Assessment of Dietary Adequacy and Quality in a Sample of Patients with Crohn's Disease.

Both under-and over-nutrition are prevalent in patients with Crohn's Disease (CD). The aim of the present study was to evaluate dietary intake and compare it with relevant recommendations during active disease and remission, also taking into consideration the adequacy of energy reporting. Dietary quality was assessed through adherence to the Mediterranean diet and to the European dietary guidelines for cardiovascular disease prevention (CVD-score). Malnutrition was diagnosed with the GLIM criteria. There were 237 patients evaluated (54.9% males, 41.3 ± 14.1 years and 37.6% with active disease). In the total sample, high prevalence of overweight/obesity (61.6%) and low prevalence of malnutrition (11.4%) were observed, whereas 25.5% reported low protein intake in the sub-sample of adequate energy reporters. The mean MedDietScore was 28.0 ± 5.5 and the mean CVD-score was 5.25 ± 1.36, both reflecting moderate dietary quality. Patients with active disease reported higher prevalence of low protein intake, lower carbohydrate, fibers, fruits, vegetables, legumes, and sweets consumption and a lower MedDietScore compared to patients in remission. Consumption of fibers, fruits, vegetables, and legumes while in remission did not result in reaching the recommended intakes, and dietary quality was low as reflected by the MedDietScore. In conclusion, both protein undernutrition and energy overconsumption were prevalent in the current sample and overall patients adhered to a moderate quality diet irrespective of disease stage.

Poor performance of predictive equations to estimate resting energy expenditure in patients with Crohn's disease.

Studies exploring the accuracy of equations calculating Resting Energy Expenditure (REE) in patients with Crohn's disease are lacking. The aim of this study was to investigate the accuracy of REE predictive equations against indirect calorimetry in Crohn's disease patients. REE was measured using indirect calorimetry (mREE) after an overnight fasting. Fourteen predictive equations, with and without body composition analysis parameters, were compared with mREE using different body weight approaches. Body composition analysis was performed using dual X-ray absorptiometry. 186 Crohn's disease outpatients (102 males) with mean age 41.3±14.1 years and 37.6% with active disease were evaluated. Mean mREE in the total sample was 1734±443 kcal/day. All equations under-predicted REE and showed moderate correlations with mREE (Pearson's r or Spearman's rho 0.600-0.680 for current weight, all p-values<0.001). Accuracy was low for all equations at the individual level (28-42% and 25-40% for current and adjusted body weight, respectively, 19-33% for equations including body composition parameters). At the group level, accuracy showed wide limits of agreement and proportional biases. Accuracy remained low when sample was studied according to disease activity, sex, body mass index and medication use. All predictive equations underestimated REE and showed low accuracy. Indirect calorimetry remains the best method for estimating REE of patients with Crohn's disease.

Small bowel enteropathy associated with olmesartan medoxomil treatment.

Sprue-like enteropathy associated with treatment with olmesartan medoxomil, an angiotensin II receptor blocker, has been described recently. Herein, we report two patients who developed chronic severe non-bloody diarrhea, weight loss, and muscle wasting after prolonged use of olmesartan. Histologic and immunohistochemical examination of multiple duodenal biopsies revealed severe villous atrophy. Clinical signs ceased upon drug discontinuation. Physicians should be aware of this enteropathy even if olmesartan has been taken for months or years. Whether this adverse event is specific for olmesartan or is a class effect of angiotensin II receptor blockers is currently unknown. To the best of our knowledge, these case reports are the first reported in Greece.

Simethicone adjunct to polyethylene glycol improves small bowel capsule endoscopy imaging in non-Crohn's disease patients.

