Wall Thickness Ratio-A New Magnetic Resonance Parameter-Is Associated With the Outcome of Biological Therapy in Patients With Ileal and Ileocolonic Crohn's Disease.

GOALS: The present study was aimed at identifying a new magnetic resonance enterography (MRE) parameter assessing the clinical outcome of biological therapy in patients with active ileal/ileocolonic Crohn's disease (CD). BACKGROUND: Transmural healing (TH) has been associated with improved outcomes in CD. However, some patients with clinical remission and inactive disease at endoscopy do not achieve TH. MATERIALS AND METHODS: Ileal/ileocolonic CD patients scheduled for biological therapy were prospectively evaluated, at baseline (T0) and after 1 year of treatment (T1), with Harvey Bradshaw Index score, blood tests, ileocolonscopy, and MRE. Clinical activity was assessed after 2 years of treatment (T2). Wall thickness ratio (WTR) was calculated in the same affected ileal segment, as the ratio between the ileum wall thickness value at T1 and the ileum wall thickness value at T0. RESULTS: A total of 103 patients were included. Mean WTR at T1 in nonresponders was significantly higher than in responders. At receiver operating characteristic analysis, WTR values were significantly associated to biological therapy responsiveness. A WTR cutoff value of 0.77 mm was identified to discriminate responders from nonresponders (sensitivity: 79%; specificity: 67%). In responders, the proportion of patients with a WTR<0.77 was significantly higher than the proportion of patients achieving TH at T1. Among patients achieving endoscopic remission, 11/29 (37.9%) presented TH, while 20/29 (68.9%) presented WTR<0.77 ( P : 0.035). At multivariate logistic regression analysis, WTR<0.77 was significantly associated to biological therapy response. CONCLUSION: WTR index represents an easy-to-calculate MRE parameter and seems to be a promising tool for monitoring therapeutic response in CD patients during biological therapy.

Safety and tolerability of a novel oral nutritional supplement in healthy volunteers.

BACKGROUND AND OBJECTIVE: Foods for Special Medical Purposes (FSMPs) are formulated to support the nutritional needs of subjects with impaired capacity to ingest, digest or absorb ordinary food or nutrients. Polglumyt® is a proprietary highly purified, high quality glycogen obtained from mussels. Here we report the results of a single-center, single dose, open label, single arm study carried out to investigate acceptance (i.e. gastrointestinal tolerance and palatability), metabolic profile and safety of a low osmolarity, high-density energy Polglumyt®-based drink (the investigational product, IP) as a novel FSMP. METHODS: Twelve healthy subjects received a single oral administration of the IP under fasting conditions. The study endpoints were: changes in gastrointestinal system tolerability at 3 h, 6 h and 24 h after IP intake; IP palatability evaluation; metabolic evaluation through the kinetic profile of circulating glucose, insulin and C-peptide from 0 h to 6 h after IP intake and changes from baseline in circulating triglycerides at 3 h and 6 h after IP intake. RESULTS: The IP showed a good gastrointestinal tolerability and an acceptable palatability. The IP did not affect the physiological glycemic profile and the triglycerides levels 6 h after the intake. The IP was well tolerated by study subjects, with no or minor adverse events. CONCLUSIONS: The study results encourage additional clinical investigations on the IP as a novel FSMP in patients with impaired digestion or gastrointestinal absorption, unable to assume an ordinary diet, e.g. patients undergoing invasive gastrointestinal surgery, elderly or oncological patients, even with certain metabolic disorders.

Nutritional status and bioelectrical phase angle assessment in adult Crohn disease patients receiving anti-TNFα therapy.

BACKGROUND: Altered body composition is frequently observed in Crohn's disease (CD) patients. AIMS: To investigate the nutritional status, and the effect of different therapeutic regimes in adult CD patients. METHODS: Fat free mass (FFM) and BIA-derived phase angle (PhA) were assessed in 45 CD patients, 22 on conventional therapy (CT) and 23 on maintenance therapy with infliximab (MT). Nutritional status was also assessed in 12 CD patients before and following the induction protocol with infliximab. BIA data of CD patients were compared with those of 20 healthy asymptomatic volunteers. In CD patients C Reactive Protein (CRP) and albuminaemia dosage were obtained. RESULTS: The mean values of PhA and of FFM were significantly lower in CT patients when compared with control group and MT patients. Following infliximab treatment FFM increased, although not significantly, while mean phase angle value significantly increased from 4.6±0.3 to 6.2±0.4 (p<0.05). CRP was significantly lower in MT patients compared to that in CT patients. CONCLUSION: CD patients on conventional therapy showed a lower FFM and a lower mean phase angle score compared to those on infliximab therapy. Following infliximab treatment the mean phase angle score normalized. PhA is a reliable nutritional indicator in IBD patients and could be considered as an additional tool for assessing response to treatment.

A survey of pharmacological and nonpharmacological treatment of functional gastrointestinal disorders.

BACKGROUND: Treatment of functional gastrointestinal disorders (FGIDs) is based on symptoms relieve by conventional drugs, but increasingly complementary and alternative medicine (CAM) is used. OBJECTIVE: This survey aimed to investigate the current treatments used by FGIDs patients. METHODS: A total of 25 Italian gastroenterologists interviewed outpatients on gastrointestinal symptoms and treatments (pharmacological, CAM, diet/dietary supplements) used during the last year to relieve FGIDs. Consecutive adults with FGIDs according to Rome III were included. RESULTS: Of the 199 patients, 81% used conventional drugs, 64.3% diet/dietary supplements, and 48.7% CAM. Conventional drugs, diet/dietary supplements, or CAM as exclusive treatment were used by 24.6, 6, and 2.5% of patients, respectively. Two-thirds used more than one treatment: 34.7% conventional drugs, CAM, and diet/dietary supplements, 17.1% conventional drugs and diet/dietary supplements, 10.1% diet and CAM, and 5% conventional drugs and CAM. Benefits and adverse effects were similar for conventional drugs and nonpharmacological treatments. Males (OR 2.4) without lower GI symptoms (OR 5.4) used more frequently exclusive pharmacological treatment of FGIDs. CONCLUSIONS: Conventional drugs are the preferred treatment for FGID. CAM and dietary modifications are more likely used as an adjunct to rather than instead of conventional drugs. Adverse effects occurred in all treatments.