Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000324314
Ethics application status
Approved
Date submitted
21/02/2017
Date registered
1/03/2017
Date last updated
18/02/2020
Date data sharing statement initially provided
22/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the feasibility and acceptability of synbiotic supplementation in patients with chronic kidney disease (pre-dialysis)
Scientific title
A randomised, double blind, placebo controlled trial to assess the feasibility and acceptability of synbiotic supplementation in patients with chronic kidney disease
Secondary ID [1] 291197 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
SYNERGY II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 302100 0
Condition category
Condition code
Renal and Urogenital 301723 301723 0 0
Kidney disease
Diet and Nutrition 301733 301733 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a 12-month intervention where patients will be randomised to either intervention or control group. The intervention group will receive prebiotic and probiotics alongside healthy eating for CKD education. Dietary education will be a minimum of 30 minutes in duration and will be based on the Evidence Based Practice Guidelines for the Nutritional Management of Chronic Kidney Disease. Individual, face to face sessions will be conducted by an Accredited Practicing Dietitian who specialises in renal nutrition. During these sessions, the patient will be provided with a pamphlet (from Queensland Health Nutrition Education Materials Online) which outlines key information pertaining to healthy eating for CKD. This will be discussed in detail with the patient, allowing for clarification of any unclear messages. These sessions will occur alongside scheduled clinic visits (baseline, weeks 13, 26, 39 and 52).

Prebiotic dose = 2 x 10g powder/day.
Probiotic dose = 450 billion CFU (1 sachet per day) To be taken in cold non-carbonated drinks or food

Intervention fidelity will be monitored through a supplement count and weighing. Adherence to a stable diet will be monitored using 24hr food recalls.Prebiotic dose = 2 x 10g powder/day.
Probiotic dose = 450 billion CFU (1 sachet per day) To be taken in cold non-carbonated drinks or food

Intervention fidelity will be monitored through a supplement count and weighing. Adherence to a stable diet will be monitored using 24hr food recalls.
Intervention code [1] 297199 0
Treatment: Drugs
Intervention code [2] 297265 0
Treatment: Other
Comparator / control treatment
Participants randomised to the control group will receive a placebo prebiotic powder (waxy maize) and a placebo probiotic sachet (maltodextrin), alongside healthy eating for CKD education. Dietary education will be a minimum of 30 minutes in duration and will be based on the Evidence Based Practice Guidelines for the Nutritional Management of Chronic Kidney Disease. Individual, face to face sessions will be conducted by an Accredited Practicing Dietitian who specialises in renal nutrition. During these sessions, the patient will be provided with a pamphlet (from Queensland Health Nutrition Education Materials Online) which outlines key information pertaining to healthy eating for CKD. This will be discussed in detail with the patient, allowing for clarification of any unclear messages. These sessions will occur alongside scheduled clinic visits (baseline, weeks 13, 26, 39 and 52).
Placebo (waxy maize powder, sachet of maltodextrin)
Control group
Placebo

Outcomes
Primary outcome [1] 301120 0
Feasibility and acceptability of long-term synbiotic supplementation in patients. Assessed as a composite of;
1. recruitment rate
2. retention rate
3. adherence to study product - product dispensed compared with product returned
4. acceptability - qualitative interviews with participants to explore their experience and acceptability of synbiotic supplementation.
Timepoint [1] 301120 0
Baseline and end of intervention (week 52)
Secondary outcome [1] 331776 0
Blood pressure
Timepoint [1] 331776 0
Baseline, mid (week 26) and end of intervention (week 52)
Secondary outcome [2] 331777 0
Plasma lipid profile
Timepoint [2] 331777 0
Baseline, mid (week 26) and end of intervention (week 52)
Secondary outcome [3] 331778 0
Total fasting glucose measured by fasting blood test
Timepoint [3] 331778 0
Baseline, mid (week 26) and end of intervention (week 52)
Secondary outcome [4] 331779 0
Waist circumference
Timepoint [4] 331779 0
baseline, mid (week 26) and end of intervention (week 52)
Secondary outcome [5] 331780 0
Free and protein-bound concentrations of serum indoxyl sulphate. Measured by Ultra Performance Liquid Chromatography (UPLC)
Timepoint [5] 331780 0
baseline, mid (week 26) and end of intervention (week 52)
Secondary outcome [6] 331781 0
Free and protein-bound concentrations of serum p-cresyl sulphate. Measured by Ultra Performance Liquid Chromatography (UPLC)
Timepoint [6] 331781 0
baseline, mid (week 26) and end of intervention (week 52)
Secondary outcome [7] 331782 0
Composite secondary outcome: Plasma lipopolysaccharides, serum zonulin
Timepoint [7] 331782 0
Baseline, mid (week 26) and end of intervention (week 52)
Secondary outcome [8] 331783 0
GUT microbiota – faecal sample, 16s rRNA sequencing
Timepoint [8] 331783 0
Baseline, weeks 13, 26, 39 and end of intervention (week 52)
Secondary outcome [9] 331784 0
Gastrointestinal symptoms - GSRS
Timepoint [9] 331784 0
Baseline, weeks 2, 13, 26, 39 and end of intervention (week 52)
Secondary outcome [10] 331794 0
Bristol Stool Score
Timepoint [10] 331794 0
Baseline, mid (week 26) and end of intervention (week 52)
Secondary outcome [11] 331795 0
Cost; healthcare utilisation and intervention costs. Using a patient reported calendar approach and intervention costs (product supply, dietitian time and consumables)
Timepoint [11] 331795 0
mid (week 26) and end of intervention (week 52)
Secondary outcome [12] 332026 0
Health utility using the Assessment of Quality of Life questionnaire AQoL-4D
Timepoint [12] 332026 0
baseline, mid (week 26) and end of intervention (week 52)
Secondary outcome [13] 367270 0
Left ventricular function measured by global longitudinal strain
Timepoint [13] 367270 0
Baseline and end of intervention (week 52)

