None listed
Conditions
Brief summary
The gut microbiome (complete collection of microorganisms) of Crohn's disease patients has been found to significantly differ in diversity and composition to the gut microbiomes of healthy individuals. This microbial dysbiosis is thought to play a significant role in the pathogenesis of Crohn's disease by switching on the host's inflammatory immune response, causing wide spread intestinal inflammation. Current treatments for Crohn's disease focus on dampening down the inflammation and are often ineffective or associated with unpleasant side effects. An alternative treatment approach is to target the gut microbiome directly to try and prevent the inflammation from occurring in the first place. Gut microbiome transfer (GMT) is a procedure that involves isolating the bacterial community from the stool of a healthy individual and administering it to a patient with gut dysbiosis. This form of therapy has proven overwhelmingly effective at resolving gastrointestinal infections (>92% cure rates) and has been shown to be a promising treatment for Crohn's disease based on small scale pilot studies (58-87% clinical response rates). Our study aims to build on these findings by testing a capsule-based, multi-dose GMT treatment protocol. We will perform a small-scale randomized control trial on 20 adult male Crohn's disease patients which will compare the effectiveness of our protocol against a placebo control. We hypothesize that GMT will be well-tolerated and lead to significant improvements in patient’s clinical disease and symptom scores, and health-related quality of life.
Interventions
Gut Microbiome Transfer (GMT) capsules - a 650 ul aliquot of pooled bacteria (resuspended in 0.9% saline solution containing 15% glycerol) that was isolated from the stool of 4 healthy, clinically screened donors will be double encapsulated into size 0 and size 00 DRcpasTM capsules.
Placebo capsules - a 650 ul aliquot of 0.9% saline solution containing 15% glycerol will be double encapsulated into size 0 and size 00 DRcpasTM capsules.
Participants will be blindly randomized to receive either
Gut Microbiome Transfer (GMT) capsules - a 650 ul aliquot of pooled bacteria (resuspended in 0.9% saline solution containing 15% glycerol) that was isolated from the stool of 4 healthy, clinically screened donors will be double encapsulated into size 0 and size 00 DRcpasTM capsules. Placebo capsules - a 650 ul aliquot of 0.9% saline solution containing 15% glycerol will be double encapsulated into size 0 and size 00 DRcpasTM capsules. Participants will be blindly randomized to receive either the intervention (GMT capsules) or the placebo (saline capsules). These capsules will be given to participants to swallow with water on three occasions under direct supervision by research staff Dose 1 - baseline: 16 capsules Dose 2 - week 2: 14 capsules Dose 3 - week 4: 14 capsules
Sponsors
Associate Professor Justin O'Sullivan
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Patients - male - 20-50 years old - mild to moderate Crohn's disease (HBI 5-16) Donors - male - 20-50 years old - healthy - BMI 18.5 - 24.9 kg/m2
Exclusion criteria
Donor exclusion criteria: - Chronic disease - Gastrointestinal disease (including irritable bowel syndrome, coeliac and inflammatory bowel disease) - Any transmissible viral, bacterial, or protozoan pathogens - Current or past history of malignancy (including gastrointestinal cancer or polyposis) - Acute substance abuse (including tobacco, >7 standard alcoholic units/week, recreational drugs) - Use of probiotics or antibiotics in the past 6 months - Atopic diseases (e.g. asthma, eczema) - Chronic pain or chronic fatigue syndromes - Overseas travel in previous three months - Metabolic syndrome - First-degree relative with type 2 diabetes mellitus Patient exclusion criteria - Bowel complications (including abscess, phlegmon, stricture, obstruction, perforation, fistula, or infection) - Requiring or expected to require surgery - Major abdominal surgery in the past 3 months - Use of antibiotics or probiotics in the past 3 months - Acute substance abuse (including tobacco, >7 standard alcoholic units/week, recreational drugs) - Chronic hepatitis B, C, or HIV infection - Diabetes mellitus, cancer, or systemic lupus - Food allergies - Allergy to Biscodyl tablets or Glycoprep - Swallowing dysfunction or esophageal dysmotility
Outcome results
None listed