ABSTRACT Background This multicenter multinational RCT designed to compare the efficacy of suppository indomethacin and NAC for prevention of PEP. Methods: During a 6-month period, all of the ERCP cases in seven referral centers were randomly assigned to receive either 1200 mg oral NAC, indomethacin suppository 100 mg, 1200 mg oral NAC plus indomethacin suppository 100 mg or placebo 2 hours before ERCP. The primary outcomes were the rate and severity of any PEP. Results: A total of 432 patients included (41.4% male). They were originally citizens of 6 countries (60.87% Caucasian). They were randomly allocated to receive either NAC (group A, 84 cases), rectal indomethacin (group B, 138 cases), NAC + rectal indomethacin (group C, 115 cases) or placebo (group D, 95 cases). The rate of PEP in groups A, B and C in comparison with placebo were 10.7%, 17.4%, 7.8% vs 20% (P=0.08, 0.614 & 0.01 respectively). The NNT for NAC, indomethacin and NAC + indomethacin was 11, 38 and 8 respectively. Conclusion: Oral NAC is more effective than rectal indomethacin when compared to placebo for prevention of PEP and the combination of NAC and Indomethacin had the lowest incidence of PEP and may have synergistic effect in preventing of PEP (IRCT20201222049798N1; 29/12/2020). Methods 6month month period 120 10 Results 43 41.4% 414 41 4 (41.4 male. male . male) 60.87% 6087 60 87 (60.87 Caucasian. Caucasian Caucasian) group cases, , 13 11 D 9 cases. 107 7 10.7% 174 17 17.4% 78 7.8 20 P=0.08, P008 P 0 08 (P=0.08 0614 614 0.61 001 01 0.0 respectively respectively) 3 Conclusion IRCT20201222049798N1 IRCTN IRCT N (IRCT20201222049798N1 29/12/2020. 29122020 29/12/2020 29 12 2020 29/12/2020) 1 41.4 (41. 60.87 608 (60.8 10.7 17.4 7. P=0.08 P00 (P=0.0 061 61 0.6 00 0. IRCT20201222049798N (IRCT20201222049798N 2912202 29/12/202 202 41. (41 60.8 (60. 10. 17. P=0.0 P0 (P=0. 06 291220 29/12/20 (4 60. (60 P=0. (P=0 29122 29/12/2 ( (6 P=0 (P= 2912 29/12/ P= (P 291 29/12 29/1 29/

RESUMO Contexto: Este estudo randomizado, controlado multicêntrico e multinacional foi projetado para comparar a eficácia da indometacina supositório e N-acetil cisteína (NAC) para prevenção de pancreatite pós colangiografia endoscópica. Métodos: Durante um período de 6 meses, todos os pacientes submetidos à CPRE em sete centros de referência foram aleatoriamente atribuídos para receber 1200 mg de NAC oral, supositório de indometacina 100 mg, 1200 mg de NAC oral mais supositório de indometacina 100 mg ou placebo 2 horas antes do procedimento. Os resultados primários foram a taxa e a gravidade de qualquer pancreatite pós procedimento (PPP). Resultados: Um total de 432 pacientes foram incluídos (41,4% do sexo masculino). Eram originalmente cidadãos de seis países (60,87% caucasianos). Foram alocados aleatoriamente para receber NAC (grupo A, 84 casos), indometacina retal (grupo B, 138 casos), NAC + indometacina retal (grupo C, 115 casos) ou placebo (grupo D, 95 casos). A taxa de PPP nos grupos A, B e C em comparação com o placebo foi de 10,7%, 17,4%, 7,8% vs 20% (P=0,08, 0,614 e 0,01, respectivamente). Conclusão A NAC oral é mais eficaz do que a indometacina retal quando comparado ao placebo para prevenção de PPP e a combinação de NAC e indometacina teve a menor incidência de PPP e pode ter efeito sinérgico na sua prevenção de PPP. (IRCT20201222049798N1; 29/12/2020). Contexto randomizado Nacetil N acetil (NAC endoscópica Métodos meses 120 10 . (PPP) Resultados 43 41,4% 414 41 4 (41,4 masculino. masculino masculino) 60,87% 6087 60 87 (60,87 caucasianos. caucasianos caucasianos) grupo 8 casos, casos , 13 11 D 9 casos. 107 7 10,7% 174 17 17,4% 78 7,8 20 P=0,08, P008 P 0 08 (P=0,08 0614 614 0,61 001 01 0,01 respectivamente. respectivamente respectivamente) IRCT20201222049798N1 IRCTN IRCT (IRCT20201222049798N1 29/12/2020. 29122020 29/12/2020 29 12 2020 29/12/2020) 1 (PPP 41,4 (41, 60,87 608 (60,8 10,7 17,4 7, P=0,08 P00 (P=0,0 061 61 0,6 00 0,0 IRCT20201222049798N (IRCT20201222049798N 2912202 29/12/202 202 41, (41 60,8 (60, 10, 17, P=0,0 P0 (P=0, 06 0, 291220 29/12/20 (4 60, (60 P=0, (P=0 29122 29/12/2 ( (6 P=0 (P= 2912 29/12/ P= (P 291 29/12 29/1 29/

