A multi-element psychosocial intervention for early psychosis (GET UP PIANO TRIAL) conducted in a catchment area of 10 million inhabitants: study protocol for a pragmatic cluster randomized controlled trial

Multi-element interventions for first-episode psychosis (FEP) are promising, but have mostly been conducted in non-epidemiologically representative samples, thereby raising the risk of underestimating the complexities involved in treating FEP in 'real-world' services

Clinical relevance of small-bowel findings detected by wireless capsule endoscopy

Objective. Capsule endoscopy is becoming known as a valid tool for identifying sources of obscure gastrointestinal (GI) bleeding. Fewer data are available about its clinical value for other indications. Material and methods. Sixty patients ( 31 F, mean age 47 years, range 14 - 80 years) with no signs of overt GI bleeding were investigated by Given M2A video capsule for suspected small-bowel disease. The main clinical features were: iron deficient anemia ( 20), abdominal pain ( 12), chronic diarrhea ( 9), malabsorption and weight loss ( 7), Crohn's disease ( CD) ( 5), and familial adenomatous polyposis ( 3). Three patients underwent wireless endoscopy for suspected GI neoplasm and one for portal thrombosis. Results. Complete vision of the small bowel was achieved in 55 patients. No small-bowel lesions were identified in 17 patients, but 5 of them had gastric abnormalities. Small-bowel abnormality was found in 38 patients. Lesions compatible with CD were found in 14 patients, diffuse or patchy enteropathy in 7 and polyps in 6. Actively bleeding lesions were detected in 6 patients and potential bleeding sources in 5. Capsule endoscopy had an overall diagnostic yield of 62%. In particular, three small-bowel malignancies were detected and 9 patients received a better definition of their already-known pathology. However, further endoscopies were needed in 10 patients to obtain a diagnosis. One patient, diagnosed with ileal CD, underwent surgery, as the capsule remained trapped in a stricture. Conclusions. Wireless endoscopy effectively visualizes small-bowel abnormalities even though more accurate selection of the patients is needed in order to optimize its diagnostic efficacy

Esophageal involvement in juvenile localized scleroderma: a pilot study.

Abstract OBJECTIVES: To evaluate the esophageal involvement in patients with juvenile localized scleroderma (JLS). METHODS: A cohort of patients with JLS underwent esophageal stationary manometry to evaluate esophageal motility and lower esophageal sphincter (LES) function, distal esophagus 24-hour pH-monitoring to detect gastroesophageal reflux (GER) and upper gastrointestinal (GI) endoscopy to evaluate the presence of esophagitis. RESULTS: Fourteen patients (10 female, mean age 13.3 yrs, mean disease duration 4.7 yrs), took part in the study. Ten had linear scleroderma, three deep morphea, and one generalized morphea. Esophageal abnormalities were found in 8/14 patients (57%): pathological acid exposure on 24-hour pH-monitoring was found in 7; non-specific esophageal motor abnormalities in 5 and endoscopy-proved esophagitis in 5 symptomatic patients. Interestingly, 5 out of 8 patients with esophageal abnormalities were found to be ANA positive, and 2 were also RF positive. CONCLUSION: Esophageal involvement is not unusual in patients with juvenile localized scleroderma, even in the absence of specific symptoms. These preliminary findings, if confirmed in a larger cohort of patients, may support the indication for an extensive GI evaluation especially in presence of positive autoantibodies or specific GI symptoms

Use of alternativeand complementary therapies by inflammatory bowel disease patients in an Italian tertiary referral centre

Abstract: Background. Alternative and complementary therapies are increasingly used by patients with inflammatory bowel disease, but no data are available on their use in Italy. Aim. To ascertain the prevalence and pattern of the use of alternative and complementary therapies, and demographic and clinical factors associated with their use in a large sample of Italian inflammatory bowel disease patients. Methods. A structured questionnaire was administered to a cohort of outpatients at a tertiary referral centre. Results. Five hundred and fifty-two patients completed the questionnaire; 156 (28%) reported using alternative and complementary therapies, which mainly involved homeopathy (43.6%), followed by controlled diets or dietary supplements (35.5%), herbs (28.2%), exercise (25.6%) and prayer (14.7%). Alternative and complementary therapies were used to ameliorate intestinal symptoms (52.5%), in the hope of being cured (41%) and to reduce the intake of drugs (39.7%). An improvement in well-being (45.5%) and inflammatory bowel disease symptoms (40.3%) were the most commonly reported benefits. A higher education (p = 0.027), a more frequently relapsing disease (p = 0.001) and dissatisfaction with the doctor's communication (p = 0.001) correlated with alternative and complementary therapy use. Non-compliance with conventional drugs, disease severity and curiosity regarding novel therapies were predictors of alternative and complementary therapy use. Conclusions. Alternative and complementary therapies are frequently used by Italian inflammatory bowel disease patients. Doctors should improve their empathy and their understanding about possible benefits of altemative and complementary therapies. (c) 2007 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved

Rectal Administration of Lactobacillus casei DG Modifies Flora Composition and Toll-Like Receptor Expression in Colonic Mucosa of Patients with Mild Ulcerative Colitis.