BACKGROUND: Currently, there is no standardized protocol for bowel preparation before small bowel capsule endoscopy (SBCE). This study aimed to investigate the effect of simethicone combined with polyethylene glycol (PEG) on the visualization quality (VQ) of the SBCE in patients with or without known or suspected Crohn's disease (CD). METHODS: This observational, prospective, single-center study included consecutive patients undergoing a SBCE between 2007 and 2008. Patients received either a standard bowel cleansing preparation of 2 L PEG and 80 mg simethicone orally 12 and 1 h before SBCE respectively (Group A) or only PEG (Group B). VQ, based on scores for luminal bubbles in frames taken from the small intestine, examination completeness, SBCE diagnostic yield, gastric and small bowel transit times were recorded. RESULTS: Of the 115 patients finally included (Group A, n=56 and Group B, n=59) the cecum was visualized in 103 (89.6%). Simethicone overall improved the VQ in the proximal [OR: 2.43 (95%CI: 1.08-5.45), P=0.032] but not in the distal bowel segment (P=0.064). Nevertheless, this effect was not observed in patients undergoing SBCE for either known or suspected CD. CONCLUSION: Simethicone as an adjunct to PEG for bowel preparation in patients undergoing SBCE significantly improved the VQ in non-CD patients.

Systematic versus Endoscopy-driven Treatment with Azathioprine to Prevent Postoperative Ileal Crohn's Disease Recurrence.

BACKGROUND AND AIMS: Prophylactic azathioprine (AZA) is efficacious in preventing postoperative Crohn's disease (CD) recurrence. However, it is unknown whether AZA should be started immediately after surgery. We compared the efficacy of systematic vs endoscopy-driven AZA in preventing CD recurrence at week 102. METHODS: This prospective, multicentre trial included CD patients undergoing curative resection with ileocolonic anastomosis and at higher risk of recurrence. Patients were randomized to systematic AZA initiated ≤2 weeks from surgery, or endoscopy-driven AZA in which therapy was only initiated in case of endoscopic recurrence (Rutgeerts' score ≥i2) at weeks 26 or 52 following surgery. The primary endpoint was endoscopic remission (i0-i1) at week 102. Secondary endpoints included complete endoscopic remission (i0) and clinical remission. RESULTS: The study was prematurely stopped due to slow recruitment. Between 2005 and 2011, 63 patients (28 male, median age 36 years) were randomized to systematic (n = 32) or endoscopy-driven AZA (n = 31). Twenty-one patients withdrew prematurely (8 clinical recurrence, 6 adverse reactions to AZA, 7 patient's preference). In the endoscopy-driven AZA group, 14 patients had to initiate AZA (11 at week 26, 3 at week 52). Endoscopic remission was achieved by 50% in the systematic and 42% in the endoscopy-driven AZA group (p = 0.521). No difference in secondary endpoints was found. CONCLUSIONS: Systematic AZA therapy in patients at higher risk of postoperative CD recurrence is not superior to endoscopy-driven treatment. Early postoperative endoscopic evaluation between weeks 26 and 52 seems most appropriate to guide further therapy, but larger studies are warranted. (ClinicalTrials.gov NCT02247258.).

Granular cell tumour in a patient with Crohn's disease treated with infliximab: coincidence or causal relationship?

Granular cell tumour (or Abrikossoff's tumour) was first described by Abrikossoff in 1926. This is a rare benign neoplasm of unclear histogenesis that is generally believed to be of nerve sheath origin. Usually, it presents as a solitary lesion, located mainly in the subcutaneous tissue of the head, or the neck, or in the oral cavity, such as a tongue lesion, although it may develop anywhere in the body. Approximately 1-2% of granular cell tumours are malignant. Granular cell tumours are extremely rare in patients with inflammatory bowel disease. To the best of our knowledge, granular cell tumours have never been reported in association either with Crohn's disease or scheduled infliximab treatment. Herein, we report a case of a granular cell tumour that presented as a subcutaneous skin nodule of the right lumbar area without any associated local or systemic symptoms in a 41-year-old woman with Crohn's disease who was receiving scheduled treatment with infliximab (5 mg/kg every 8 weeks) for 7 years.

Adalimumab for the prevention and/or treatment of post-operative recurrence of Crohn's disease: a prospective, two-year, single center, pilot study.

