NCT02636647

Fecal Transplant in Recurrent Hepatic Encephalopathy

Safety and Tolerability of Fecal Microbiota Transplantation in Cirrhosis and Hepatic Encephalopathy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Jasmohan Bajaj · Federal
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Randomized, open-label safety, tolerability study with exploratory endpoints and pathophysiological evaluation of the FMT Two groups of outpatients with cirrhosis will be randomized using random sequence generator into no-treatment and FMT groups.

Detailed description

Group 1 (FMT group) will undergo the following procedures Pre-FMT preparation: We will obtain written informed consent per the IRB guidelines. After the patients are consented and are eligible, we will perform a detailed medical history and physical exam at day 0. We will also perform cognitive testing. As in prior studies, we will prescribe patients an antibiotic regimen. Drawing from ecological principles of microbial niche environments and data from recurrent Clostridium difficile infection, pre-treatment antibiotics are likely to increase the probability of disrupting the hosts intrinsic microbiota and creating an opportunity for a 'healthy' microbiota from the FMT to engraft. After antibiotics and on the day of FMT: At day 5, we will re-evaluate patients with a directed interval history and focused physical exam as needed. After ensuring that they are still candidates according to the inclusion/exclusion criteria, we will collect stool, urine and blood again for pre-FMT evaluation and urine for pregnancy tests from eligible women. Cognitive testing will be performed again. Preparation and handling of stool for FMT infusion Standard protocol for handling bio-hazardous material will be employed in order to avoid contamination and risk to healthcare handlers. Sterile microbiological technique will be employed during material transfer peri-procedure. At that point we will provide the fecal material using universal precautions to a standard retention enema bag. The procedure will be completed by a trained Registered Nurse, Nurse practitioner, or physician in an outpatient clinic, endoscopy recovery area, or standard endoscopy unit. The following will be recorded in all FMTs * Dose * Unit ID/Lot# of each treatment * Expiration Date * Storage Condition * FMT retention time (in minutes) Number of FMT: One administration Duration of Follow-up after FMT: 5 months Follow-up after FMT: We will see the patient in clinic the day following FMT (day 6 or FMT+1), day 12 (FMT+7), day 20 (FMT+15), and day 35 (FMT+30), at which point a detailed history regarding abdominal symptoms, evaluation of infectious complications, hospitalizations or complications of cirrhosis. Visits on day 6, day 12 and day 35 will be purely safety associated while, on the day 20 visit, we will repeat the pathophysiological studies. In order to ensure that we have enough samples, in case patients are not able to return at day 20, we will also collect all samples at day 12, but will only analyze them in case the day 20 visit does not occur. These visits, apart from the visit after FMT, will be ±2 days for patient convenience. At 5 months post-FMT, subjects will be followed up with a phone call to evaluate potential SAEs, new onset of transmitted infections, new onset or significant worsening of chronic medical conditions or suspected unexpected serious adverse reactions that have occurred in between 35 days and 5 months for reporting purposes. Samples collected at baseline (before FMT), after antibiotics and at day 15 will be: 1. Stool 2. Blood 3. Urine Group 2: No treatment arm The group 2 will undergo all sample collections, follow-up and cognitive testing as in group 1 but without the 5-day antibiotic therapy or the FMT. In addition, we will also not perform the sample collection that is done after 5 days of antibiotics in this group since no reasonable change in microbiota are expected over 5 days without antibiotics. The follow-up of this group will be same as that of the FMT group.

Conditions

• Hepatic Encephalopathy
• Cirrhosis

Interventions

Type	Name	Description
BIOLOGICAL	Fecal transplant

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2015-12-22
• Last updated: 2022-07-05

Locations

1 site across 1 country: United States