P480 The effect of adjuvant therapy (Sinergin®) in induction and maintaining remission in mild and moderate IBD
S. Ichim*1, A. Dimitriu1, C. Gheorghe1, M. Diculescu1, B. Mateescu2, C. Cijevschi Prelipcean3, L. Gheorghe1
1Fundeni Clinical Institute, Gastroenterology, Bucharest, Romania, 2Colentina Hospital, Bucharest, Romania, 3‘Saint Spiridon’ Hospital, Iasi, Romania
Recent studies regarding IBD pathogenesis have shown that in addition to genetic factors, an important role of intestinal microbiota in the perpetuation of intestinal inflammation is well established. Prebiotic OF-IN (oligofructose-inulin) has the ability to modulate not only the composition of the intestinal microbiota, but also its activity in a beneficial way, increasing the butyrate concentrations, which exhibits immunomodulatory and anti-inflammatory properties. The aim of this study was to investigate the anti-inflammatory effect of OF-IN (Sinergin®) supplementation as impact on clinical remission and biomarkers in patients with mild and moderate flare of IBD.
A prospective interventional multi-centre study was conducted between April 2015 and November 2017 in four high-volume Gastroenterology centres. Patients aged between 18 and 70 years, with histological confirmed ulcerative colitis or Crohn’s disease and active flare of IBD of mild or moderate severity (Mayo 3–10, CDAI 150–220) were included. Selected patients were randomised in 2 groups: Group 1 received Sinergin (10 g/day per os) +and conventional therapy and Group 2 received conventional therapy only. Evaluation has been performed in each group at entry, 3, 7, and 11 months and consisted of: clinical evaluation, C Reactive Protein, faecal calprotectin, colonoscopy (optional) and compliance evaluation. Statistical analysis was performed with SPSS and Excel.
Data were obtained from 160 eligible patients who entered prospectively in the study. 21 patients left the study in the first 3 months mainly because of bloating. Most patients were diagnosed with ulcerative colitis (64%) and had mild clinical activity (64%). The most frequent treatment was 5 ASA po. Our study showed a more rapid decrease in CRP and FCP was observed in the Sinergin® group, suggesting that adding a prebiotic (Sinergin®) accelerates induction of remission, although the values did not significantly differ between-groups at T3. Also, progressive induction of remission from 0 to> 60% in both groups, with no significant difference between groups. The proportion of moderately-severe cases decreased significantly along the study, but insignificantly between the two groups except T1 Group1 perhaps due to inflammatory burden at baseline confirmed by CPR and FCP.
Dynamics of biomarkers (FCP, CRP) demonstrate the progressive improvement of intestinal inflammation under conventional and combined therapy with Sinergin®. Further studies on continuous administration of Sinergin in mild-to-moderate IBD should be undertaken because data showed that it might lead to better results in maintaining remission.