Eligibility
Key inclusion criteria
CKD stage III-IV: GFR stable between 15-60 ml/min (for the past 3 months),
Under the care of a nephrologist,
Able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous clinically significant change in immunosuppressant dose within six months determined by the medical team
- Receiving/or have received radiation to the bowel or large bowel resection
- Medically diagnosed and active irritable bowel syndrome, active Crohn’s disease, ulcerative colitis
- Cirrhotic liver disease
- Received prebiotic, probiotic or anti-biotic therapy within 1 month of study commencement
- Unable to understand English
- Unable/unwilling to comply with follow-up
- Life expectancy limited due to pre-existing malignancy or other disease (<6 months)
- Likely to progress to end-stage treatment within 12 months as determined by the treating physician
- Pregnancy
- Severely malnourished (Subjective Global Assessment: C)

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)
Participants will be informed of the purpose, their involvement and potential risks/benefits associated with their involvement. Written information will be provided prior to consenting. Informed, written consent will be obtained upon recruitment of all participants. Randomisation will be performed centrally by a computer with allocation concealed from the investigators
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence randomisation (1:1); stratified by study centre and diabetes
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
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2017
Actual
12/04/2017
Date of last participant enrolment
Anticipated
30/06/2018
Actual
4/07/2018
Date of last data collection
Anticipated
4/07/2019
Actual
10/07/2019
Sample size
Target
126
Accrual to date
Final
68
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7500 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 7657 0
Sunshine Coast University Hospital - Birtinya
Recruitment postcode(s) [1] 15326 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 15570 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 295643 0
Charities/Societies/Foundations
Name [1] 295643 0
PA Research Foundation Project Grant
Country [1] 295643 0
Australia
Funding source category [2] 295650 0
Charities/Societies/Foundations
Name [2] 295650 0
Wishlist Research Grant
Country [2] 295650 0
Australia
Primary sponsor type
Individual
Name
A/Prof Katrina Campbell
Address
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba, Queensland, 4102
Country
Australia
Secondary sponsor category [1] 294489 0
None
Name [1] 294489 0
Address [1] 294489 0
Country [1] 294489 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296960 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 296960 0
Ethics committee country [1] 296960 0
Australia
Date submitted for ethics approval [1] 296960 0
07/06/2016
Approval date [1] 296960 0
21/07/2016
Ethics approval number [1] 296960 0
HREC/16/QPAH/336

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72546 0
A/Prof Katrina Campbell
Address 72546 0
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba, Queensland, 4102
Country 72546 0
Australia
Phone 72546 0
+61 7 3176 5252
Fax 72546 0
Email 72546 0
[email protected]
Contact person for public queries
Name 72547 0
Katrina Campbell
Address 72547 0
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba, Queensland, 4102
Country 72547 0
Australia
Phone 72547 0
+61 7 3176 5252
Fax 72547 0
Email 72547 0
[email protected]
Contact person for scientific queries
Name 72548 0
Katrina Campbell
Address 72548 0
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba, Queensland, 4102
Country 72548 0
Australia
Phone 72548 0
+61 7 3176 5252
Fax 72548 0
Email 72548 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
IPD will not be available


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
SourceTitleYear of PublicationDOI
Dimensions AIDiet Quality and Protein-Bound Uraemic Toxins: Investigation of Novel Risk Factors and the Role of Microbiome in Chronic Kidney Disease2021https://doi.org/10.1053/j.jrn.2021.10.003
N.B. These documents automatically identified may not have been verified by the study sponsor.