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Microbiota Transplant

Fecal Microbiota Transplant for Hepatic Encephalopathy

Phase 2

Waitlist Available

Led By Raymond T Chung, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before the first administration of fmt (day 0) and one week after the last administration of fmt (day 28)

Awards & highlights

Study Summary

This trial is testing whether transplanting bacteria from the colon of a healthy person into the colon of a patient with advanced liver disease, who is experiencing confusion due to a condition called hepatic encephalopathy, will help to improve the patient's neurological function.

Who is the study for?

This trial is for patients with advanced liver disease who've had at least one episode of hepatic encephalopathy (confusion due to liver problems) but are stable on current treatments. They must not have certain other health issues, recent drug or alcohol use, or be expecting a liver transplant soon.Check my eligibility

What is being tested?

The study tests if swallowing capsules containing healthy stool bacteria can improve brain function in liver disease patients compared to placebo capsules. It's a randomized controlled trial, meaning participants are randomly assigned to receive either the real treatment or a placebo.See study design

What are the potential side effects?

Potential side effects may include digestive discomfort or infection since fecal microbiota transplant involves introducing new bacteria into the body. However, specific side effects will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before the first administration of fmt (day 0) and one week after the last administration of fmt (day 28)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before the first administration of fmt (day 0) and one week after the last administration of fmt (day 28)

This trial's timeline: 3 weeks for screening, Varies for treatment, and before the first administration of fmt (day 0) and one week after the last administration of fmt (day 28) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Psychometric Hepatic Encephalopathy Score (PHES)

Secondary outcome measures

36-Item Short Form Health Survey (SF-36)

Adverse events

Ammonia

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Fecal Microbiota Transplant (FMT) oral capsulesExperimental Treatment1 Intervention

Subjects will receive 15 oral capsules of FMT on days 1, 2, 7, 14, and 21.

Group II: Placebo capsulesPlacebo Group1 Intervention

Subjects will receive placebo capsules on the same schedule as the experimental arm (days 1, 2, 7, 14, and 21).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,325 Total Patients Enrolled

Center for Microbiome Informatics and TherapeuticsUNKNOWN

Raymond T Chung, MDPrincipal InvestigatorMassachusetts General Hospital

6 Previous Clinical Trials

69 Total Patients Enrolled

Media Library

Encephalopathy Research Study Groups: Placebo capsules, Fecal Microbiota Transplant (FMT) oral capsules

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include participants over 20 years of age?

"This clinical trial necessitates that qualified participants must be aged 18-75. For those younger than 18, there are 64 studies available, while 84 trials are open to individuals over 65 years old."

Answered by AI

Is there still capacity for participants to join this trial?

"Data posted on clinicaltrials.gov reveals that this medical trial, which was first introduced in April of 2018 and last edited on March 4th 2022, is no longer recruiting patients. Nonetheless, 139 other trials are actively enrolling participants at the moment."

Answered by AI

Has the FDA granted its official sanction to Fecal Microbiota Transplant (FMT) in pill form?

"Due to the Phase 2 nature of this trial, our team at Power has assigned Fecal Microbiota Transplant (FMT) oral capsules a safety rating of two out of three. This denotes that there is slight evidence for safety but no data supporting efficacy yet."

Answered by AI

Am I eligible to join this clinical trial?

"To be eligible for this experiment, participants must possess hepatic coma and their age should fall between 18 and 75. The investigation is looking to enroll a total of 30 individuals."

Answered by AI

Recent research and studies

HepatologyJournal

Fecal Microbiota Transplant from a Rational Stool Donor Improves Hepatic Encephalopathy: A Randomized Clinical Trial

Bajaj, Jasmohan S., Zain Kassam, Andrew Fagan, Edith A. Gavis, Eric Liu, I. Jane Cox, Raffi Kheradman, et al.. 2017. “Fecal Microbiota Transplant from a Rational Stool Donor Improves Hepatic Encephalopathy: A Randomized Clinical Trial”. Hepatology. Wiley. doi:10.1002/hep.29306.

clostridium DifficileJournal

Effect of Oral Capsule– Vs Colonoscopy-delivered Fecal Microbiota Transplantation on Recurrent <i>clostridium Difficile</i> Infection

Kao, Dina, Brandi Roach, Marisela Silva, Paul Beck, Kevin Rioux, Gilaad G. Kaplan, Hsiu-Ju Chang, et al.. 2017. “Effect of Oral Capsule– Vs Colonoscopy-delivered Fecal Microbiota Transplantation on Recurrent clostridium Difficile Infection”. Jama. American Medical Association (AMA). doi:10.1001/jama.2017.17077.

BMC MedicineJournal

Oral, Frozen Fecal Microbiota Transplant (FMT) Capsules for Recurrent Clostridium Difficile Infection

Youngster, Ilan, Jasmin Mahabamunuge, Hannah K. Systrom, Jenny Sauk, Hamed Khalili, Joanne Levin, Jess L. Kaplan, and Elizabeth L. Hohmann. 2016. “Oral, Frozen Fecal Microbiota Transplant (FMT) Capsules for Recurrent Clostridium Difficile Infection”. BMC Medicine. Springer Science and Business Media LLC. doi:10.1186/s12916-016-0680-9.

clostridium DifficileJournal