Oral Fecal Transplant in Cirrhosis

NCT03152188 | Completed Phase 1 FDA Drug

• 2 other identifiers: HM200093921R21TR002024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the safety and tolerability of oral fecal transplant in patients with cirrhosis and hepatic encephalopathy

Conditions

Hepatic Encephalopathy; Cirrhosis, Liver

Keywords

Hepatic Encephalopathy; Cirrhosis; Liver; Openbiome; FMT Capsule; Placebo

Outcome Measures

Primary Outcomes (1)

• Serious Adverse events related to FMT

  Safety

  5 months

Secondary Outcomes (6)

• Frequency, severity and relatedness of solicited and unsolicited AEs

  5 months

• Occurrence of new potentially transmitted infections in the FMT group

  5 months

• Occurrence of new onset or significant worsening of chronic medical conditions post-FMT

  5 months

• changes in microbiota composition of the stool, duodenal and sigmoid colonic mucosa after oral FMT compared to pre-FMT baseline and donor compared to placebo post-FMT

  30 days

• mucosal defenses by studying antimicrobial peptides, inflammatory cytokine expression and barrier protein expression compared to pre-FMT baseline and compared to placebo

  30 days

Study Arms (2)

FMT

EXPERIMENTAL

Fecal Microbiota Transplantation (FMT) capsules

Drug: FMT

Placebo

PLACEBO COMPARATOR

Placebo capsules

Other: Placebo

Interventions

FMT DRUG

Fifteen FMT Openbiome capsules administered at the same time

FMT

Placebo OTHER

Fifteen placebo capsules administered at the same time

Placebo

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Cirrhosis diagnosed by either of the following in a patient with chronic liver disease (a) Liver Biopsy (b) Radiologic evidence of varices, cirrhosis or portal hypertension (c) Laboratory evidence of platelet count \<100,000 or AST/ALT ratio\>1 (d) Endoscopic evidence of varices or portal gastropathy
• At least two HE episodes, one within the last year but not within the last month (patient can be on lactulose and rifaximin)
• Able to give written, informed consent (mini-mental status exam\>25 at the time of consenting)

You may not qualify if:

• Disease-related: (1) MELD score\>17 (2) WBC count\<1000 (3) TIPS, non-elective hospitalization or HE within last month (4) on dialysis (5) known untreated, in-situ luminal GI cancers (6) chronic intrinsic GI diseases (ulcerative colitis, Crohn's disease or microscopic colitis, eosinophilic gastroenteritis and celiac disease) Endoscopy-related: (1) Platelet count\<50,000 (2) adverse reactions to sedation (3) lack of driver or other contra-indications Safety-related: (1) Dysphagia (2) History of aspiration, gastroparesis, intestinal obstruction (3) Ongoing absorbable antibiotic use (4) Severe anaphylactic food allergy (5) allergy to ingredients Generally Recognized As Safe in the G3 capsules (glycerol, sodium chloride, hypromellose, gellan gum, titanium dioxide, theobroma oil) (6) Adverse event attributable to prior FMT (7) ASA Class IV or V (8) Pregnant or nursing patients (9) acute illness or fever on the day of planned FMT

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• OpenBiome: collaborator
• Medical College of Wisconsin: collaborator
• Hunter Holmes McGuire VA Medical Center: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (2)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (2)

• Bajaj JS, Salzman N, Acharya C, Takei H, Kakiyama G, Fagan A, White MB, Gavis EA, Holtz ML, Hayward M, Nittono H, Hylemon PB, Cox IJ, Williams R, Taylor-Robinson SD, Sterling RK, Matherly SC, Fuchs M, Lee H, Puri P, Stravitz RT, Sanyal AJ, Ajayi L, Le Guennec A, Atkinson RA, Siddiqui MS, Luketic V, Pandak WM, Sikaroodi M, Gillevet PM. Microbial functional change is linked with clinical outcomes after capsular fecal transplant in cirrhosis. JCI Insight. 2019 Dec 19;4(24):e133410. doi: 10.1172/jci.insight.133410.

  PMID: 31751317 DERIVED

• Bajaj JS, Salzman NH, Acharya C, Sterling RK, White MB, Gavis EA, Fagan A, Hayward M, Holtz ML, Matherly S, Lee H, Osman M, Siddiqui MS, Fuchs M, Puri P, Sikaroodi M, Gillevet PM. Fecal Microbial Transplant Capsules Are Safe in Hepatic Encephalopathy: A Phase 1, Randomized, Placebo-Controlled Trial. Hepatology. 2019 Nov;70(5):1690-1703. doi: 10.1002/hep.30690. Epub 2019 Jun 18.

  PMID: 31038755 DERIVED

MeSH Terms

Conditions

Hepatic Encephalopathy; Liver Cirrhosis; Fibrosis

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jasmohan Bajaj, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Single-blind study in which subjects will not be aware whether they will be on placebo or FMT capsulres
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Placebo-controlled single-blind randomized trial

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 12, 2017
• Study Start: June 12, 2017
• Primary Completion: November 12, 2018
• Study Completion: November 12, 2018
• Last Updated: May 19, 2021

Record last verified: 2021-05

Locations

US (2)