ANZCTR - Registration

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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]

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

Inflammatory Bowel Disease

Condition category

Condition code

Oral and Gastrointestinal

Crohn's disease

Oral and Gastrointestinal

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]

Treatment: Other

Comparator / control treatment

Saline capsules

Control group

Placebo

Outcomes

Primary outcome [1]

Change in severity of intestinal inflammation as assessed by endoscopic index score

Timepoint [1]

6 weeks post-initial treatment dose [primary timepoint]
6 months post-initial treatment dose [secondary timepoint]

Secondary outcome [1]

Change in Crohn's disease symptom severity as assessed by Harvey Bradshaw Index (HBI) score

Timepoint [1]

6 weeks post-initial treatment dose
6 months post-initial treatment dose

Secondary outcome [2]

Change in health-related quality of life as assessed by the short inflammatory bowel disease questionnaire (SIBDQ)

Timepoint [2]

6 weeks post-initial treatment dose
6 months post-initial treatment dose

Secondary outcome [3]

Explore any changes to the gut microbiome (diversity, composition and function) as assessed by metagenomic, metatranscriptomic, and metabolomic technologies

Timepoint [3]

6 weeks post-initial treatment dose
6 months post-initial treatment dose

Secondary outcome [4]

Explore any changes to body mass index (BMI) as assessed via anthropomorphic measurements

Timepoint [4]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Auckland Foundation

Address [1]

University of Auckland
Symonds Street
Auckland, 1010
New Zealand

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

20/09/2018

Approval date [1]

16/01/2019

Ethics approval number [1]

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

A/Prof Justin O'Sullivan

Address

Liggins Institute
University of Auckland
85 Park Road
Grafton
Auckland 1023

Country

New Zealand

Phone

+64 09 9239868

Fax

justin.osullivan@auckland.ac.nz

Contact person for public queries

Name

Justin O'Sullivan

Address

Liggins Institute
University of Auckland
85 Park Road
Grafton
Auckland 1023

Country

New Zealand

Phone

+64 09 9239868

Fax

justin.osullivan@auckland.ac.nz

Contact person for scientific queries

Name

Justin O'Sullivan

Address

Liggins Institute
University of Auckland
85 Park Road
Grafton
Auckland 1023

Country

New Zealand

Phone

+64 09 9239868

Fax

justin.osullivan@auckland.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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