None listed
Conditions
Brief summary
Our research focuses on finding new ways to help people with a specific type of eye discomfort known as dry eye disease. 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 dry eye. 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.
Interventions
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
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).
Sponsors
The University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed