Inflammatory bowel disease meets fertility: A physician and patient survey.

BACKGROUND AND AIMS: Inflammatory bowel disease (IBD) can affect patients during their childbearing years. Literature evidence is scarce regarding the level of knowledge among health care professionals (HCPs) and patients about the impact of IBD on fertility. The aim of this survey was to investigate HCPs' and patients' knowledge on fertility, pregnancy, and sexual function, to evaluate how HCPs approach this topic and to report patients' reproductive outcomes. METHODS: Subjects were invited to anonymously complete an online questionnaire collecting data on demographics, patients' disease characteristics, Crohn's and colitis pregnancy-specific disease-related knowledge (CCPKnow), family planning, reason of childlessness, pregnancy outcomes, need for assisted reproductive technology, impact on sexual function, and availability of patients' information regarding IBD and pregnancy. RESULTS: A total of 257 HCPs from 40 countries and 793 patients (615 females, 176 males and 2 who preferred not to disclose their gender; 396 (50%) with ulcerative colitis, 381 (48%) with Crohn's disease, 14 (1.8%) with undetermined IBD) from 4 countries completed the survey. In total, 98.4% of HCPs had good or very good pregnancy-specific knowledge according to CCPKnow score, compared to only 29.3% of patients. Of the women surveyed, 56.3% had no children (14.1% due to a voluntary choice). A total of 427 pregnancies and 401 live births were reported in 266 women. Twenty-four pregnancies (5.6%) in 22 women required assisted reproductive technologies (ART). There were no more complications in pregnancies resulting from ART compared with spontaneous conception (5/24; 20.8% vs 81/401; 20.2%). Three quarters of IBD patients (75.6%) had breastfed. An impaired sexual function was found in one-fifth (21.9%) of men with IBD, while two-thirds (66.1%) of the women reported sexual function impairment. Surprisingly, 63% of patients reported not having received any information about IBD and pregnancy, and only 10% of patients had received information from their IBD specialist. In addition, 42.1% and 36% of HCPs had already referred a patients to a medically assisted reproduction center to receive general information about their reproductive health and about options of fertility preservation (e.g., cryopreservation), respectively. CONCLUSION: IBD patients have a poor knowledge about the impact of IBD on fertility and pregnancy and HCPs do not sufficiently inform their patients. More information on these topics is needed for IBD patients.

C3435T Polymorphism of the ABCB1 Gene in Polish Patients with Inflammatory Bowel Disease: A Case-Control and Meta-Analysis Study.

P-glycoprotein encoded by the ABCB1 gene constitutes a molecular barrier in the small and large bowel epithelium, and its different expression may influence susceptibility to inflammatory bowel disease (IBD). We aimed to assess the contribution of the C3435T polymorphism to disease risk in the Polish population. A total of 100 patients (50 Crohn's disease (CD), 50 ulcerative colitis (UC)) and 100 healthy controls were genotyped for the single nucleotide polymorphism (SNP) C3435T by using the PCR-RFLP method. Patients were classified on the basis of disease phenotype and the specific treatment used. A meta-analysis was carried out of our results and those from previously published Polish studies. There was no significant difference in allele and genotype frequencies in IBD patients compared with controls. For CD patients, a lower frequency of TT genotype in those with colonic disease, a lower frequency of T allele, and a higher frequency of C allele in those with luminal disease were observed, whereas for UC patients, a lower frequency of CT genotype was observed in those with left-sided colitis. A meta-analysis showed a tendency towards higher prevalence of CC genotype in UC cases. These results indicate that the C3435T variants may confer a risk for UC and influence disease behaviour.

Randomized Controlled Trial: Subcutaneous vs Intravenous Infliximab CT-P13 Maintenance in Inflammatory Bowel Disease.

