Label Observational Study Research Articles

P160 Pan-enteric mucosal inflammation in CD patients treated with vedolizumab – interim results of a prospective observational study using a panenteric capsule (PiilCam CD)

Abstract Background Mucosal healing is associated with improved short- and long-term outcomes in Crohn’s disease (CD). However, the likelihood of reaching mucosal healing differs between segments of the mucosal tract. The prevalence of panenteric mucosal healing is scarcely described. Capsule endoscopy is the prime modality for evaluation of the entire small bowel. Recently, a combined pan-enteric capsule (PillCam Crohn’s capsule (PCCD) that enables evaluation of mucosal inflammation in the entire digestive tract in a single procedure, has been developed. The main aim of our study was to evaluate the rate of panenteric mucosal healing in Crohn’s disease patients treated with vedolizumab (VDZ) after 52 weeks of therapy. The current interim report focuses on the rates of mucosal improvement after 14 weeks of VDZ treatment. Methods This was a prospective open- label observational study. Patients starting vedolizumab (VDZ) for Crohn’s disease underwent a patency capsule (PC) and if it was excreted within 30 hours, enrolled in the study. The patients were evaluated with PCCD at week 0, 14 and 52 of VDZ treatment. Mucosal inflammation was quantified using the Lewis score (LS) and the panenteric Pillcam score (PS). In addition, fecal calprotectin (FC) and CRP levels were measured at each visit. Patients without active mucosal inflammation on week 0 PCCD were excluded from further participation Results We enrolled 30 patients; 5/30 failed PC and were dropped out of the study.Twenty five patients underwent PCCD at week 0 and 19/25 (78%)% -at week14 (six patients were dropped out for either absence of active mucosal inflammation at week 0 (1 patient), treatment discontinuation before week 14 (2 patients) endoscopic activity – 1, withdrawal of consent (1 patient) or loss to follow-up (1 patient)). After 14 weeks of VDZ treatment, there was a significant improvement in LS (median of 900 (interquartile ration (IQR)- 1143)), vs 450 (IQR-750), p=0.013), ES (15 (IQR-18) vs 10 (IQR-11), p=0.012) and FC (996 (IQR-455) vs 742 (IQR -740), p=0.012), while CRP levels were not significantly different. Conclusion VDZ induces significant improvement in mucosal inflammation evaluated by panenteric capsule endoscopy, in addition to a significant improvement in FC levels, after 14 weeks of therapy *The study was supported by IIR grant from Takeda and Medtronic

1184-P: Efficacy of Hydroxychloroquine (HCQ) 400mg in Patients with Poorly Controlled Insulin-Treated Type 2 Diabetes Mellitus

Objective: We retrospectively investigated the effects of adding HCQ 400 mg in patients with type 2 diabetes showing sub-optimal control by basal insulin and other OHA therapy. Method: This is an open label, parallel group, retrospective and multicentre observational study. 123 patients with poorly controlled type 2 diabetes (baseline HbA1c 8.5 ± 0.6%) who are on basal insulin (glargine) with other OHA therapy (metformin 1gm+Sitagliptin 100 mg), were given HCQ 400 mg in addition to insulin. FPG, PPG and HbA1c values, daily insulin dose, body weight and the number of hypoglycemic events were recorded at weeks 0, 12 and 24. Result: HbA1c decreased by 1.6%, from 8.5 ± 0.6% to 6.9 ± 0.8% (P<0.0001) at 24 weeks. FPG and PPG was reduced significantly from 223.7 ± 31 to 121± 19 mg/dl and from 313.2 ± 41 to 161± 21 mg/dl at the end of 24 week (P<0.0001). Required insulin dose was reduced significantly from 29.4 ± 14.5 to 22.1 ± 12.1 units/day (P= 0.0187). Body weight decreased significantly from 69.5 ± 5.2 to 67.0 ± 6.7 kg, (P= 0.0232). Numbers of hypoglycemic events per patient per month were 0.25 ± 0.35. No severe hypoglycemia occurred during the study period. 56% patients achieved HbA1c ≤ 7% at 24 weeks. Conclusion: Administration of HCQ 400 mg resulted in sustained improvement in glycemic control when given as an adjunct to insulin therapy in patients with poorly controlled type 2 diabetes. Disclosure R. Ahmed: None. A. Sharma: None. A. Natarajan: None. D. Agarwal: None. A. Narayanan: None.

Su1161 Eradication of H. pylori Infection in Patients Allergic to Penicillin

Background: Although current standard first-line treatment to eradicate Helicobacter pylori is triple therapy combining a proton pump inhibitor with two antibiotics (mainly clarithromycin and amoxicillin or metronidazole), there is increasing tendency to alter this treatment. Cure rates with first-line 14-day triple therapy in the geographic area including our country can barely reach 45-50%. Modification of standard first-line treatment by adding bismuth subcitrate has been suggested to increase this relatively low cure rates. Aim: The aim of this study was to assess efficacy of adding product containing several probiotic strains as an adjuvant to modified first-line treatment to eradicate H.pylori. Materials and Methods: An open label observational clinical study was designed to compare two patient groups receiving modified triple therapy and bismuth subcitrate (Group 1, n=100) with a regimen consisting of modified triple therapy and bismuth subcitrate plus concomitant NBL probiotic added at the same time (Group 2, n=150). In Group 1, patients were given a 14-day treatment program consisting of lansoprazole 40 mg (b.i.d.), amoxicillin 1 gr (b.i.d.), clarithyromycin 500 mg (b.i.d) and colloidal bismuth subcitrate 300 mg (2 tablets before breakfast and dinner). In Group 2, NBL probiotic (active probiotics: Lactobacillus acidophilus, Enterococcus faecium, Lactobacillus plantarum, Bfidobacterium lactis, Streptococus thermophilus, Bfidobacterium longum, 1.5 x 109 cfu/chewable tablet) tablets (b.i.d) for 14 days was given in addition to the same modified first-line treatment used for Group 1. Eradication was tested by urea breath test (UBT) 6 weeks after completion of treatment. Results: In Group 1, 89 patients were available for follow up and 69 patients eradicated H.pylori. In Group 2, 134 patients were available for follow up and 120 patients eradicated H.pylori. Per protocol and intention to treat eradication rates were 77.5% and 69.0%, respectively for Group1 and were 89.6% and 80,0% respectively for Group 2. Adding NBL probiotic to triple therapy and bismuth subcitrate has led to a statistically significant more successful eradication rates in both PP and ITT analyses (x2 test: P <0.05 and P<0.05). Conclusion: Contradicting results have been reported in previous studies about the effects of probotics in H.pylori eradication. Our results suggest that adding products containing probiotic strains as an adjuvant to modified first-line therapeutic regimen used for eradication of H. pylori infection significantly improves the cure rates.