BACKGROUND: An imbalance in gut microbiota seems to contribute to the development of chronic inflammatory disorders of the gastrointestinal tract, such as ulcerative colitis (UC). Although it has been suggested that probiotic supplementation is an effective approach to colitis, its effects on intestinal flora and on mucosal cytokine balance have never been explored. AIM: To evaluate the effect of Lactobacillus casei (L. casei) DG, a probiotic strain, on colonic-associated microbiota, mucosal cytokine balance, and toll-like receptor (TLR) expression. METHODS: Twenty-six patients with mild left-sided UC were randomly allocated to one of three groups for an 8-week treatment period: the first group of 7 patients received oral 5-aminosalicylic acid (5-ASA) alone, the second group of 8 patients received oral 5-ASA plus oral L. casei DG, and the third group of 11 patients received oral 5-ASA and rectal L. casei DG. Biopsies were collected from the sigmoid region to culture mucosal-associated microbes and to assess cytokine and TLR messenger RNA (mRNA) levels by quantitative real-time polymerase chain reaction (RT-PCR). RESULTS: 5-ASA alone or together with oral L. casei DG failed to affect colonic flora and TLR expression in a significant manner, but when coupled with rectally administered L. casei DG, it modified colonic microbiota by increasing Lactobacillus spp. and reducing Enterobacteriaceae. It also significantly reduced TLR-4 and interleukin (IL)-1\u3b2 mRNA levels and significantly increased mucosal IL-10. CONCLUSIONS: Manipulation of mucosal microbiota by L. casei DG and its effects on the mucosal immune system seem to be required to mediate the beneficial activities of probiotics in UC patients

Calprotectin and lactoferrin in the assessment of intestinal inflammation and organic disease

Background and aims Calprotectin and lactoferrin are specific neutrophil-derived proteins, which can be measured in the feces because they are released by cells in inflammatory conditions. We evaluated the efficacy of calprotectin and lactoferrin in detecting organic disease as assessed by colonoscopy. Methods The study comprised 144 patients undergoing colonoscopy for lower gastrointestinal symptoms (abdominal pain, altered bowel habits, and bloody stools) (67), or inflammatory bowel disease activity, or surveillance for dysplasia (77). A single stool sample was assayed for calprotectin and lactoferrin. The proportion of patients correctly diagnosed with each test and the relationship with endoscopic and histological findings were measured. Results Fecal excretion of calprotectin significantly correlated with the finding of colonic inflammation at endoscopy, both in ulcerative colitis and in Crohn's disease (p < 0,001 and p < 0,008, respectively), while lactoferrin excretion significantly correlated with histological inflammation (p=0.001 and p=0.009 respectively). Recommended cut-off values need to be adjusted in the inflammatory bowel disease group. Overall sensitivity, specificity, positive predictive value, and diagnostic efficacy were 78, 83, 86, and 80% for calprotectin and 80, 85, 87, and 81% for lactoferrin, respectively. Conclusionsv Fecal calprotectin and lactoferrin appear to be equally recommendable as inflammatory disease markers in patients with lower gastrointestinal symptoms. Both tests are needed to accurately discriminate activity in inflammatory bowel disease patients

Interaction between rifaximin and dietary fibre in patients with diverticular disease.

Abstract: Background: Cyclic administration of rifaximin in association with dietary fibre achieves symptomatic relief in uncomplicated diverticular disease (DD) by means of a still undefined mechanism. Aim: To investigate the effects of a combination of rifaximin and fibre on both hydrogen production by intestinal microflora and oro-anal transit time. Methods: In a controlled, double-blind crossover trial, 64 patients with uncomplicated DD were given bran (20 g/day) and randomly treated with rifaximin (1200 mg/day) or a placebo for 14 days. Evaluation was based on clinical status, breath test, oro-anal transit time and faecal weight. Results: The global symptomatic score was significantly reduced after rifaximin (7.1 +/- 4.1 to 4.1 +/- 3.3; P < 0.005) but not after placebo (6.8 +/- 3.8 to 6.1 +/- 3.5). Hydrogen production significantly increased after placebo from 198 +/- 134 to 267 +/- 161 ppm/min, while Rifaximin reduced it from 222 +/- 187 to 166 +/- 131 ppm/min (P = 0.05). The total oro-anal transit time decreased from 56.1 +/- 28.2 to 51.3 +/- 28.0 h in placebo and from 54.4 +/- 31.9 to 45.1 +/- 32.4 h (P < 0.05) in rifaximin-treated patients. Conclusions: The administration of rifamixin improves the benefits of dietary fibre in uncomplicated DD by preventing its bacterial degradatio

Increased intestinal permeability and NOD2 variants in familial and sporadic Crohn's disease

Abnormal barrier function may be genetically determined in Crohn's disease. To examine the role of abnormal intestinal permeability in genetic predisposition in multiplex vs. sporadic Crohn's disease families. Intestinal permeability was measured in patients, relatives and partners by means of lactulose/mannitol test. Healthy subjects from the hospital staff served as controls. CARD15 mutations were investigated in sporadic and familial Crohn's disease patients and in a group of blood donors. The median lactulose/mannitol ratio was increased significantly in Crohn's disease patients vs. their relatives [0.03 (0.01-0.24) vs. 0.01 (0.003-0.19), P = 0.005]. The percentage of abnormal tests was significantly higher in familial vs. sporadic first-degree relatives of Crohn's disease patients (29% vs. 11%, P = 0.0281). Abnormal permeability occurred significantly more frequent in patients with familial Crohn's disease carrying the frameshift mutation. The frameshift mutation 3020msC was associated with increased permeability in 75% in the multiplex and in 61% of the sporadic CD patients. One partner had abnormal lactulose/mannitol ratio. Intestinal permeability is raised in Crohn's disease patients and relatives, with higher rates in familial vs. sporadic healthy relatives. CARD15 mutations are associated with abnormal permeability in ileal Crohn's disease