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Probiotics as a prophylaxis to prevent oral candidiasis in patients with Sjogren's syndrome: a double-blinded, placebo-controlled, randomized trial

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Abstract

Patients with Sjögren's syndrome are at a higher risk to develop oral candidiasis than the general population. As antifungals have many side-effects, new approaches are needed to address this problem. This randomized controlled study aimed to evaluate the short-term efficacy of probiotics in the reduction of oral candidal growth in patients with SS. Thirty-two Sjogren’s syndrome patients were randomly allocated in two groups receiving either Probiotics or placebo capsules twice a day for 5 weeks. The strains included in the probiotic capsule were Lactobacillus acidophilus, Lactobacillus bulgaricus, Streptococcus thermophilus and Bifidobacteriumbifidum. Oral rinse solution samples were collected and candidal levels were determined (CFU/mL) at baseline and after the 5-week experimental period. Pain, erythema and angular cheilitis were also assessed at baseline and after 2, 4 and 5-week. In the probiotic group, there was a statistically significant reduction of the candidal load from baseline to the 5th week respectively. However, the change in candidal load at the same time in the placebo group was not statistically significant. The tested probiotic product may represent an unconventional method to reduce candidal colonization, to prevent oral candidosis in patients with Sjogren’s syndrome.

Clinical trials registration ID NCT03840538 (https://clinicaltrials.gov/show/NCT03840538).

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Acknowledgements

We would like to thank all participants in this study and the Faculty of Pharmacy, Cairo University, for supplying us with the placebo capsules used in the study.

Funding

This study is self-funded and no funding was received by any of the authors.

Author information

Authors and Affiliations

  1. Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University, Cairo, Egypt

    Yasmine Kamal, Mahmoud Kandil & Basma Elsaadany

  2. Rheumatology, Faculty of Medicine, Cairo University, Cairo, Egypt

    Mervat Eissa

  3. Clinical and Chemical Pathology, Faculty of Medicine, Cairo University, Cairo, Egypt

    Reham Yousef

Authors
  1. Yasmine Kamal
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  2. Mahmoud Kandil
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  3. Mervat Eissa
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  4. Reham Yousef
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  5. Basma Elsaadany
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Contributions

All authors have contributed to the design of the study, interpretation of the data, manuscript preparation and critical revisions of the manuscript. All authors have approved the final version submitted for publication and agreed to be held accountable for all aspects of the study. Design of the study: YK, BE, MK, ME and RY. Patient recruitment: ME. Data collection: YK, BE and ME. Random sequence generation: BE. Administration of the treatment: YK., Candidal culture: RY &YK. Assessment of the treatment: YK, MK. Statistical analysis and data interpretation: BE, YK. Manuscript preparation: YK, BE, and MK. Manuscript revision: YK, BE, MK, ME, and RY. All co-authors approve the final manuscript for publication and take full responsibility for the integrity of all parts.

Corresponding author

Correspondence to Yasmine Kamal.

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Conflict of interest

Yasmine Kamal, Mahmoud Kandil, Mervat Eissa, Reham Yousef and Basma ElSaadany declare that they have no competing conflicts of interest. All the authors declare that they have no relationship with the drug company.

Informed consent

A written informed consent was obtained from all the participants included in this study and no identifying information of any participant was included in this paper.

Ethical statement

The protocol for this clinical trial was approved by the Ethics Committee of the Faculty of Dentistry, Cairo University, under the ethical committee number: 15 10 12. All participants have provided written informed consent before the research was initiated. All shared data is in line with ICMJE recommendations.

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Kamal, Y., Kandil, M., Eissa, M. et al. Probiotics as a prophylaxis to prevent oral candidiasis in patients with Sjogren's syndrome: a double-blinded, placebo-controlled, randomized trial. Rheumatol Int 40, 873–879 (2020). https://doi.org/10.1007/s00296-020-04558-9

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  • DOI: https://doi.org/10.1007/s00296-020-04558-9

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