Lyophilised Orally Administered Faecal Microbiota Transplantation in the Management of Ulcerative Colitis (LOTUS) Study – a Double-Blind Randomised Controlled Trial

Principal Investigator – Professor Rupert Leong

The University of Sydney, Concord Clinical School

Inflammatory bowel disease (IBD) is a chronic disabling gastrointestinal condition thought to be caused by disturbances in the interaction between our immune system and the microorganisms in our gastrointestinal tract. Current therapies for IBD are expensive and rely on suppressing the immune system which is associated with significant side effects, increased risk of infections and certain cancers. Even if initially effective, subsequent loss of response to these therapies is common.

Faecal microbial transplantation (FMT) is the infusion of faecal material (and associated microorganisms) derived from a healthy individual (donor) to a diseased individual. It aims to correct the imbalance in the recipient’s gut microbiome by replacing it with microbiota from healthy donors. FMT is a promising non-immunosuppressive, non-pharmacological treatment for ulcerative colitis (UC) with studies showing that FMT delivered by colonoscopy followed by regular enema therapy will lead to improvement in active UC. Ongoing therapy with FMT may have the ability to maintain remission in UC, however FMT delivered through colonoscopy or regular enema therapy is not practical in the long term.

FMT in an oral capsule form is the ideal form of therapy and may revolutionise the treatment of UC. We have commenced a controlled trial assessing orally administered FMT given by capsules to treat ulcerative colitis both as an induction therapy as well a maintenance treatment. We believe findings from this trial will advance the field of microbial based treatments in IBD

A Randomised Controlled Trial Studying the Impact of Diet on Inflammation In The Colon

Principal Investigator – Dr Alice Day

The Queen Elizabeth Hospital & Basil Hetzel Institute, South Australia

In this study, participants with mild to moderately active ulcerative colitis are randomised to follow one of two diets for 8 weeks. One diet is the therapeutic sulphide reducing diet and the other a placebo diet.  Participants are required to shop, prepare and cook simple meals following the dietary advice and they will complete a series of assessments at three time points during the study which will measure inflammation in the colon, adherence to the diet and fermentation biomarkers to monitor how food is digested and metabolized by bacteria in the colon. This includes a new, state-of-the-art gas capsule to measure production of gastrointestinal gases in real time.

The project’s hypothesis is that the intervention diet can reduce colonic inflammation by normalizing gastrointestinal transit time and altering fermentation of dietary substrate and associated production of potentially harmful gases by bacteria in the colon.   Undertaking this research will:

• Advance our understanding of the role of diet in the pathogenesis and treatment of ulcerative colitis by providing mechanistic insight into whether dietary substrate and microbial fermentation may be drivers of inflammation;

• May inform a new diet therapy to use as treatment for ulcerative colitis; and

• Will provide people living with this condition practical guidance on how best to eat to control inflammation and improve their food-related quality of life.