Levofloxacin+Tetracycline Quadruple Regimen for Eradication of Helicobacter pylori: A Multicenter Multinational Randomized Controlled Trial.

Background: The ideal combination regimen for Helicobacter pylori (HP) eradication has not yet been determined and the success rate of HP eradication has been extensively reduced worldwide due to increasing antibiotic resistance. So this multinational multi-center randomized controlled trial was designed to evaluate the efficacy of tetracycline +levofloxacin for HP eradication. Methods: During a 6-month period, all of the cases with HP infection in eight referral tertiary centers of three countries were included and randomly allocated to receive either tetracycline + levofloxacin or clarithromycin plus amoxicillin quadruple regimen for two weeks. For all of the participants, pantoprazole was continued for 4 more weeks and after one to two weeks of off-therapy, they underwent urea breath test C13 to prove eradication. Results: Overall 788 patients were included (358 male (45.4%), average age 44.2 years). They were diagnosed as having non-ulcer dyspepsia (516 cases, 65.5%), peptic ulcer disease (PUD) (234 cases, 29.69%), and intestinal metaplasia (38 cases, 4.8%). Racially 63.1% were Caucasian, 14.5% Arab, 15.6% African, and 6.1% Asian. The participants were randomly allocated to groups A and B to receive either tetracycline + levofloxacin or clarithromycin. Among groups A and B in intention to treat (ITT) and per protocol (PP) analysis, 75.2% & 82.1% (285 cases) and 67.5% & 70.1% (276 cases) of participants achieved eradication, respectively (P = 0.0001). The complete compliance rate in groups A and B were 84.4% and 83.6%, respectively. During the study, 33.5% of the participants in group A (127 cases) reported side effects while the complication rate among group B was 27.9% (114 cases, P = 0.041). The most common complaints among groups A and B were nausea and vomiting (12.6% & 9.3%) and abdominal pain (4.48% & 2.68%), respectively. The rate of severe complications that caused discontinuation of medication in groups A and B were 2.1% and 1.46%, respectively (P = 679). In subgroup analysis, the eradication rates of tetracycline+levofloxacin among patients with non-ulcer dyspepsia, PUD, and intestinal metaplasia were 79.4%, 88.1%, and 73.9%, respectively. These figures in group B (clarithromycin base) were 71.3%, 67.6%, and 61.5% respectively (P = 0.0001, 0.0001, and 0.043). Conclusion: Overall, the combination of tetracycline+levofloxacin is more efficient for HP eradication in comparison with clarithromycin+amoxicillin despite more complication rate. In areas with a high rate of resistance to clarithromycin, this therapeutic regimen could be an ideal choice for HP eradication, especially among those who were diagnosed with PUD.

Effect of Helicobacter pylori eradication on metabolic profile: an international, multicenter, case-control study.

BACKGROUND: As a gram-negative and microaerophilic bacterium, Helicobacter pylori (HP) is the main cause of chronic gastritis. Therefore, considering the high prevalence of HP infection worldwide, as well as the increasing prevalence of metabolic disorders, the present study aimed to investigate the relationship between HP infection eradication and metabolic profile. METHODS: This prospective case-control study was performed on patients with HP infection whom referred to 7 medical centers in 3 countries (Iran, Egypt, and Vietnam) in 2020-2021. The metabolic profile of all of the participants evaluated before starting of treatment for HP eradication and 3 months after the treatment. Then changes of metabolic profile compared between those with successful HP eradication (group A) and subjects who failed to eradicate (group B). RESULTS: Overall, 199 patients, including 93 male (46.7%) with the mean age of 44.5 years (18-93 years) included. Based on response to treatment, the participants allocate into group A (those who respond to HP eradication): 164 cases (82.42%); or group B as those who failed to achieve eradication (35 cases, 17.58%). Racially 86.9% of participants were Caucasian and 89% diagnosed as non-ulcer dyspepsia (NUD). The most prevalent comorbidity include hypertension (11.5%) and hyperlipidemia (10%) which were more prevalent in group B (P = 0.002). Three months after therapy, average weight of participants among those who achieved eradication (group A) decreased from 73.1 to 71.4 kg (P = 0.01), but in comparison with group B, was non-significant (P = 0.171). The BMI of patients before and after treatment did not show any significant differences. The biochemical parameters of patients before and after treatment were not significantly different regardless of treatment success (P > 0.05). The levels of total cholesterol and VLDL cholesterol after treatment were not significantly different from baseline values in two groups. HDL and LDL cholesterol levels before and after treatment in the resistant group were significantly higher than the responding group. Average serum TG level decreased significantly after treatment in the group A (P < 0.0001), in contrast to the resistant group (P = 0.356). The liver transaminases (AST and ALT) before and after treatment were not significantly different between the two groups (P > 0.05). The results of logistic regression showed that the eradication of infection has no significant affect any of the metabolic profile parameters. CONCLUSION: HP infection treatment in individuals without significant metabolic disorders does not affect metabolic parameters up to 3 months after eradication. HP eradication among subjects with several comorbidities mandates eradication protocol intensification to avoid treatment failure.