BACKGROUND: Infliximab has shown efficacy at preventing post operative recurrence (POR) of Crohn's disease (CD). This study aimed at evaluating whether adalimumab can prevent and treat POR of CD. METHODS: This prospective, single-center, open-label, two-year study included 23 patients who had undergone ileocecal resection for refractory or complicated CD and were at high-risk for POR. Patients received adalimumab from post operative day 14 (Group I, n=8) or at 6 months post operatively after confirmation of endoscopic recurrence (PO-ER) despite treatment with azathioprine, infliximab, or 5-ASA (patients intolerant to infliximab and azathioprine, Group II, n=15). Symptom assessment and laboratory tests were performed at monthly visits. Endoscopic findings were graded using the Rutgeerts score (RS) at 6 and 24 months after initiation of adalimumab. Primary end-points were maintenance (group I) or achievement of mucosal healing (Group II). Secondary end-points were prevention of post operative clinical recurrence (PO-CR) (Group I) and endoscopic and clinical improvement (group II). RESULTS: In Group I, PO-ER (RS≥i2) was seen in one patient at 6 months PO, whereas a second patient developed PO-ER and PO-CR after 24 months of treatment. In Group II, all patients had PO-ER whereas 9 (60%) patients had PO-CR at study enrolment; after 24 months of treatment 9/15 (60%) patients achieved complete (RS-i0, n=3) or near complete (RS-i1, n=6) mucosal healing and 5/9 (56%) clinical remission. No serious adverse events were reported. CONCLUSIONS: This pilot study suggests that adalimumab may prevent PO-ER and treat PO-ER/CR in high risk patients for POR of CD.

A prospective randomized observer-blind 2-year trial of azathioprine monotherapy versus azathioprine and olsalazine for the maintenance of remission of steroid-dependent ulcerative colitis.

OBJECTIVE: The aim of this prospective study was to assess whether the coadministration of azathioprine (AZA) and olsalazine is superior to AZA monotherapy in maintaining remission of steroid-dependent ulcerative colitis (UC). METHODS: Patients with steroid-dependent UC in remission were randomized to receive AZA alone (2.2 mg/kg) or in combination with olsalazine (0.5 g tid). Remission was defined as steroid withdrawal, an Ulcerative Colitis Clinical Activity Index (UCCAI) score of <2, an Ulcerative Colitis Disease Activity Index (UCDAI) score of 0, and a negative colonoscopy and histology. Patients were followed in the outpatient clinic every month for 2 yr. The study protocol included 1) monthly clinical examination, assessment of UCCAI, hematological and biochemical tests, and compliance with treatment; 2) a sigmoidoscopy and completion of inflammatory bowel disease quality-of-life questionnaire (IBD-Q) and UCDAI every 3 months; and 3) total colonoscopy with biopsies at the end of the first and second year of the trial. RESULTS: Seventy patients were randomized to receive AZA alone (n = 34) or with olsalazine (n = 36). Three patients in each group developed side effects or could not comply with treatment and were withdrawn from the study. Three patients receiving AZA relapsed after the first year of the study and three after the second year of the study (19%). In the combination therapy group four patients relapsed after the first year of study and two after the second year of the study (18%). Relapse rates were not significant whether analyzed by intention-to-treat or per protocol. There were no significant differences between groups in time to relapse or discontinuation of treatment, UCCAI, UCDAI, or IBD-Q scores. However, the number of adverse events and the cost of treatment were significantly higher, whereas compliance with treatment was poorer in the combination therapy. CONCLUSION: Patients with steroid-dependent UC successfully maintained in remission on AZA are not in need of 5-aminosalicylic acid compounds.

Budesonide versus mesalamine for maintaining remission in patients refusing other immunomodulators for steroid-dependent Crohn's disease.