RESUMO Contexto: O papel dos alimentos lácteos na doença inflamatória intestinal (DII) tem sido controverso e é discutível se os pacientes com DII devem ou não evitar leite e laticínios, bem como a relação entre esses alimentos e sintomas nesta população. Objetivo: Estudo transversal multicêntrico foi projetado para avaliar se é realmente necessário privar os pacientes com DII do consumo desta classe de alimentos. Métodos: Um estudo multicêntrico com 12 centros de referência em gastroenterologia de quatro países foi projetado para avaliar sintomas gastrointestinais após o consumo de alimentos lácteos em todos os ambulatórios de DII durante seis meses e comparar pacientes tratados nos mesmos centros sem DII. Resultados: No total, foram incluídos 1888 casos (872 pacientes com DII e 1016 casos sem DII. 56,6% dos participantes eram do sexo feminino com idade média de 40,1 anos. 79,8% dos participantes eram caucasianos e originalmente eram cidadãos de 10 países. A prevalência relativa de DII foi maior em africanos e indianos e a prevalência mais frequente de intolerância a alimentos lácteos observada nos asiáticos. Entre os pacientes com DII, 571 casos foram diagnosticados como colite ulcerativa e 189 participantes como doença de Crohn. A duração média do diagnóstico como DII foi de 6,8 anos (de 2 meses a 35 anos). Os sintomas de gastrointestinais mais prevalentes após o consumo de todos os alimentos lácteos foram inchaço e dor abdominal. No total, a intolerância aos alimentos lácteos e a deficiência de lactase foi mais prevalente entre os pacientes com DII em comparação com os casos sem DII (65,5% vs 46,1%, P=0,0001). A taxa de queixas gastrointestinais entre os pacientes com DII que não tinham histórico familiar de deficiência de lactase, histórico de sensibilidade alimentar ou ambos foram de 59,91%, 52,87% e 50,33% respectivamente e semelhantes aos casos sem DII (P=0,68, 0,98 e 0,99, respectivamente). Conclusão: A taxa de intolerância de alimentos lácteos entre pacientes com DII sem histórico familiar de deficiência de lactase ou histórico de sensibilidade alimentar é semelhante aos casos sem DII e provavelmente não há razão para privá-los dessa importante fonte de cálcio dietético, vitamina D e outros nutrientes.

