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Trial registered on ANZCTR


Registration number
ACTRN12618001590257
Ethics application status
Approved
Date submitted
18/09/2018
Date registered
25/09/2018
Date last updated
14/05/2021
Date data sharing statement initially provided
14/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Gut Microbiome Transfer for the Treatment of Crohn’s Disease
Scientific title
Gut Microbiome Transfer for the Treatment of Crohn’s Disease
Secondary ID [1] 296117 0
None
Universal Trial Number (UTN)
U1111-1220-6328
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 309707 0
Inflammatory Bowel Disease 309708 0
Condition category
Condition code
Oral and Gastrointestinal 308513 308513 0 0
Crohn's disease
Oral and Gastrointestinal 308529 308529 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 312457 0
Treatment: Other
Comparator / control treatment
Saline capsules
Control group
Placebo

Outcomes
Primary outcome [1] 307486 0
Change in severity of intestinal inflammation as assessed by endoscopic index score
Timepoint [1] 307486 0
6 weeks post-initial treatment dose [primary timepoint]
6 months post-initial treatment dose [secondary timepoint]
Secondary outcome [1] 352051 0
Change in Crohn's disease symptom severity as assessed by Harvey Bradshaw Index (HBI) score
Timepoint [1] 352051 0
6 weeks post-initial treatment dose
6 months post-initial treatment dose
Secondary outcome [2] 352052 0
Change in health-related quality of life as assessed by the short inflammatory bowel disease questionnaire (SIBDQ)
Timepoint [2] 352052 0
6 weeks post-initial treatment dose
6 months post-initial treatment dose
Secondary outcome [3] 352053 0
Explore any changes to the gut microbiome (diversity, composition and function) as assessed by metagenomic, metatranscriptomic, and metabolomic technologies
Timepoint [3] 352053 0
6 weeks post-initial treatment dose
6 months post-initial treatment dose
Secondary outcome [4] 352054 0
Explore any changes to body mass index (BMI) as assessed via anthropomorphic measurements
Timepoint [4] 352054 0
6 months post-initial treatment dose

Eligibility
Key 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
Minimum age
20 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/11/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 20853 0
New Zealand
State/province [1] 20853 0
Auckland

Funding & Sponsors
Funding source category [1] 300706 0
University
Name [1] 300706 0
University of Auckland Foundation
Country [1] 300706 0
New Zealand
Primary sponsor type
Individual
Name
Associate Professor Justin O'Sullivan
Address
The Liggins Institute
University of Auckland
85 Park Road
Grafton
Auckland, 1023
Country
New Zealand
Secondary sponsor category [1] 300249 0
None
Name [1] 300249 0
Address [1] 300249 0
Country [1] 300249 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301490 0
Health and Disability Ethics Committee
Ethics committee address [1] 301490 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 301490 0
New Zealand
Date submitted for ethics approval [1] 301490 0
20/09/2018
Approval date [1] 301490 0
16/01/2019
Ethics approval number [1] 301490 0
18/STH/188

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87174 0
A/Prof Justin O'Sullivan
Address 87174 0
Liggins Institute
University of Auckland
85 Park Road
Grafton
Auckland 1023
Country 87174 0
New Zealand
Phone 87174 0
+64 09 9239868
Fax 87174 0
Email 87174 0
[email protected]
Contact person for public queries
Name 87175 0
Justin O'Sullivan
Address 87175 0
Liggins Institute
University of Auckland
85 Park Road
Grafton
Auckland 1023
Country 87175 0
New Zealand
Phone 87175 0
+64 09 9239868
Fax 87175 0
Email 87175 0
[email protected]
Contact person for scientific queries
Name 87176 0
Justin O'Sullivan
Address 87176 0
Liggins Institute
University of Auckland
85 Park Road
Grafton
Auckland 1023
Country 87176 0
New Zealand
Phone 87176 0
+64 09 9239868
Fax 87176 0
Email 87176 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This trial will no longer be going ahead


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.