BACKGROUND & AIMS: To compare the efficacy of controlled-release budesonide capsules with that of mesalamine for maintaining remission and improving quality of life (QOL) in patients with steroid-dependent Crohn's disease. METHODS: Fifty-seven patients (25 men; mean age, 32 +/- 10.1 yr) with quiescent steroid-dependent Crohn's ileitis, ileocolitis, or colitis (Crohn's disease activity index <150) entered a prospective, investigator-blind trial. Patients were eligible for treatment with azathioprine but had not consented or had developed side effects. Patients were randomized to receive budesonide 6 mg/day (n = 29) or mesalamine 1 g 3 times/day (n = 28). Follow-up assessments were made every 2 months for up to 1 year or until relapse. At each visit, quality of life (QOL) was assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ). RESULTS: There were no significant differences in baseline clinical characteristics between the study groups. The 1-year relapse rate was significantly lower in the budesonide group than in the mesalamine group (55% vs. 82%; 95% confidence interval, 12.4%-41%; P = 0.045). Patients assigned to budesonide also remained in remission longer (241 +/- 114 days vs. 147 +/- 117 days; 95% confidence interval, 32.7-155.3 days; P = 0.003). Compared with mesalamine, budesonide treatment also was associated with a better QOL throughout the study (mean total IBDQ scores 165 +/- 36 vs. 182 +/- 28, respectively; 95% confidence interval, -0.4 to 34.4, P = 0.0001). This advantage was confirmed in patients' self-assessed QOL scores. CONCLUSIONS: Over a 1-year period, controlled-release budesonide was significantly more effective than mesalamine for maintaining remission and improving the QOL of patients with steroid-dependent Crohn's disease.

Omeprazole triple therapy versus omeprazole quadruple therapy for healing duodenal ulcer and eradication of Helicobacter pylori infection: a 24-month follow-up study.

OBJECTIVE: To evaluate the efficacy of omeprazole triple therapy versus omeprazole quadruple therapy for Helicobacter pylori infection. DESIGN: Prospective, randomized, single-centre, investigator-blind study. SETTINGS: Departments of Gastroenterology and Histopathology, Evangelismos Hospital, Athens, Greece. METHODS: One hundred and forty-nine consecutive patients with active duodenal ulcer were randomized to receive omeprazole (20 mg b.d.), amoxicillin (1 g b.d.) and clarithromycin (0.5 g b.d.) (OAC, n = 78), or omeprazole (20 mg b.d.), colloidal bismuth subcitrate (120 mg q.i.d.), metronidazole (0.5 g t.i.d.) and tetracycline hydrochloride (0.5 g q.i.d.) (OBMT, n = 71) for 10 days. Patients' symptoms were scored, and compliance and treatment-related side effects were assessed. Endoscopy was performed before treatment and at 10-12 weeks and 12 months after treatment. H. pylori infection and its successful eradication were sought by histology, immunohistochemistry and campylobacter-like organisms (CLO) tests on multiple biopsies taken from the gastric antrum, corpus and fundus. Patients were re-evaluated clinically and underwent a C-urea breath test (UBT) at 21-24 months. Those with dyspepsia and/or recrudescence of H. pylori were re-endoscoped. RESULTS: Patient groups were comparable for age, sex, smoking, occasional use of nonsteroidal anti-inflammatory drugs (NSAIDs), and current or past bleeding episodes. Six and seven patients in the OAC and OBMT treatment groups, respectively, were lost to follow-up. Eight patients were non-compliant. Two ulcers in the OAC group and one in the OBMT group did not heal. By intention-to-treat (ITT) and per-protocol (PP) analyses, ulcer healing rates were 86% (67/78) and 97% (67/69), respectively, for the OAC group, and 82% (58/71) and 98% (58/59), respectively, for the OBMT group. H. pylori eradication at 10-12 weeks after treatment was 78% (61/78) and 88% (61/69) for OAC, and 65% (46/71) and 78% (46/59) for OBMT, by ITT and PP analyses, respectively (P > 0.1). Side effects were more common with OBMT. Relapse rates of H. pylori were 3% and 2% for the first and second years, respectively. Four H. pylori-negative patients developed reflux symptoms, but only two developed erosive oesophagitis between 12 and 24 months. CONCLUSIONS: OAC and OBMT were equally effective in healing active duodenal ulcers and eradicating H. pylori, but OAC should be used as a first-line treatment because of its better tolerance.