Vol.:(0123456789) 1 3 Rheumatology International https://doi.org/10.1007/s00296-020-04558-9 CLINICAL TRIALS Probiotics as a prophylaxis to prevent oral candidiasis in patients with Sjogren’s syndrome: a double‑blinded, placebo‑controlled, randomized trial Yasmine Kamal 1  · Mahmoud Kandil 1  · Mervat Eissa 2  · Reham Yousef 3  · Basma Elsaadany 1 Received: 20 January 2020 / Accepted: 14 March 2020 © Springer-Verlag GmbH Germany, part of Springer Nature 2020 Abstract Patients with Sjögren’s syndrome are at a higher risk to develop oral candidiasis than the general population. As antifun- gals have many side-efects, new approaches are needed to address this problem. This randomized controlled study aimed to evaluate the short-term efcacy 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 Bifidobacterium bifidum. 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 signifcant 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 signifcant. 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). Keywords Probiotics · Prophylaxis · Oral candidiasis · Sjogren’s syndrome · Xerostomia Introduction Considered as a complex autoimmune, chronic and sys- temic disease, Sjögren’s syndrome (SS) is characterized by lymphocytic infltration and subsequent destruction of the exocrine glands. It afects mainly the salivary and lacrimal glands [1]. It has been proposed that 88% of SS subjects are liable to reduced salivary fow rate, followed by complaints of xerostomia in the 75–92% range [2]. The diminished lubri- cating, bufering and antimicrobial properties of saliva lead to an intensifed incidence of dental erosion and dental car- ies. Oral ulcerations, angular cheilitis and oral candidiasis together with mucositis are commonly found [3]. Patients with SS are likely to get infected with Candida albicans more frequently than the general population. The candidosis state is generally symptomless in SS [4]. How- ever, fungal infection can be exhibited as tongue fssura- tion, erythematous mucosal lesions and denture-associated stomatitis [5]. Local antifungal and systemic agents have been found to be efective in preventing invasive and mucosal fungal infections. Nevertheless, antifungal drugs have obvious side efects, such as renal and hepatic toxicity, vomiting, nausea and diarrhea [6]. The unpleasant taste of nystatin is also a drawback. Furthermore, the increased rate of resistant strains and antifungal prophylaxis remains challenging [7, 8]. One of the novel strategies used for treatment and prophy- laxis against oral candidiasis is probiotics. Probiotics (e.g., Lactobacillus and Bifidobacterium spp.) are living micro- organisms that confer a health beneft to the host when Rheumatology INTERNATIONAL * Yasmine Kamal dryasminekamal84@gmail.com 1 Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University, Cairo, Egypt 2 Rheumatology, Faculty of Medicine, Cairo University, Cairo, Egypt 3 Clinical and Chemical Pathology, Faculty of Medicine, Cairo University, Cairo, Egypt