Association between high-sensitivity-CRP and liver elastography and cardiac ischemic diseases in patients with fatty liver.

Objective: Inflammatory markers are among the possible contributing factors with a proposed role in hepatic and ischemic heart disease. The present study aimed to determine the association between high-sensitivity-C-reactive protein (hs-CRP), liver elastography, and cardiac ischemic diseases in patients with fatty liver. Methods: In this cross-sectional comparative study, 103 consecutive patients with fatty liver were enrolled to undergo angiography. They were divided into groups with and without cardiac ischemia. Results: The results demonstrated that the mean hs-CRP was 2.3 and 10.9 mg/L in normal and ischemic angiography groups, respectively (P = 0.001). According to the receiver operating characteristic (ROC) analysis, the predictive role for hs-CRP was 94.5% that had sensitivity and specificity of 95.2% and 90%, respectively, with a cut-off point of 3.1. Conclusion: This study showed that there is an association between the fatty liver, cardiac ischemia, and hs-CRP level.

IS DAIRY FOODS RESTRICTION MANDATORY FOR INFLAMMATORY BOWEL DISEASE PATIENTS: A MULTINATIONAL CROSS-SECTIONAL STUDY.

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.

A restrição de alimentos lácteos é obrigatória para pacientes com doença inflamatória intestinal? Estudo transversal multinacional / Is dairy foods restriction mandatory for inflammatory bowel disease patients: a multinational cross-sectional study

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.

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.

Relationship Between Vitamin D Deficiency and Disease Activity in Patients with Inflammatory Bowel Disease in Ahvaz, Iran.

BACKGROUND AND AIMS: Previous studies have shown that vitamin D plays an important role in inflammatory bowel disease (IBD). This study was designed to investigate the relationship between vitamin D levels and disease activity in IBD patients in Ahvaz, Iran. METHODS: This cross-sectional study was conducted on adult IBD patients referring to the outpatient clinic of gastroenterology at Imam Khomeini Hospital in Ahvaz city, in the southwest of Iran. Each patient's disease activity defined according to Crohn's disease activity index (CDAI) in Crohn's disease (CD) and Truelove score in ulcerative colitis (UC) patients, serum 25[OH]D was measured using the radioimmunoassay method. Vitamin D deficiency was defined as concentration of <20 nmol/L. RESULTS: Studied subjects were 130 UC and 23 CD patients (62.1% females) with a mean age of 37.5 ± 12.35 years. Vitamin D deficiency was present in 99 (64.7%) IBD patients. Fifty-three patients (34.6%) had active disease who, compared with patients in remission, had more frequent low vitamin D levels (80 vs 56.7%, P = 0.017). In UC patients, disease activity was significantly associated with vitamin D deficiency (P = 0.035), but no such relationship was observed in CD patients (P = 0.74). CONCLUSION: Vitamin D deficiency was significantly associated with disease activity in IBD, especially in UC patients. Therefore, careful monitoring of vitamin D deficiency in these patients is highly recommended. Prospective cohort studies are also needed to determine the role of vitamin D deficiency and its treatment in the clinical course of IBD.

Esophageal Ulcer Due to Ectopic Pancreatic Tissue: A Case Report.

