Trial Review

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
ACTRN12616001334493p
Ethics application status
Submitted, not yet approved
Date submitted
30/08/2016
Date registered
26/09/2016
Date last updated
26/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Faecal Microbiota Transplant (FMT) For Obesity and Diabetes: A randomised controlled trial in Townsville.
Scientific title
An assessment of the role of Faecal Microbiota Transplant (FMT) in the treatment of obesity and type 2 diabetes.
Secondary ID [1] 290029 0
Nil
Universal Trial Number (UTN)
U1111-1186-9583
Trial acronym
FMT for Obesity and Diabetes
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 300062 0
Diabetes II 300230 0
Condition category
Condition code
Diet and Nutrition 299949 299949 0 0
Obesity
Metabolic and Endocrine 300106 300106 0 0
Diabetes
Oral and Gastrointestinal 300107 300107 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible participants will be randomised to either the intervention group or the control group. The study population will comprise 80 adults randomised to receive either donor FMT via colonoscopy (40 people) or receive autologous (their own) faecal material (40 people). The intervention group (only 40 people) will receive a faecal transplant from a specimen provided by a healthy donor.
The FMT is done via colonoscopy following homogenisation with 500 ml of normal saline and filtering of any residual solid material via a sterile kitchen strainer. 100-200 g of faecal material is used (dependent on specimen size provided). The colonoscopy for the FMT takes between 5 and 10 minutes to perform and is preformed by one 3 Gastroenterologists involved in the study (Dr Stephen Fairley, Dr Gillian Mahy or Dr Crispin Musumba).
Monitoring of adherence to protocol is done by 2 other medical practitioners, not involved in the study. (Dr Martin McGahan and Dr Alan Nelson). They will be present for 25% pf the FMT procedures performed.

The participants will be followed up by our research nurse on every three month for a twelve month period. The participants will be encouraged to meeting with the research nurse of any adverse outcomes or concerns should these occur between the formal three monthly reviews.
Intervention code [1] 295749 0
Treatment: Other
Comparator / control treatment
The control group (40 people only) will receive an autologous faecal transplant. By comparing the data obtained from the intervention group with that of the control group,the researchers can be assured that the improvements in the condition of the intervention group is caused by the intervention (FMT) and not by any other factor. There are no drug interventions used.
Control group
Active

Outcomes
Primary outcome [1] 299440 0
The primary outcome measure for the first phase of the trial i.e., proportion who achieve 15% or greater reduction in weight in kg from baseline at 6 months will be compared between groups controlling for baseline weight using Chi-square statistics with 95% confidence intervals.
Timepoint [1] 299440 0
6 months
Primary outcome [2] 299602 0
The primary outcome measure for the second phase of the trial i.e., proportion who achieve sustained weight loss of 15% or greater from baseline at 12 months.
Timepoint [2] 299602 0
12 months
Secondary outcome [1] 327151 0
Insulin sensitivity measured by homeostatic model assessment (HOMA) scale and insulin resistance(IR) measured by assessing beta cell function and insulin concentrations.
Timepoint [1] 327151 0
12 months

Eligibility
Key inclusion criteria
Aged 18-65 years, able to understand the plain language summary and competent to make informed consent.
Obese (BMI >= 30), features of MetS (central obesity plus at least one of diabetes, HbA1c >6.5% or 48 mmol/mol, hypertension (BP>140/90), dyslipidemia (TG>1.5 mmol/L and/or HDL-Cholesterol <1.0 mmol/l).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People having,
a) major mental or other illnesses which would preclude consent or affect clinical risk (e.g. cancer diagnosis, known gut polyps).
b) currently taking medication which would affect gut flora (e.g. antibiotics).
c) Pregnant women

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


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/10/2016
Actual
Date of last participant enrolment
Anticipated
5/11/2016
Actual
Date of last data collection
Anticipated
30/01/2018
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6551 0
Townsville Day Surgery - Townsville
Recruitment postcode(s) [1] 14148 0
4810 - Townsville

Funding & Sponsors
Funding source category [1] 294420 0
Other
Name [1] 294420 0
Townsville Day Surgery
Country [1] 294420 0
Australia
Primary sponsor type
Individual
Name
Dr Stephen Fairley
Address
Townsville Day Surgery
1, Martinez Avenue
West End
Townsville, QLD-4810
Country
Australia
Secondary sponsor category [1] 293270 0
None
Name [1] 293270 0
Address [1] 293270 0
Country [1] 293270 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 295845 0
Townsville Hospital Ethics Commitee
Ethics committee address [1] 295845 0
Townsville Research Education Support and Administration (TRESA), Level 1, JCU Clinical School, The Townsville Hospital, 100 Angus Smith Drive , Douglas , QLD , 4814
Ethics committee country [1] 295845 0
Australia
Date submitted for ethics approval [1] 295845 0
15/06/2016
Approval date [1] 295845 0
Ethics approval number [1] 295845 0

Summary
Brief summary
An assessment of the role of FMT in the treatment of obesity and type 2 diabetes.
Eligible participants will be randomised to either the intervention group or the control group. Regardless of allocation group, each participant will receive best practise exercise and weight loss dietary advice (high vegetable intake to maintain healthy microbiome) provided verbally and in writing. Each participant will then undergo a colonoscopy and take an inulin-type fructans supplement orally twice daily for the study duration. The intervention group will receive a faecal transplant from a specimen provided by a healthy donor. The control group will receive an autologous faecal transplant.
Trial website
The website address will be provided once it is done.
Trial related presentations / publications
Nil
Public notes
Nil

Contacts
Principal investigator
Name 68590 0
Dr Stephen Fairley
Address 68590 0
Townsville Day Surgery
1, Martinez Avenue
West End, QLD-4810
Townsville
Country 68590 0
Australia
Phone 68590 0
+61 7 4725 2855
Fax 68590 0
+61 7 4767 7131
Email 68590 0
[email protected]
Contact person for public queries
Name 68591 0
Mrs Jo Anderson
Address 68591 0
Townsville Day Surgery
1, Martinez Avenue
West End, QLD-4810
Townsville
Country 68591 0
Australia
Phone 68591 0
+61 401 498 999
Fax 68591 0
+61 7 4767 7131
Email 68591 0
[email protected]
Contact person for scientific queries
Name 68592 0
Mr Gobalakrishnan Subashchandrabose
Address 68592 0
Townsville Day Surgery
1, Martinez Avenue
West End, QLD-4810
Townsville
Country 68592 0
Australia
Phone 68592 0
+61 431168050
Fax 68592 0
Email 68592 0
[email protected]

No information has been provided regarding IPD availability


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.