IMPuLCE (Intestinal Microbiota Product in Liver Cirrhosis and Encephalopathy)
Research type
Research Study
Full title
A Multicentre, Randomised, Double-blind Placebo-controlled, Phase II Study to Evaluate the Safety, Tolerability and Dose of Dried Intestinal Microbiota Medicinal Product, EBX-102 in Liver Cirrhosis Subjects (IMPuLCE)
IRAS ID
1005961
Contact name
Julie Bakobaki
Contact email
Sponsor organisation
EnteroBiotix Limited
ISRCTN Number
ISRCTN11352030
Research summary
The aim of the study is to assess the safety and tolerability of a potential treatment, called EBX-102, for patients with liver cirrhosis and to learn about the effects of EBX-102 on gut microbiota diversity. The main function of the liver is to remove toxins from the body, such as ammonia. In patients with cirrhosis, the build up of ammonia can lead to significant illness which affects the brain function and can lead to irreversible brain damage, coma or death. It has been shown that imbalanced gut microbial function plays a critical role in the development and worsening of cirrhosis. Patients with cirrhosis are also more susceptible to infections, are frequently prescribed antibiotics and have multiple hospitalisations. Current treatments such as lactulose and rifaximin help to eliminate ammonia from the body but there are side effects associated with their use. Medicinal approaches to correcting the gut imbalance are now of high interest to treat chronic liver cirrhosis and prevent the symptoms of raised ammonia levels, that can lead to hepatic encephalopathy (HE). EBX-102 has the potential to improve microbial diversity. EBX-102 capsules contain communities of dried, intestinal microorganisms taken from carefully screened pooled human stool samples. EBX-102 will be given as a single dose soon after randomisation under strict observation and thereafter participants are followed for 12 weeks to assess safety, tolerability and microbiota dynamics. The study is a phase II, multicentre, randomised, double-blind placebo-controlled trial. The study will involve two parts (A and B). At the end of Part A, a Dose Selection Review (DSR) meeting will occur to determine the dose for part B. Safety will be monitored by a Safety Review Team and assessments will include: Documentation of adverse events, blood and urine tests, stool sample tests, ECG, HE assessments and questionnaires.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
22/EM/0259
Date of REC Opinion
21 Feb 2023
REC opinion
Further Information Favourable Opinion