None listed
Conditions
Brief summary
This study investigates the connection between the immune system and dry eye disease, highlighting the significant impact of the gut microbiome on immune modulation and its potential role in chronic systemic inflammation. We hypothesise that probiotics could aid in managing dry eye disease by altering gut dysbiosis and reducing systemic inflammation, suggesting a systematic approach could alleviate symptoms. To explore this, we are conducting a double-masked, randomised controlled clinical trial with participants suffering from mild to severe dry eye. They will receive either probiotics or a placebo for four months, followed by a month of follow-up. The trial aims to assess changes in dry eye symptoms, inflammation levels, corneal nerve health, and systemic microbiome alterations to evaluate the effectiveness of probiotic treatment.
Interventions
This study was conducted as a double-masked, randomised controlled clinical trial involving 41 patients experiencing dry eye discomfort. Using a web-based system, participants were randomly assigned to one of two groups. The treatment group received both oral capsules and sachets, capsules of MULTIBIOTIC™ probiotics ( containing 21 billion colony forming units (CFU) capability of human probiotic isolates of lactic acid bacteria (LAB) and Bifidobacteria including beneficial strains of Lactobacil
This study was conducted as a double-masked, randomised controlled clinical trial involving 41 patients experiencing dry eye discomfort. Using a web-based system, participants were randomly assigned to one of two groups. The treatment group received both oral capsules and sachets, capsules of MULTIBIOTIC™ probiotics ( containing 21 billion colony forming units (CFU) capability of human probiotic isolates of lactic acid bacteria (LAB) and Bifidobacteria including beneficial strains of Lactobacillus Acidophilus Lactobacillus Bifidus and S. Thermophilus) and sachets of NutriKane D as the prebiotics. The control group was given placebo capsules and sachets, both containing Maltodextrin. The duration of the treatment for both groups was four months with the following dosing schedule: The schedule of capsules and sachets, both placebo and treatment is as follows: • One capsules daily • Two sachets daily, one morning and another one evening Participants in this treatment arm will consume both capsules and sachets. An optometrist investigator was conducted the visit Study visits: The study will divide to 5 visits. Visits 1,3,4,5 take between 1.5 -2 hours. Visit 1: Baseline visit at this visit, participants will be randomized to receive the placebo or the treatments. Baseline measurements will also be taken. Visit 2: 1-month visit (1 month±7 days from visit 1) Visit 3: 4-month visit and tablet return visit (4 months ± 7 days from visit 1) Visit 4: follow-up visit (1 month±7 days from visit 4) 1. Comfort 2. Inflammation: tear film inflammatory mediators, neuromediators and clinical parameters 3. Corneal nerve morphology and migration 4. Systemic microbiome changes.
Sponsors
UNSW School of Optometry and Science Vision
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 50 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria: - be able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent - No previous probiotic or fermented product intake in the last three months - Currently have been diagnosed with dry eye disease - Be at least 18 years old - Be willing to comply with the consuming probiotic product and clinical trial visit schedule - Be willing to discontinue all ophthalmic preparations including artificial tears during the study and 72 hours before screening
Exclusion criteria
- Currently taking probiotics or other fermented products. Participants will be advised not to change their diet for the duration of the study. - Any systemic or topical medications that will affect ocular physiology or tear film layer e.g. anti-acne medications such as Roaccutane and corticosteroids or immunosuppressant medications such as Hydrocortisone, Prednisolone. - Any systemic disease that may affect ocular health e.g. diabetes, Graves’ disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögren’s syndrome, Crohn’s disease, elevated CRP, IBS, Inflammatory bowel disease and systemic lupus erythematosus. - Eye surgery within 12 weeks immediately prior to enrolment for this trial - Previous corneal refractive surgery - Active corneal infection or any active ocular disease such as iritis, corneal edema or corneal dystrophies, including anterior membrane dystrophy - Any current ocular injury - Taking oral or topical antibiotics - Be currently enrolled in another clinical trial or have participated in a clinical trial within the previous 2 weeks. - pregnant or lactating
Outcome results
None listed