1. I n t r o d u c t i o n Arthropathy is commonly observed in patients with IBD. In daily practice, peripheral arthritis, axial arthritis or a combination of both is observed. The prevalence has been reported up to 25% of patients with Crohn’s disease (CD) and 15% of patients with Ulcerative Colitis (UC). In addition enthesiopathy may be found in 5-10%. Arthralgia as isolated symptom is found in 5.3% of patients with UC and in 14.3% of patients with CD. Occurrence of arthralgia may be induced due to immunological reactions against intestinal contents, as can be deduced from established immunoserological reactions against bacteria in combination with increased intestinal permeability. NSAID/ COX2 inhibitors are often efficacious, but may induce a flare-up of IBD. Our aim was to study the safety and efficacy of VSL#3 in an open label trial in patients with quiescent IBD, suffering from arthralgia for at least 2 weeks. PROBIOTICS (VSL#3) IN ARTHRALGIA. PRELIMINARY RESULTS OF AN ONGOING OPEN TRIAL IN PATIENTS WITH ULCERATIVE COLITIS AND CROHN DISEASE Ouafae Karimi, Amado Salvador Peña, Adriaan A. van Bodegraven Depts. Gastroenterology and Laboratory of Immunogenetics, VUMC, Amsterdam, The Netherlands M e t h o d s In 29 patients with quiescent IBD and arthralgia with stable medical therapy, VSL#3 sachets b.i.d. was prescribed for 3 months. One sachet contained 450 billion viable lyophilised bacteria of 4 strains of Lactobacillus, 3 strains of Bifidobacterium, and one strain of Streptococcus salivarius subsp. Thermophilus. which was not IBD related (2), and non- specific gastrointestinal symptoms (5). In contrast, five patients reported improvement of gastrointestinal symptoms, with concomitant increase of general well-being. So far, 17 of 29 patients received VSL#3 for more than one week, of which 12 patients completed the trial. The sex distribution was 10 females and 2 males with a period of disease varying from 3 to 36 years. There were 9 cases of CD and 3 cases of UC. Five patients had a surgical history. IBD activity was assessed by Truelove- Witts or Harvey-Bradshaw score. 7 (6) VAS II score indicated the general well being of the patients at the moment of assessment. The average score was 63 (SD=25) at the start of the study and 70 (SD=30) at the end of the study. R e s u l t s A significant decrease of the Ritchie score from 13.4 to 6.6 (p < 0.01) was observed. There were 12 withdrawals, due to distaste (2), spontaneous improvement (3), deterioration of general well-being C o n c l u s i o n In general, the VAS score was low on average, indicating that arthralgia constitutes a significant clinical burden. These preliminary study results suggest improvement of arthralgia in a subset of patients with quiescent IBD due to VSL#3. Apparently, the intestinal contents do influence the condition of joints in IBD patients. About 30% of patients had adverse events, mainly related to the taste of the product, and which had no effect on the course of IBD. To confirm these data, a randomized placebo-controlled trial is scheduled for the near future. VU University Medical Centre Laboratory of Immunogenetics General well being was assessed by the Visual Analogue Scale. Arthralgia was assessed by the Ritchie score (joints assessed separately and graded for tenderness on a 0-3 scale) at baseline and at week 12. Four strains Lactobacillus L. acidophilus L. casei L. delbruckei subsp. bulgaricus L. plantarum Three strains Bifidobacterium B. longum B. infantis B. brevis One strain Streptococcus S. salivarius subsp. Thermophilus VAS I score indicated the general well- being of the patients in the week before assessment. The average score was 54 (SD=22) at the start of the study and 58 (SD=27) at the end of the study. 54 (22) 58 (27) P =NS N = 12 63 (25) 70 (30) P =NS N = 12 Telephone Rx VSL#3 b.i.d. Phys exam Assessment arthralgia/IBD LAB t = 0t = 6 weeks t = 12 weeks Phys exam Assessment arthralgia/IBD LAB 14 (10) P <0.05 N = 12 7 (6)