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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12617000561381

Ethics application status

Approved

Date submitted

10/04/2017

Date registered

21/04/2017

Date last updated

3/09/2021

Date data sharing statement initially provided

29/10/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Gastrointestinal eradication of multi-resistant gram negative bacteria by faecal microbiota transplantation (FMT)

Scientific title

Gastrointestinal eradication of multi-resistant gram negative bacteria by faecal microbiota transplantation (FMT)

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1190-0776

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

infection

Condition category

Condition code

Infection

Other infectious diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants in the intervention group will receive faecal microbiota transplantation (FMT) via enema from donor stool. Participants will receive enemas weekly for three weeks in total.

Faecal transplants will contain stool from healthy donors who are rigorously screened for infection or co-morbid conditions prior to donation. The stool donations are processed by the principal investigator who is a physician (FRACP) and clinical microbiologist (FRCPA). The stool is transferred to an anaerobic biosafety chamber within 2 hours of passage to preserve the microbes and blended with sterile normal saline and pharmaceutical grade glycerol within the chamber. The final composition of the faecal transplant contians 25% stool, 65% saline and 10% glycerol. Individual transplants are frozen at -80C . The transplants from a minimum of 3 to a maximum of 10 donors will subsequently be pooled prior to the transplants being administered so that every participant in the trial receives the same FMT.

Each transplant consists of a 67mL enema. These will be administered by one of the study investigators all of whom are trained physicians. The procedure should take no more than 30 minutes.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Participants in the control group will be given their own stool in the enema, this will serve as a placebo stool transplant.

Control group

Placebo

Outcomes

Primary outcome [1]

Relative abundance of Gram negative pathogenic organisms in the stool microbial community as assessed by next generation sequencing

Timepoint [1]

1 year post FMT procedure

Secondary outcome [1]

Number of episodes of infection, as assessed by positive culture of clinical specimen (not faeces) for resistant Gram negative organism with same resistance mechanism as detected prior to FMT, in addition to requirement for treatment of this infection with antibiotics.

Timepoint [1]

1 year post FMT procedure

Secondary outcome [2]

Carriage of resistance genes in gut microbiota, as assessed by high throughput DNA sequencing and meta-genomic analysis.

Timepoint [2]

1 year post FMT procedure

Secondary outcome [3]

Observation of changes to gut microbiota occurring post-FMT using high throughput DNA sequencing and meta-genomic analysis.

Timepoint [3]

1 year post FMT procedure

Eligibility

Key inclusion criteria

1. Patients with refractory or recurrent infection–defined as at least 3 episodes of infection requiring at least 3 episodes of antibiotic therapy in preceding 24 months.
2. These infections were caused by a Gram negative bacterium which has acquired clinically important antibiotic resistance. This is defined as reported resistance to one or more of the following antibiotics: meropenem, ceftriaxone, cefepime, ceftazidime, cefalexin, amoxicillin-clavulanate, piperacillin-tazobactam, ciprofloxacin, gentamicin or trimethoprim.

Minimum age

18 Years

Maximum age

85 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Active gastrointestinal infection
Ie bacterial or viral infection causing symptoms of diarrhoea
(colonisation with MRGNB is not considered to be an infection)
2. Pregnancy
3. Current use of antibiotics*
4. Cognitive impairment
5. Perianal inflammation
6. Life expectancy < 1 year
7. Neutropaenia <0.5 X109/L
8. Severe IgE mediated food allergy : urticaria or anaphylaxis
9. At risk of peritonitis: including patients with ascities or peritoneal dialysis
*The use of trimethoprim-sulfamethoxazole is allowed when used for prophylaxis against Pneumocystis infection in immunosuppressed individuals.

