Introduction A small proportion of patients with Crohn’s disease develop orofacial granulomatosis (OFG), a rare, chronic disfiguring condition of unknown aetiology affecting the oral mucosa and perioral region. Previous studies have suggested that alterations in the oral microbiota may be involved in the pathogenesis of OFG. CD2 is a novel probiotic containing Lactobacillus breviswhich has anti-inflammatory properties, primarily via reduced arginine availability. Previous studies have shown that CD2 reduces oral inflammation in chemotherapy-induced oral mucositis, Behcet’s disease and recurrent aphthous stomatitis. Our aim was to evaluate the tolerability and efficacy of CD2 lozenges in reducing oral inflammation in patients with active OFG.
Method This was a single-centre prospective open-label observational study. Patients were recruited from a specialist OFG clinic between February and August 2014. Patients with active OFG received an eight week course of CD2 lozenges taken four times per day. Patients were reviewed before and after treatment and disease activity assessed by Oral disease activity score (ODAS), Visual analogue scale (VAS) of oral soreness and Global physician assessment (GPA).
Results 28 patients were recruited with 4 patients withdrawing (3 non-compliance, 1 of which had severe learning difficulties; 1 re-classified as aphthous stomatitis). 7 patients failed follow-up leaving 17 patients (9 males) available for final analysis. The median age was 35 years (range 18–70 years) with 5/17 patients diagnosed with concurrent intestinal Crohn’s disease. Before treatment, the median ODAS was 12 (range 2–36), median VAS was 50% (range 0–90%), with 9/17 patients classified as having mild disease, 2/17 moderate and 6/17 severe. Post treatment, the median ODAS was 12 (range 1–34), median VAS was 20% (range 0–70%), with 9/14 patients had mild disease, 7/14 moderate and 1/14 severe.
The reduction in the mean ODAS at 2 months was: 15.5–11.9 = 3.6 (p = 0.044). The mean improvement in oral soreness measured by VAS was: 44%–26% = 18% (p–0.003). There were no adverse events, however one patient discontinued treatment due to severe diarrhoea which resolved upon CD2 cessation.
Conclusion CD2 appears to be safe, well-tolerated and of benefit in reducing oral inflammation and oral soreness in active OFG. Given the marked improvement in oral soreness, CD2 may have a role in symptom relief in other oral inflammatory conditions. Based on these results, a larger double-blind prospective study is recommended. The treatment shows promise as an adjunct to dietary therapy and an alternative to systemic immunosuppression.
Disclosure of interest None Declared.
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