Poliprotect vs Omeprazole in the Relief of Heartburn, Epigastric Pain, and Burning in Patients Without Erosive Esophagitis and Gastroduodenal Lesions: A Randomized, Controlled Trial.

INTRODUCTION: In the treatment of upper GI endoscopy-negative patients with heartburn and epigastric pain or burning, antacids, antireflux agents, and mucosal protective agents are widely used, alone or as add-on treatment, to increase response to proton-pump inhibitors, which are not indicated in infancy and pregnancy and account for significant cost expenditure. METHODS: In this randomized, controlled, double-blind, double-dummy, multicenter trial assessing the efficacy and safety of mucosal protective agent Poliprotect (neoBianacid, Sansepolcro, Italy) vs omeprazole in the relief of heartburn and epigastric pain/burning, 275 endoscopy-negative outpatients were given a 4-week treatment with omeprazole (20 mg q.d.) or Poliprotect (5 times a day for the initial 2 weeks and on demand thereafter), followed by an open-label 4-week treatment period with Poliprotect on-demand. Gut microbiota change was assessed. RESULTS: A 2-week treatment with Poliprotect proved noninferior to omeprazole for symptom relief (between-group difference in the change in visual analog scale symptom score: [mean, 95% confidence interval] -5.4, -9.9 to -0.1; -6.2, -10.8 to -1.6; intention-to-treat and per-protocol populations, respectively). Poliprotect's benefit remained unaltered after shifting to on-demand intake, with no gut microbiota variation. The initial benefit of omeprazole was maintained against significantly higher use of rescue medicine sachets (mean, 95% confidence interval: Poliprotect 3.9, 2.8-5.0; omeprazole 8.2, 4.8-11.6) and associated with an increased abundance of oral cavity genera in the intestinal microbiota. No relevant adverse events were reported in either treatment arm. DISCUSSION: Poliprotect proved noninferior to standard-dose omeprazole in symptomatic patients with heartburn/epigastric burning without erosive esophagitis and gastroduodenal lesions. Gut microbiota was not affected by Poliprotect treatment. The study is registered in Clinicaltrial.gov (NCT03238534) and the EudraCT database (2015-005216-15).

An Extragenital Colonic Salpingiosis.

Endosalpingiosis is a rare condition characterized by the presence of benign fallopian tubal-like glandular epithelium derived from Mullerian ducts, usually affecting the serosal surfaces of the pelvis and peritoneum. It is histologically differentiated from endometriosis as endosalpingiosis lacks endometrial stroma. Endosalpingiosis tends to affect older women and has been associated with ovarian serous tumors of low malignant potential. The extragenital endosalpingosis is typically without symptoms, reported only once as chronic pelvic pain. It rarely affects the appendix but can be mistaken for acute appendicitis or appendiceal tumors. No reports of endoscopic findings have been never described. Its treatment is challenging and provides a multidisciplinary approach with gynecologist, surgeon and gastrointestinal endoscopist. Our case reports for the first time an endoscopic finding of colonic salpingiosis and it is challenging both for the diagnosis and for the treatment.

Impact of COVID-19 Pandemic on Colorectal Cancer Screening Program.

INTRODUCTION: One of the main clusters of coronavirus disease-2019 (COVID-19) has been identified in Italy. Following European and local guidelines, Italian endoscopy units modulated their activity. We aimed at analyzing the need and safety to continue selective colorectal cancer screening (CRCS) colonoscopies during the COVID-19 pandemic. PATIENTS AND METHODS: We carried out a retrospective controlled cohort study in our "COVID-free" hospital to compare data of the CRCS colonoscopies of the lockdown period (March 9 to May 4, 2020) with those of the same period of 2019 (control group). A pre/post endoscopic sanitary surveillance for COVID-19 infection was organized for patients and sanitary staff. RESULTS: In the lockdown group, 60 of 137 invited patients underwent endoscopy, whereas in the control group, 238 CRCS colonoscopies (3.9-fold) were performed. In the lower number of examinations during the lockdown, we found more colorectal cancers (5 cases; 8% vs. 3 cases; 1%; P = .002). The "high-risk" adenomas detection rate was also significantly higher in the "lockdown group" than in controls (47% vs. 25%; P = .001). A multiple regression analysis selected relevant symptoms (hazard ratio [HR], 3.1), familiarity (HR, 1.99), and lockdown period (HR, 2.2) as independent predictors of high-risk lesions (high-risk adenomas and colorectal cancer). No COVID-19 infections were reported among staff and patients. CONCLUSIONS: The overall adherence to CRCS decreased during the pandemic, but the continuation of CRCS colonoscopies was efficacious and safe.

