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Trial registered on ANZCTR


Registration number
ACTRN12624000440527
Ethics application status
Approved
Date submitted
27/03/2024
Date registered
10/04/2024
Date last updated
10/04/2024
Date data sharing statement initially provided
10/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of prebiotics and probiotics in Sjögrens syndrome-related dry eye
Scientific title
The efficacy of prebiotics and probiotics in reducing ocular signs and symptoms of Sjögrens syndrome-related dry eye
Secondary ID [1] 311836 0
iRECS5145
Universal Trial Number (UTN)
U1111-1306-1890
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sjögrens syndrome-related dry eye 333367 0
Condition category
Condition code
Eye 330054 330054 0 0
Diseases / disorders of the eye
Inflammatory and Immune System 330118 330118 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment group will receive probiotic and prebiotic supplements.
Probiotic:
- the dose administered: Two capsules daily;
- the duration of administration: four months
- the mode: oral
Probiotic ingredient:
Lactobacillus rhamnosus CUL 63 15.6 billion CFU*
Lactobacillus casei CUL 06 9.5 billion CFU
Lactobacillus acidophilus CUL 21 + CUL 60 7.4 billion CFU
Bifidobacterium animalis ssp. lactis CUL 34 4.3 billion CFU
Lactobacillus plantarum CUL 66 3.2 billion CFU
Streptococcus thermophilus CUL 68 2.3 billion CFU
Lactobacillus fermentum CUL 67 1.4 billion CFU
Bifidobacterium breve Bb-18 1.4 billion CFU
Bifidobacterium bifidum CUL 20 225 million CFU

Prebiotic:
- the dose administered: one sachet of 7.5 g daily. The participants are asked to add the prebiotic sachet to 200 ml of water and mix to consume.
- the duration of administration: four months
- the mode: oral

Prebiotic ingredient:
Sunfiber® partially hydrolysed guar gum (80%), berry juice powder (13%) (tapioca maltodextrin, raspberry juice, strawberry juice, pomegranate juice, elderberry juice, blackcurrant juice, blueberry juice, cranberry juice, acai puree, goji juice), acacia gum (4%), green tea extract (1% containing 50% polyphenols, 30% catechins, 15% EGCG).


Participants will consume both probiotic and prebiotic supplements over the same 4-month period. To monitor adherence to the intervention, participants are asked to return leftover study products at the end of four months (end of trial).
Intervention code [1] 328293 0
Treatment: Other
Comparator / control treatment
The control group will receive maltodextrin as the placebo.
- the dose administered: one sachet and two capsules. The participants are asked to add the maltodextrin sachet to 200 ml of water and mix to consume.
- the duration of administration: four months
- the mode: oral
Control group
Placebo

Outcomes
Primary outcome [1] 337819 0
Dry eye symptoms. This will be assessed as a composite outcome.
Timepoint [1] 337819 0
Baseline, 1 month (primary endpoint) and 4 months from baseline (secondary endpoint).
Secondary outcome [1] 433390 0
Dry eye signs. This will be assessed as a composite outcome.
Timepoint [1] 433390 0
Baseline, 1 month and 4 months from baseline.
Secondary outcome [2] 433392 0
Tear inflammatory biomarkers
Timepoint [2] 433392 0
Baseline, 1 month and 4 months from baseline.
Secondary outcome [3] 433395 0
Change in corneal innervation, Change in immune cell population numbers. This will be assessed as a composite outcome.
Timepoint [3] 433395 0
Baseline, 1 month and 4 months from baseline.

Eligibility
Key inclusion criteria
• Are able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
• Have no probiotic or prebiotic commercial supplements intake in the last three months.
• Currently have been diagnosed with Sjögrens syndrome-related dry eye.
• Are at least 18 years old.
• Are willing to comply with consuming probiotic and prebiotic products and the clinical trial visit schedule.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Are currently taking probiotic or prebiotic commercial supplements. Participants will be advised not to change their diet for the duration of the study.
• Have had eye surgery within 12 weeks immediately before enrolment for this trial.
• Have had previous corneal refractive surgery.
• Have active corneal (the transparent part of eye surface) infection or any active eye disease.
• Have any current ocular injury.
• Are taking oral or topical antibiotics.
• Are currently enrolled in another clinical trial or have participated in a clinical trial within the previous two weeks.
• Are pregnant or lactating.

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)
sealed opaque bags
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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
Statistical analysis is planned to commence on completion of trial monitoring and the submission of the data analysis request form. Any analysis will be conducted as described in this section, unless a documented request is received from the Sponsor and approved by the trial PI.
Data stored in relational databases will be imported into SPSS / STATA software for statistical purposes. Data will be investigated for quality using range checks and frequency distribution. Underlying distributions of variables will be tested. In general, variables measured on an interval scale with a sufficiently large sample size will be considered to follow a normal distribution. Outputs from the statistical analysis such as statistical tables will be copied over to Excel. Graphs will generally not be created from the statistical software. All statistical results will be reported in Excel format. General Linear Mixed Model will be used to look for differences between the groups and between visits for primary outcome measures OSDI and secondary outcome measures TBUT and staining, as well as all other outcome measures

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/03/2024
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
30/10/2024
Actual
Sample size
Target
46
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316182 0
Charities/Societies/Foundations
Name [1] 316182 0
American Academy of Optometry Korb-Exford Dry Eye Career Development Grant
Country [1] 316182 0
United States of America
Primary sponsor type
University
Name
The University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 318366 0
None
Name [1] 318366 0
Address [1] 318366 0
Country [1] 318366 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315002 0
The University of New South Wales Committee C
Ethics committee address [1] 315002 0
Ethics committee country [1] 315002 0
Australia
Date submitted for ethics approval [1] 315002 0
22/11/2023
Approval date [1] 315002 0
31/01/2024
Ethics approval number [1] 315002 0
iRECS5145

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

Contacts
Principal investigator
Name 133386 0
A/Prof Maria Markoulli
Address 133386 0
School of Optometry and Vision Science, Rupert Myers Building (M15), Southern Dr, UNSW, Kensington NSW 2052
Country 133386 0
Australia
Phone 133386 0
+612 9065 7355
Fax 133386 0
Email 133386 0
m.markoulli@unsw.edu.au
Contact person for public queries
Name 133387 0
Azadeh Tavakoli
Address 133387 0
School of Optometry and Vision Science, Rupert Myers Building (M15), Southern Dr, UNSW, Kensington NSW 2052
Country 133387 0
Australia
Phone 133387 0
+61 2 9348 1054
Fax 133387 0
Email 133387 0
a.tavakkolinasab@unsw.edu.au
Contact person for scientific queries
Name 133388 0
Maria Markoulli
Address 133388 0
School of Optometry and Vision Science, Rupert Myers Building (M15), Southern Dr, UNSW, Kensington NSW 2052
Country 133388 0
Australia
Phone 133388 0
+612 9065 7355
Fax 133388 0
Email 133388 0
m.markoulli@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21993Ethical approval  humanethics@unsw.edu.au



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.