PMID- 37256485
OWN - NLM
STAT- Publisher
LR  - 20230531
IS  - 1867-1314 (Electronic)
IS  - 1867-1306 (Linking)
DP  - 2023 May 31
TI  - The Effect of Ophthalmic and Systemic Formulations of Latilactobacillus sakei on 
      Clinical and Immunological Outcomes of Patients With Dry Eye Disease: A 
      Factorial, Randomized, Placebo-controlled, and Triple-masking Clinical Trial.
LID - 10.1007/s12602-023-10079-1 [doi]
AB  - Dry eye disease (DED) is one of the most prevalent eye diseases. This study aimed 
      to evaluate the efficacy and safety of Latilactobacillus sakei (L. sakei) either 
      as an ophthalmic bacterial lysate (drops, no live organism) or as an oral 
      probiotic (capsules) on immunological and clinical outcomes of patients with DED. 
      This study was a randomized, placebo-controlled, triple-masking clinical trial 
      with four parallel arms. Patients were randomly assigned in a 2x2 factorial 
      design combining active vs placebo capsules and active vs placebo eye drops in a 
      1:1x1:1 ratio. The ophthalmic drops are approved for use in the European Union as 
      a medical device (CE registration code 0425-MED-004235). A total of 40 patients 
      were evaluated. DED signs and symptoms decreased significantly by using active 
      drops compared to placebo, as measured by the Ocular Surface Disease Index 
      (OSDI), Tear Break-up Time (TBUT), and Schirmer I tests (all p<0.0001). 
      Conversely, neither active capsules nor their interaction effect with active 
      drops achieved significance vs placebo. There was also a significant decrease in 
      the tear levels of IL-6 (p=0.0007), TNFalpha (p<0.0001), and IFNgamma (p<0.0001) in 
      patients receiving active drops. Intake of both active products (drops and 
      capsules) was well tolerated. Postbiotic ophthalmic formulation containing L. 
      sakei lysate significantly improved the signs and symptoms of DED and suppressed 
      ocular surface inflammatory response. Conversely, oral intake of L.sakei as a 
      probiotic capsule had no effect in these patients (ClinicalTrials.gov: 
      NCT04938908).
CI  - (c) 2023. The Author(s), under exclusive licence to Springer Science+Business 
      Media, LLC, part of Springer Nature.
FAU - Heydari, Mojtaba
AU  - Heydari M
AUID- ORCID: 0000-0001-9612-0936
AD  - Pharmaceutical Sciences Research Center, School of Medicine, Shiraz University of 
      Medical Sciences, Zand St., Shiraz, Iran.
AD  - Poostchi Ophthalmology Research Center, Department of Ophthalmology, School of 
      Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.
FAU - Kalani, Mehdi
AU  - Kalani M
AUID- ORCID: 0000-0003-4478-5957
AD  - Alborzi Clinical Microbiology Research Center, Shiraz University of Medical 
      Sciences, Shiraz, Iran.
FAU - Ghasemi, Younes
AU  - Ghasemi Y
AUID- ORCID: 0000-0003-4172-0672
AD  - Pharmaceutical Sciences Research Center, School of Medicine, Shiraz University of 
      Medical Sciences, Zand St., Shiraz, Iran. ghasemiy@sums.ac.ir.
AD  - Department of Pharmaceutical Biotechnology, School of Pharmacy, Shiraz University 
      of Medical Sciences, Shiraz, Iran. ghasemiy@sums.ac.ir.
FAU - Nejabat, Mahmood
AU  - Nejabat M
AUID- ORCID: 0000-0001-5761-3594
AD  - Poostchi Ophthalmology Research Center, Department of Ophthalmology, School of 
      Medicine, Shiraz University of Medical Sciences, Shiraz, Iran. 
      nejabatm@sums.ac.ir.
LA  - eng
SI  - ClinicalTrials.gov/NCT04938908
GR  - 97-01-104-18912/Shiraz University of Medical Sciences/
PT  - Journal Article
DEP - 20230531
PL  - United States
TA  - Probiotics Antimicrob Proteins
JT  - Probiotics and antimicrobial proteins
JID - 101484100
SB  - IM
OTO - NOTNLM
OT  - Cytokines
OT  - Dry eye disease
OT  - Inflammation
OT  - Latilactobacillus sakei
OT  - Postbiotic
OT  - Probiotic
EDAT- 2023/05/31 13:11
MHDA- 2023/05/31 13:11
CRDT- 2023/05/31 11:12
PHST- 2023/04/18 00:00 [accepted]
PHST- 2023/05/31 13:11 [medline]
PHST- 2023/05/31 13:11 [pubmed]
PHST- 2023/05/31 11:12 [entrez]
AID - 10.1007/s12602-023-10079-1 [pii]
AID - 10.1007/s12602-023-10079-1 [doi]
PST - aheadofprint
SO  - Probiotics Antimicrob Proteins. 2023 May 31. doi: 10.1007/s12602-023-10079-1.