Fecal Microbiota Transplant as Treatment of Hepatic Encephalopathy
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|ClinicalTrials.gov Identifier: NCT03420482|
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : March 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hepatic Encephalopathy||Drug: Fecal Microbiota Transplant (FMT) oral capsules Drug: Placebo oral capsule||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a two part study. The first part is a 10-patient pilot study, used to find 2 stool donors who precipitate the largest improvement in recipient neurological function and microbiome composition. The second part is a 20-patient RCT, where patients will be randomized to FMT or placebo.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Randomization will be performed by the lab producing the FMT and placebo capsules. Participants, providers, investigators and research assistants will be blinded.|
|Official Title:||Fecal Microbiota Transplant as Treatment of Hepatic Encephalopathy|
|Actual Study Start Date :||April 1, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||January 31, 2021|
Experimental: Fecal Microbiota Transplant (FMT) oral capsules
Subjects will receive 15 oral capsules of FMT on days 1, 2, 7, 14, and 21.
Drug: Fecal Microbiota Transplant (FMT) oral capsules
Donors will be healthy individuals, selected through a previously published, rigorous screening process. Elizabeth Hohmann M.D. of MGH has demonstrated the safety and therapeutic efficacy of oral frozen FMT capsules in Clostridium difficile infection, and her lab will produce the capsules for this study.
Placebo Comparator: Placebo capsules
Subjects will receive placebo capsules on the same schedule as the experimental arm (days 1, 2, 7, 14, and 21).
Drug: Placebo oral capsule
Oral placebo capsules filled with glycerol and cocoa powder. These capsules are identical in appearance to FMT capsules.
- Psychometric Hepatic Encephalopathy Score (PHES) [ Time Frame: Before the first administration of FMT (day 0) and one week after the last administration of FMT (day 28) ]The PHES is a validated assessment tool specifically designed for HE trials to test cognitive and psychomotor processing speed and visuomotor coordination. The PHES is a battery of 5 pencil-paper tests, completed in 15-20 minutes. The primary outcome is the change in PHES score from immediately before FMT to 1 week after the last dose of FMT.
- Adverse events [ Time Frame: Adverse event reporting will take place on day 2, 4, 7, 14, 21, then 1, 4 weeks after the last FMT administration. ]Adverse events will be graded based on CTCAE V.4.03.
- Stroop Test [ Time Frame: Before the first administration of FMT (day 0) and one week after the last administration of FMT (day 28) ]The Stroop Test evaluates psychomotor speed and cognitive flexibility by the interference between recognition reaction time to a colored field and a written color name. A smartphone application software called "EncephalApp Stroop Test" will be used, validated to identify cognitive dysfunction in cirrhosis and screen for covert hepatic encephalopathy.
- 36-Item Short Form Health Survey (SF-36) [ Time Frame: Before the first administration of FMT (day 0) and one week after the last administration of FMT (day 28) ]The SF-36 is a highly utilized quality of life questionnaire. There are 8 health concepts assessed by the survey, which includes physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each of these health concepts is scored on a scale from 0 to 100. 0 is considered the worst outcome and 100 is considered the most favorable health state on each subscale. There will be no total or summed score.
- Ammonia level [ Time Frame: Before the first administration of FMT (day 0) and one week after the last administration of FMT (day 28) ]Ammonia is a serology with a known association with hepatic encephalopathy.
- Microbiome engraftment [ Time Frame: Before the first administration of FMT (day 0), after 3 FMT administrations (day 14), one week after the last administration of FMT (day 28) and 4 weeks after the last administration of FMT. ]Sequence-based microbiome surveys will be carried out using metagenomic sequencing. Computational analyses will investigate donor microbiota colonization by comparing single-nucleotide variants in strain level data between the donor and recipient.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03420482
|Contact: Patricia L Pringle, MDfirstname.lastname@example.org|
|Contact: Jenna Gustafsonemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Massachusetts G Hospital 978-460-0538 firstname.lastname@example.org|
|Principal Investigator:||Raymond T Chung, MD||Massachusetts General Hospital|