Ulcerative colitis and granulocyte-monocyte-apheresis: safety and efficacy of maintenance therapy during pregnancy.

Inflammatory bowel disease characteristically affects young adults in their reproductive ages. Thus the medication used for the treatment of active disease should not compromise fertility and, also, should not have teratogenic effect on baby. A lot of data are available about effects of steroids, antibiotics, and mesalazine but no data are available about safety and efficacy of granulocyte-monocyte-apheresis (GMA) during pregnancy. In this case report, the 37 year-old pregnant woman with chronically active and steroid dependent ulcerative colitis (UC), at risk of abortion, refused more aggressive pharmacological therapeutic options and gave the informed consent to GMA. To minimize symptoms and the risk of severe clinical relapse, a maintenance GMA treatment was performed throughout pregnancy. The course of pregnancy was uneventful with no side effects; the mother and the baby were all healthy and well at the delivery.

[Predictors of clinical response in patients with ulcerative colitis treated with granulocyte-monocyte apheresis: analysis of the apheresis registry data]. / Predittori di risposta clinica in pazienti affetti da colite ulcerosa trattati con granulocito-monocito aferesi: analisi dei dati del registro aferesi.

We analyzed predictors of clinical response after a cycle of granulocytemonocyte apheresis in 173 patients with ulcerative colitis. Hemoglobin levels independently predicted good clinical outcome.

The Italian Registry of Therapeutic Apheresis: granulocyte-monocyte apheresis in the treatment of inflammatory bowel disease. A multicentric study.

Leukocytes are thought to play an important role in the pathogenesis of inflammatory bowel diseases; granulocyte-monocyte adsorptive (GMA) apheresis, an extracorporeal technique aimed at removing activated circulating leukocytes from the blood, may represent a safe and effective therapeutic tool in these patients. The Italian Registry of Therapeutic Apheresis performed an observational, multicentric study involving 24 Gastroenterology Units. In this study, laboratory data and clinical outcomes of 230 patients (148 males, mean age 43.5 years) affected with ulcerative colitis (UC, n = 194) or Crohn's disease (CD, n = 36) who underwent one or more cycles of GMA were analyzed. Each cycle consisted of five GMA treatments. The patients were followed up for a mean of 8.7 (min. 3 to max. 12) months. At 3 months, positive outcome was achieved in 77.7% of UC patients (72.0% remission, 5.7% clinical response) and 61.3% of CD patients (54.8% remission, 6.5% clinical response). The cumulative proportion of positive outcome at 12 months was 87.1% for UC patients (83.7% remission, 3.4% clinical response) and 77.4% for CD patients (74.2% remission, 3.2% clinical response). No single clinical or laboratory parameter among those analyzed (age, sex, disease characteristics, history of smoking, medication history, baseline values of clinical activity index (CAI)/Crohn's disease activity index (CDAI), hemoglobin, white blood cells count, and erythrocyte sedimentation rate) was independently associated with clinical outcome. The procedure was well tolerated with no significant adverse effects registered.

Predictive factors of clinical response in steroid-refractory ulcerative colitis treated with granulocyte-monocyte apheresis.