ABSTRACT Background: The role of dairy foods in inflammatory bowel disease (IBD) has been controversial and it is debatable if patients with IBD should avoid milk and dairy products or not, as well as the relationship between these foods and symptoms among those population. Objective: This multi centric cross-sectional study designed to evaluate if it is really necessary to deprive IBD patients from consumption of dairy foods. Methods: A multicenter study with 12 gastroenterology referral centers in four countries was designed to evaluate gastrointestinal (GI) symptoms after consumption of dairy foods from all outpatients with IBD during 6 months and to compare patients treated at the same centers without IBD (non IBD cases). Results: Overall 1888 cases included (872 IBD patients and 1016 non IBD cases). 56.6% of participants were female with average age of 40.1 years. Racially 79.8% participants were Caucasians and originally they were citizens of 10 countries. Relative prevalence of IBD was higher in Africans and Indians and the most frequent prevalence of dairy foods intolerance was seen in Asians. Among IBD patients, 571 cases diagnosed as ulcerative colitis and 189 participants as Crohn’s disease. Average duration of diagnosis as IBD was 6.8 years (from 2 months to 35 years). The most prevalent GI symptoms after consumption of all the dairy foods were bloating and abdominal pain. Totally, intolerance of dairy foods and lactase deficiency was more prevalent among IBD patients in comparison with non IBD cases (65.5% vs 46.1%, P=0.0001). But the rate of GI complains among IBD patients who had not any family history of lactase deficiency, history of food sensitivity or both were 59.91%, 52.87% & 50.33% respectively and similar to non IBD cases (P=0.68, 0.98 & 0.99 respectively). Conclusion: The rate of dairy foods intolerance among IBD patients without family history of lactase deficiency or history of food sensitivity is similar to non IBD cases and probably there is no reason to deprive them from this important source of dietary calcium, vitamin D and other nutrients.

Abstract Background Organic colonic manifestation may be difficult to be differentiated from functional one. Inflammatory bowel disease (IBD) is a common chronic inflammatory and destructive disease of the bowel wall. Chronic inflammation is associated with ulcerations, strictures, perforations, and it is a risk factor for dysplasia and cancer. To reduce these long-standing complications, IBD patients are in a continuous need for early diagnosis1. Markers, such as erythrocyte sedimentation rate (ESR), and c-reactive protein (CRP), fecal calprotectin (FC) have been widely used as noninvasive parameters for IBD monitoring. We aimed, in this current study, to evaluate the value of fecal calprotectin and other noninvasive biomarkers in predicting abnormal histologic findings in patients undergoing colonoscopy.in addition to determine the cutoff value which predict IBD2. Methods The present prospective study included 160 patients with complaint of colicky abdominal pain with frequent diarrhea associated with mucous and infrequent bleeding per rectum for more than 6 months. They presented partial improvement with medication and recurrence once stopping the treatment These patients had been recently diagnosed with IBD at many primary healthcare centers covering the areas of the Kafrelsheikh and Zagazik governorate in the North of Egyptian Nile delta. After complete history, clinical examination, and laboratory investigation, they were referred to the IBD clinic at Kafrelsheikh University Hospital for assessment and ileocolonoscopy with biopsies. Results There was a wide spectrum of age of the studied patients, with mean age 40.12±7.88 (minimum 18 and maximum 56 years). Regarding gender, males represented 87.5% of the studied patients. Forty percent of the patients with colonic manifestation were smokers, 57% preferred a spicy diet, and the majority had low educational level (77.5%). Forty percent had obvious blood in stool, 55% had occult blood, and raised ESR CRP occurred in 32.5% and 50%, respectively. Fecal calprotectin cutoff was>159, with sensitivity 92.8% and specificity 97.5%. Conclusions: Biomarkers (FC, ESR, CRP) can be used as noninvasive parameters for the early diagnosis and prediction of organic colonic disease. Fecal calprotectin in the IBD group revealed significant area under the curve (AUC) values and cutoff>159, with sensitivity 92.8% and specificity 97.5%.