Heterotopic pancreatic tissue, known as pancreatic rest, is a pancreatic tissue that lacks anatomic and vascular continuity with the main body of the pancreas. Common locations for this tissue include the stomach, duodenum, jejunum, Meckel diverticulum, and ileum. In this report, we present a case of a patient whose pancreatic rest was diagnosed primarily during the investigation of dysphagia with solid foods and it was located in the mid esophagus as an unusual location.

Efficacy of Zinc Sulfate in Peptic Ulcer Disease: A Randomized Double-Blind Clinical Trial Study.

INTRODUCTION: Peptic ulcer is a common disease that affects millions of people worldwide. Considering its global prevalence finding new approach for treating is important. AIM: The aim of this study was to investigate the effect of zinc sulfate on gastric and duodenal ulcer treatment. MATERIALS AND METHODS: This double-blind clinical trial study was done on 90 patients who were admitted to the gastrointestinal endoscopy clinic of Tohid hospital in Sanandaj, Iran. All patients were diagnosed with gastric and duodenal ulcers. They were randomly divided into two-intervention and control groups, using block randomization with block sizes of 4. Patients and researcher were unaware of the grouping. To assess the level of zinc, blood samples were taken. In case of positive Rapid Urease Test (RUT), triple therapy regimen including amoxicillin, clarithromycin and omeprazole was administered for two weeks. For intervention group in addition to "triple therapy", an oral dose of Zinc Sulfate 220mg capsules were administered daily, while the control group received placebo capsules. RESULTS: A total of 54.5% and 57% of the patients in the intervention and control groups had gastric ulcer respectively. The Rapid Urease Test (RUT) result of 72.7% of intervention group and 83.3% of control group was positive (p = 0.24). Serum zinc level of 20.9% of intervention group and 35.7% of control group was lower than the normal level (p = 0.13). The mean of serum zinc level of intervention group and control group were 81.9 and 78.9 mg dL respectively (p = 0.4). After intervention, peptic ulcer in 81.8% of the intervention group and 83.3% of the control groups were improved (p= 0.85). Response to treatment were higher in patients with normal zinc levels compared to patients with abnormal levels (77.5% vs. 22.5%, p=0.019). CONCLUSION: A daily dose of 220mg zinc sulfate was not significantly effective on peptic ulcer. However, patients with normal zinc levels had better ulcer treatment.

Comparison of Vaginal and Oral Doses of Misoprostol for Labour Induction in Post-Term Pregnancies.

INTRODUCTION: Considering maternal complications, it is preferred to induce labour after 40 weeks. Labour induction is a procedure used to stimulate uterine contractions during pregnancy before the beginning of the labour. AIM: The aim of this study was to compare oral misoprostol with vaginal misoprostol for induction of labour in post-term pregnancies. MATERIALS AND METHODS: This double blind clinical-trial study was performed on 180 post-term pregnant women who were admitted to the labour ward of Besat Hospital Sanandaj, Iran in 2013-2014. Participants were equally divided into three groups using block randomization method. The induction was performed for the first group with 100 µg of oral misoprostol, for the second group with 50 µg of oral misoprostol, and for the third group with 25 µg of vaginal misoprostol. Vaginal examination and FHR was done before repeating each dose to determine Bishop Score. Induction time with misoprostol to the start of uterine contractions, induction time to delivery, and mode of delivery, systolic tachycardia, hyper stimulation and fetal outcomes were studied as well. RESULTS: First minute Apgar scores and medication dosage of the study groups were significantly different (p=0.0001). But labour induction, induction frequency, mode of delivery, complications, and 5 minutes Apgar score in the groups had no significant difference (p>0.05). The risk of fetal distress and neonatal hospitalization of the groups were statistically significant (p=0. 02). There was no significant difference between the three groups in terms of mean time interval from the administration of misoprostol to the start of uterine contractions (labour induction), the time interval from the start of uterine contractions to delivery and taking misoprostol to delivery. From the administration of misoprostol to start of the uterine contractions the mean difference between time intervals in the three groups were not statistically significant. CONCLUSION: Based on our findings it can be concluded that prescribing 100µg oral misoprostol is effective than 50 µg oral or 25 µg vaginal misoprostol in terms of induction time, maternal and neonatal outcomes in post- term pregnancy. However, the best dose and route should be decided according to evidence based information.