that an imbalance in the community of microorganisms residing in the gastrointestinal tract (i.e., dysbiosis) is associated with specific disease states. FMT has been well-established as a treatment modality to stably modify the gut microbiome and has been shown to be safe and efficacious in several disease states resulting from gut dysbiosis.

With this background, a trial is proposed to determine whether an FMT from a healthy donor to a patient with advanced cirrhosis improves overall survival and prognosis.

Conditions

Liver Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FMT Arm

FMT Arm:30 grams stool homogenized with 100 mL normal saline and filtered administered a single time via nasojejunal tube.

Group Type: EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type: OTHER

In the Fecal Microbiota Transplantation procedure 100 ml volume of strained and filtered stool will be delivered through a nasojejunal tube.The recipient patient will be kept nil per oral for at least 4 hours prior to the stool instillation. 100 mL of freshly prepared stool suspension will be given.

Standard of care (SOC) Arm

Standard of care treatment with nutritional supplementation and other supportive care

Group Type: OTHER

Standard of care

Intervention Type: OTHER

Nutritional supplementation and other supportive measures as per standard guidelines

Interventions

Fecal Microbiota Transplantation

In the Fecal Microbiota Transplantation procedure 100 ml volume of strained and filtered stool will be delivered through a nasojejunal tube.The recipient patient will be kept nil per oral for at least 4 hours prior to the stool instillation. 100 mL of freshly prepared stool suspension will be given.

Intervention Type: OTHER

Standard of care

Nutritional supplementation and other supportive measures as per standard guidelines

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Age 18-65 years Decompensated cirrhosis (of any etiology) based on clinical, radiological, or histological criteria Model for end-stage liver disease (MELD scores) between 12-21 were included.

Exclusion Criteria

Ongoing bacterial infection requiring antibiotics Antibiotics/pre-pro biotics within the last 14 days, t Significant alcohol intake in the previous two months, Recent (<14 days) history of spontaneous bacterial peritonitis, HE or variceal bleed, History of substance abuse or psychiatric illness, HIV infection, Pregnant patients, Hepatocellular carcinoma or other known malignancy, t Prior liver transplantation or bariatric surgery, Immunosuppression, Inflammatory bowel disease Celiac disease, History of allergy to food substances

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Radha K Dhiman

Professor of Hepatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Post Graduate Institute of Medical Education and Research

Chandigarh, , India

Countries

India

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

INT/IEC2018/2076

Identifier Type: -

Identifier Source: org_study_id