RESUMO Contexto: Este estudo randomizado, controlado multicêntrico e multinacional foi projetado para comparar a eficácia da indometacina supositório e N-acetil cisteína (NAC) para prevenção de pancreatite pós colangiografia endoscópica. Métodos: Durante um período de 6 meses, todos os pacientes submetidos à CPRE em sete centros de referência foram aleatoriamente atribuídos para receber 1200 mg de NAC oral, supositório de indometacina 100 mg, 1200 mg de NAC oral mais supositório de indometacina 100 mg ou placebo 2 horas antes do procedimento. Os resultados primários foram a taxa e a gravidade de qualquer pancreatite pós procedimento (PPP). Resultados: Um total de 432 pacientes foram incluídos (41,4% do sexo masculino). Eram originalmente cidadãos de seis países (60,87% caucasianos). Foram alocados aleatoriamente para receber NAC (grupo A, 84 casos), indometacina retal (grupo B, 138 casos), NAC + indometacina retal (grupo C, 115 casos) ou placebo (grupo D, 95 casos). A taxa de PPP nos grupos A, B e C em comparação com o placebo foi de 10,7%, 17,4%, 7,8% vs 20% (P=0,08, 0,614 e 0,01, respectivamente). Conclusão A NAC oral é mais eficaz do que a indometacina retal quando comparado ao placebo para prevenção de PPP e a combinação de NAC e indometacina teve a menor incidência de PPP e pode ter efeito sinérgico na sua prevenção de PPP. (IRCT20201222049798N1; 29/12/2020).

ABSTRACT Background This multicenter multinational RCT designed to compare the efficacy of suppository indomethacin and NAC for prevention of PEP. Methods: During a 6-month period, all of the ERCP cases in seven referral centers were randomly assigned to receive either 1200 mg oral NAC, indomethacin suppository 100 mg, 1200 mg oral NAC plus indomethacin suppository 100 mg or placebo 2 hours before ERCP. The primary outcomes were the rate and severity of any PEP. Results: A total of 432 patients included (41.4% male). They were originally citizens of 6 countries (60.87% Caucasian). They were randomly allocated to receive either NAC (group A, 84 cases), rectal indomethacin (group B, 138 cases), NAC + rectal indomethacin (group C, 115 cases) or placebo (group D, 95 cases). The rate of PEP in groups A, B and C in comparison with placebo were 10.7%, 17.4%, 7.8% vs 20% (P=0.08, 0.614 & 0.01 respectively). The NNT for NAC, indomethacin and NAC + indomethacin was 11, 38 and 8 respectively. Conclusion: Oral NAC is more effective than rectal indomethacin when compared to placebo for prevention of PEP and the combination of NAC and Indomethacin had the lowest incidence of PEP and may have synergistic effect in preventing of PEP (IRCT20201222049798N1; 29/12/2020).

Abstract Coronavirus disease 2019 (COVID-19) is highly transmittable through contact with respiratory droplets. The virus is also shed in fecal matter. Some patients may present with effects in more than one system; however, there are no defined biomarkers that can accurately predict the course or progression of the disease. The present study aimed to estimate the severity of the disease, to correlate the severity of the disease with biochemical predictors, to identify valuable biomarkers indicative of gastrointestinal disease, and to determine the cutoff values. A cross-sectional study was conducted on COVID-19 patients admitted to the Kafrelsheikh University Hospital (isolation unit) between July 10, 2020, and October 30, 2020. The diagnosis of COVID- 19 was confirmed via reverse transcription-polymerase chain reaction (RT-PCR), which was employed for the detection of the viral RNA. We conclude that lymphopenia, elevated C-reactive protein (CRP) level, and liver enzymes were among the most important laboratory findings in COVID-19 patients. Statistically significant differences in platelet count, neutrophil count, D-dimer level, and fecal calprotectin levels were observed among patients presenting with chest symptoms only and patients with both chest and gastrointestinal symptoms (p=0.004;<0.001; 0.010; 0.003; and<0.001, respectively). C-reactive protein, D-dimer, and fecal calprotectin levels positively correlated with disease severity. The cutoff value for fecal calprotectin that can predict gastrointestinal involvement in COVID-19 was 165.0, with a sensitivity of 88.1% and a specificity of 76.5%.