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)

allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Permuted block randomisation

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

The sample size for the study was calculated using a binary outcome superiority trial power calculation. From animal study data, we expect at least an approximately 80% success in the intervention group and a 20% elimination rate in the placebo group. Significance level (alpha) was 0.05 with a power of 90%. This yielded a sample size required per group of 10 with a total sample size of 20.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

26/10/2018

Actual

29/10/2018

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [2]

The Queen Elizabeth Hospital - Woodville

Recruitment hospital [3]

Flinders Medical Centre - Bedford Park

Recruitment postcode(s) [1]

5000 - Adelaide

Recruitment postcode(s) [2]

5011 - Woodville

Recruitment postcode(s) [3]

5042 - Bedford Park

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Central Adelaide Local Health Network

Address [1]

The Queen Elizabeth Hospital 11 Woodville Rd Woodville SA 5011

Country [1]

Australia

Funding source category [2]

Other

Name [2]

SA Health and Medical Research Institute

Address [2]

North Terrace Adelaide SA 5000

Country [2]

Australia

Primary sponsor type

Hospital

Name

The Queen Elizabeth Hospital

Address

The Queen Elizabeth Hospital
11 Woodville Rd
South Woodville SA 5011

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Other

Name [1]

SA Health and Medical Research Institute

Address [1]

North Terrace Adelaide SA 5000

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Adelaide local Health Network Ethics Committee

Ethics committee address [1]

The Queen Elizabeth Hospital
Basil Hetzel Institute DX465101
28 Woodville Road
Woodville South SA 5011

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/01/2016

Approval date [1]

13/04/2016

Ethics approval number [1]

HREC/16/TQEH/32

Summary

Brief summary

The emergence of bacteria or germs that have become resistant to most antibiotic treatments is an urgent public health problem. Often called “superbugs”, these germs have the ability to resist treatment with almost all antibiotics and can infect hospitalized as well as healthy people in the community. Superbugs transform previously easily treated minor infections into life-threatening conditions with very few treatment options.  So far efforts to reduce superbug spread in our hospitals have failed to halt the global spread of these organisms. Nor are there new antibiotics in production to deal with this problem. New innovative approaches are needed to deal with this emerging threat. 

The faecal microbiota transplant, also called FMT, is a procedure where stool is collected from healthy donors and delivered to the gut of the recipient.  This is done with the goal of the healthy bacteria from the donor replacing the harmful bacteria in the recipient. The FMT procedure is already proven safe and effective in treating patients with another type of bacterial gut infection called Clostridium difficile.  FMT has also been shown in animal studies and human cases to eliminate gut carriage of certain superbugs called multi-resistant gram negative bacteria. The elimination of gut carriage would both prevent superbug infections developing in the individual and also prevent the spread of these organisms to other persons.

In order to address this growing problem we have designed a study to test the effectiveness of FMT in people who have suffered from recurrent infections with a type of superbug. The goals of this study are to determine if FMT can result in clearance of superbug bacteria from the stool and to observe the effect of FMT on rates of recurrent infections in study participants. In collaboration with South Australian experts in this field the stool will be analysed to determine how FMT affects the range of germs in the gut and their ability to become resistant to antibiotics. 

If successful this study will represent a major scientific advance in our ability to prevent superbug infection and spread. It will open up new treatment possibilities for patients who suffer from superbug infections and benefit the community at large by giving us a new tool to stop the spread of superbugs to others.

Trial website

NA

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Lito Papanicolas

Address

The Queen Elizabeth Hospital Woodville Road Woodville SA 5011

Country

Australia

Phone

+61-88204-7616

Fax

[email protected]

Contact person for public queries

Name

Lito Papanicolas

Address

The Queen Elizabeth Hospital Woodville Road Woodville SA 5011

Country

Australia

Phone

+61-88204-7616

Fax

[email protected]

Contact person for scientific queries

Name

Lito Papanicolas

Address

The Queen Elizabeth Hospital Woodville Road Woodville SA 5011

Country

Australia

Phone

+61-88204-7616

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers who submit a methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data might be shared?

• All data underlying published results after de-identification

What types of analyses could be done with individual participant data?

• To achieve the aims of proposal

When can requests for individual participant data be made (start and end dates)?

From:
From 3 months post-publication to 5 years post publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Proposals should be directed to [email protected]
To gain access data requestors will need to sign a data sharing agreement to access data.
The link to the data is to be advised.

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
2	Study protocol					Study-related document.docx
3	Informed consent form					Study-related document.doc

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.

Trial Review

Documents added manually

Documents added automatically