Fecal Microbiota Transplantation in Decompensated Cirrhosis

NCT04842539 | Completed DMC

• 1 other identifier: INT/IEC2018/2076
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

End-stage liver disease; Stool therapy; Microbiota; Related stool donor; Prognostic scores; Complications; Ammonia; Cytokines; Outcomes

Outcome Measures

Primary Outcomes (1)

• Survival

  180 days

  180 day

Secondary Outcomes (7)

• Change in Child Turcotte Pugh Score

  180 days

• Change in MELD score

  180 days

• Change in MELD Na score

  180 days

• Change in ammonia level

  28 days

• Change in Interleukin level

  28 days

Study Arms (2)

FMT Arm

EXPERIMENTAL

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

Other: Fecal Microbiota Transplantation

Standard of care (SOC) Arm

OTHER

Standard of care treatment with nutritional supplementation and other supportive care

Other: Standard of care

Interventions

Fecal Microbiota Transplantation 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.

FMT Arm

Standard of care OTHER

Nutritional supplementation and other supportive measures as per standard guidelines

Standard of care (SOC) Arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Post Graduate Institute of Medical Education and Research

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Liver Cirrhosis; End Stage Liver Disease

Interventions

Fecal Microbiota Transplantation; Standard of Care

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Hepatology

Study Record Dates

• First Submitted: April 3, 2021
• First Posted: April 13, 2021
• Study Start: August 1, 2018
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: April 13, 2021

Record last verified: 2021-04

Locations

IN (1)