Resumo Introdução As manifestações da doença inflamatória intestinal (DII) não se restringem ao trato gastrointestinal. Distúrbios musculoesqueléticos são considerados as manifestações extraintestinais mais comuns, seguidos de doenças oculares e mucocutâneas. Muitos clínicos gerais desconhecem a variedade e a severidade das afecções oculares em casos de DII. Objetivo Determinar a prevalência das manifestações extraintestinais em pacientes com DII na província de Kafrelsheikh, no Egito, e avaliar as diferentes manifestações oculares e sua relação com a gravidade da doença. Métodos Um estudo transversal que avaliou 120 pacientes tratados no Kafrelsheikh University Hospital. O diagnóstico de DII foi feito entre dezembro de 2018 e dezembro de 2019 por meio de exames clínicos, endoscópicos e histopatológicos. Por meio de exames de lâmpada de fenda, tonometria, acuidade visual, e oftalmoscopia indireta, todos os pacientes foram avaliados para se determinar a ocorrência de quaisquer manifestações extraintestinais ou afecções oculares. Resultados Amédia de idade da amostra foi de 35,5 ± 13,3 anos. No total, 52 (43,3%) pacientes com DII eram do sexo masculino, e 68 (56,7%), do sexo feminino. As manifestações oculares representaram ~ 22,5% das manifestações extraintestinais. Os achados oculares mais comuns foram conjuntivite (25,8%) e uveíte anterior (10,8%), seguidas de esclerite (9,2%) e catarata (8,3%). Outras manifestações extraintestinais foram observadas em 41 (34,1%) pacientes, entre elas, 29,9% de casos de colite ulcerativa, e 52% de casos de doença de Crohn. Não houve diferença estatisticamente significativa na presença de envolvimento ocular com relação aos dois tipos de DII descritos na classificação de Montreal. Conclusão Asmanifestações oculares empacientes de DII são comuns e, geralmente, não específicas em termos de apresentação. A gravidade da DII não reflete a gravidade da afecção ocular.

Abstract Introduction The manifestations of inflammatory bowel disease (IBD) are not restricted to the gastrointestinal tract. Musculoskeletal conditions are considered the most common extraintestinal manifestations, followed by mucocutaneous and ocular diseases. Many general practitioners are unaware of the variety and severity of the ocular affection in IBD patients. Objective To assess the prevalence of extraintestinal manifestations in IBD patients at Kafrelsheikh governorate, and to evaluate the different ocularmanifestations and their relationship to the severity of the disease. Methods A cross-sectional study evaluating 120 patients treated at the Kafrelsheikh University Hospital. The diagnosis of IBD was made between December 2018 and December 2019 through clinical, endoscopic and histopathological examinations. All patients were assessed for any extraintestinal manifestation or evidence of ocular affection through slit-lamp examinations, tonometry, visual acuity, and indirect ophthalmoscopy. Results The mean age of the sample was 35.5 ± 13.3 years. In total, 52 (43.3%) patients were male and 68 (56.7%) were female. Ocular manifestations represent ~ 22.5% of extraintestinal manifestations. The most common ocular findings were conjunctivitis (25.8%) and anterior uveitis (10.8%), followed by scleritis (9.2%) and cataract (8.3%). Other extraintestinal manifestations were observed in 41 (34.1%) 29 (29.9%) of ulcerative colitis cases, and 12 (52%) of Crohn disease cases. There was no statistically significant difference in the presence of ocular involvement in relation to the two types of IBD included in the Montreal classification. Conclusion Ocular manifestations in cases of IBD are common and usually nonspecific in presentation. The severity of the IBD does not reflect the severity of the ocular affection.