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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
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Scientific title
The efficacy of prebiotics and probiotics in reducing ocular signs and symptoms of Sjögrens syndrome-related dry eye
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Secondary ID [1]
311836
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iRECS5145
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Universal Trial Number (UTN)
U1111-1306-1890
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sjögrens syndrome-related dry eye
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Condition category
Condition code
Eye
330054
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0
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Diseases / disorders of the eye
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Inflammatory and Immune System
330118
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0
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Autoimmune diseases
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Intervention/exposure
Study type
Interventional
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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).
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Intervention code [1]
328293
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Treatment: Other
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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
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Dry eye symptoms. This will be assessed as a composite outcome.
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Assessment method [1]
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Ocular Surface Ocular Surface Disease Index (OSDI) and Dry Eye Questionnaire (DEQ-5).
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Timepoint [1]
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Baseline, 1 month (primary endpoint) and 4 months from baseline (secondary endpoint).
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Secondary outcome [1]
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Dry eye signs. This will be assessed as a composite outcome.
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Assessment method [1]
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Noninvasive keratograph break up times (NIKBUTs), tear osmolarity, tear meniscus heights (TMHs), and ocular redness assessed by Keratograph 4 topography. Ocular staining assessed by fluorescein and lissamine green examination on slit lamp biomicroscopy.
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Timepoint [1]
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Baseline, 1 month and 4 months from baseline.
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Secondary outcome [2]
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Tear inflammatory biomarkers
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Assessment method [2]
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ELISA (enzyme-linked immunosorbent assay)
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Timepoint [2]
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Baseline, 1 month and 4 months from baseline.
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Secondary outcome [3]
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Change in corneal innervation, Change in immune cell population numbers. This will be assessed as a composite outcome.
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Assessment method [3]
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In vivo confocal microscopy (IVCM)
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Timepoint [3]
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Baseline, 1 month and 4 months from baseline.
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque bags
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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).
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
13/03/2024
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Date of last participant enrolment
Anticipated
30/06/2024
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Actual
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Date of last data collection
Anticipated
30/10/2024
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Actual
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Sample size
Target
46
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Accrual to date
1
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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American Academy of Optometry Korb-Exford Dry Eye Career Development Grant
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Address [1]
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Country [1]
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United States of America
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Primary sponsor type
University
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Name
The University of New South Wales
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
318366
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Country [1]
318366
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315002
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The University of New South Wales Committee C
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Ethics committee address [1]
315002
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https://research.unsw.edu.au/research-ethics-and-compliance-support-recs
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
315002
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22/11/2023
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Approval date [1]
315002
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31/01/2024
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Ethics approval number [1]
315002
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iRECS5145
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Summary
Brief summary
Our research focuses on finding new ways to help people with a specific type of eye discomfort known as Sjögren's Syndrome-related dry eye. This condition can cause symptoms like dryness, irritation, and reduced tear production, making everyday activities uncomfortable for those affected. Recent studies have shown the association of the gut microbiome with Sjögren's Syndrome. To explore potential new treatments, we are examining how certain food supplements, called prebiotics and probiotics, might help. This is a double-masked, randomized controlled clinical trial in which 46 participants with Sjögren's Syndrome will be randomized through a web-based randomisation system to receive the probiotic and prebiotic or their placebos treatment for 4 months. Our research hypothesis the application of oral probiotics and prebiotics can improve Sjögren's Syndrome-related dry eye.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Maria Markoulli
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Address
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School of Optometry and Vision Science, Rupert Myers Building (M15), Southern Dr, UNSW, Kensington NSW 2052
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Country
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Australia
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Phone
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+612 9065 7355
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Azadeh Tavakoli
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Address
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School of Optometry and Vision Science, Rupert Myers Building (M15), Southern Dr, UNSW, Kensington NSW 2052
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Country
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Australia
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Phone
133387
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+61 2 9348 1054
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Maria Markoulli
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Address
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School of Optometry and Vision Science, Rupert Myers Building (M15), Southern Dr, UNSW, Kensington NSW 2052
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Country
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Australia
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Phone
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+612 9065 7355
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Fax
133388
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
21993
Ethical approval
[email protected]
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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