AIM: To identify factors predicting the clinical response of ulcerative colitis patients to granulocyte-monocyte apheresis (GMA). METHODS: Sixty-nine ulcerative colitis patients (39 F, 30 M) dependent upon/refractory to steroids were treated with GMA. Steroid dependency, clinical activity index (CAI), C reactive protein (CRP) level, erythrocyte sedimentation rate (ESR), values at baseline, use of immunosuppressant, duration of disease, and age and extent of disease were considered for statistical analysis as predictive factors of clinical response. Univariate and multivariate logistic regression models were used. RESULTS: In the univariate analysis, CAI (P = 0.039) and ESR (P = 0.017) levels at baseline were singled out as predictive of clinical remission. In the multivariate analysis steroid dependency [Odds ratio (OR) = 0.390, 95% Confidence interval (CI): 0.176-0.865, Wald 5.361, P = 0.0160] and low CAI levels at baseline (4 < CAI < 7) (OR = 0.770, 95% CI: 0.425-1.394, Wald 3.747, P = 0.028) proved to be effective as factors predicting clinical response. CONCLUSION: GMA may be a valid therapeutic option for steroid-dependent ulcerative colitis patients with mild-moderate disease and its clinical efficacy seems to persist for 12 mo.

Leukocytapheresis in the treatment of inflammatory bowel disease: Current position and perspectives.

Therapeutic apheresis, a novel approach for immunodisorders, has been used in the last decade for the treatment of ulcerative colitis with promising result, and represents an alternative to conventional pharmacological therapy. Selective apheresis is aimed at reducing the number of circulating lymphocytes, interfering with recruitment and activation of mucosal granulocytes and macrophages, reducing cytokine and chemokine production which are thought to contribute to induction and perpetuation of inflammation. The article briefly reports indications, treatment schedule and clinical results of leukocytapheresis in ulcerative colitis. Available data for the two selective adsorption devices so far approved for clinical use (granulocyte-monocyte apheresis- Adacolumn- and leukocytapheresis-Cellsorba) are partially conflicting, and the number of controlled studies too small to draw definitive conclusions. Nonetheless apheresis definitely appears to be an effective non-conventional tool for the treatment of steroid refractory and steroid dependent UC patients with moderately active disease. The excellent safety profile of the procedure makes this approach attractive, both in adult and in pediatric patients, more so in those refractory to conventional drug therapy, who are presently treated with immunosuppressive and biological therapies.

Cytomegalovirus infection in inflammatory bowel disease patients undergoing anti-TNFalpha therapy.

BACKGROUND: Cytomegalovirus infection and disease is associated with poor prognosis and steroid refractoriness in inflammatory bowel disease patients. The unfavourable effect of steroids and immunosuppressive therapy on CMV infection is well known but few data are available concerning anti-TNFalpha therapy (Infliximab). Aim of the study was to evaluate the presence and severity of CMV infection and disease in Infliximab-treated IBD patients. PATIENTS AND METHODS: The severity of active CMV infection and disease was assessed in 11 consecutive patients with ileocolonic/colonic disease and 4 patients with ulcerative colitis before and after a standard 3-infusion course of Infliximab. Active CMV infection was evaluated by serology and diagnosed by means of pp65-antigenemia (pp65 AG), and quantification of CMV DNA isolated from biopsy specimens of colonic tissue. CMV disease was assessed on haematoxylin/eosin-stained colonic biopsies and immunohistochemical stains. RESULTS: Of the 11 patients, nine were CMV seropositive. As far as concerns CMV infection, only one patient had positive pp65 AG, before and after Infliximab. CMV DNA was detected in the colonic biopsies of three patients. In 2, CMV DNA persisted also after therapy with 410 and 1300 copies/microg of DNA, respectively, albeit with no evidence of worsening of the colonic disease. In the remaining patient, CMV DNA load became undetectable. Conventional histology and immunohistochemical stains were negative for CMV in all the patients, without evidence of CMV disease. CONCLUSIONS: Active CMV infection did not progress to disease following Infliximab therapy. Although these preliminary observations require confirmation, the response to Infliximab therapy does not appear to be influenced by, or influence the course of, CMV infection/disease.