BACKGROUND & AIMS: This study compared pharmacokinetics, symptomatic and endoscopic efficacy, safety, and immunogenicity of a subcutaneous formulation of the infliximab biosimilar CT-P13 (CT-P13 SC) vs intravenous CT-P13 (CT-P13 IV) in patients with inflammatory bowel disease (IBD). METHODS: This randomized, multicenter, open-label, parallel-group, phase 1 study enrolled tumor necrosis factor inhibitor-naïve patients with active ulcerative colitis (total Mayo score 6-12 points with endoscopic subscore ≥2) or Crohn's disease (Crohn's Disease Activity Index 220-450 points) at 50 centers. After CT-P13 IV induction at Week (W) 0/W2, patients were randomized (1:1) to receive CT-P13 SC every 2 weeks (q2w) from W6 to W54 or CT-P13 IV every 8 weeks from W6 to W22. At W30, all patients receiving CT-P13 IV switched to CT-P13 SC q2w until W54. The primary endpoint was noninferiority of CT-P13 SC to CT-P13 IV for observed predose CT-P13 concentration at W22 (Ctrough,W22), concluded if the lower bound of the 2-sided 90% confidence interval (CI) for the ratio of geometric least-squares means exceeded 80%. RESULTS: Overall, 66 and 65 patients were randomized to CT-P13 SC and CT-P13 IV, respectively. The primary endpoint of noninferiority was met with a geometric least-squares means ratio for Ctrough,W22 of 1154.17% (90% CI 786.37-1694.00; n = 59 [CT-P13 SC]; n = 57 [CT-P13 IV]). W30/W54 clinical remission rates were comparable between arms. Other efficacy, safety, and immunogenicity assessments were also broadly comparable between arms, including after switching. CONCLUSIONS: The pharmacokinetic noninferiority of CT-P13 SC to CT-P13 IV, and the comparable efficacy, safety, and immunogenicity profiles, support the potential suitability of CT-P13 SC treatment in IBD. ClinicalTrials.gov ID: NCT02883452.

Diabetic autonomic neuropathy of the gastrointestinal tract.

Diabetes is a metabolic disease leading to the development of numerous health complications. In developed countries, it is the main cause of blindness, end-stage renal disease, and non-traumatic amputation of the lower limbs. Neuropathy is the most common chronic complication of diabetes. A long-term course of a metabolically unbalanced disease causing damage to the autonomic nervous system of the digestive tract results in the development of many complications, such as intensification of gastro-oesophageal reflux disease, gastroparesis, chronic diarrhoea or faecal incontinence.

13C-Methacetin Breath Testing in Patients with Non-Alcoholic Fatty Liver Disease.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is a very common chronic liver condition which may potentially develop into fibrosis and cirrhosis. Liver biopsy is still the gold standard for liver fibrosis detection in these patients. However, non-invasive tools for liver assessment in NAFLD patients, like the (13)C-methacetin breath test, may be useful. OBJECTIVES: The aim of the study was to evaluate the utility of the (13)C-methacetin breath test in NAFLD patients, especially in predicting significant fibrosis. MATERIAL AND METHODS: Thirty three patients (24 male and 9 female (average age 47.9)) with histologically proven NAFLD had the (13)C-methacetin breath test performed. RESULTS: Different forms of NAFLD were found during the histology phase, from simple steatosis to advanced fibrosis. Simple steatosis (SS) was found in 18 subjects (54.5%), in another 15 (45.5%) signs of inflammation and fibrosis (NASH) were observed. However, more than half of the patients with liver fibrosis had only minimal changes described (0/1). The sensitivity of the test was highest for cumulative recovery after 10 min of the test and for a combination of two parameters (the cumulative recovery after 40 min and the time of maximal momentary recovery). The positive predictive value was low for all the parameters under consideration, but the negative predictive value was over 0.8 in significant fibrosis detection. CONCLUSIONS: The (13)C-methacetin breath test could be a promising noninvasive tool for excluding at least F1 fibrosis in NAFLD patients.

[Tetany as a frequent cause of an emergency consultations--etiology, symptoms and cure]. / Tezyczka jako czesta przyczyna konsultacji na ostrym dyzurze--etiologia, objawy chorobowe i leczenie.

Tetany is a disorder with a very heterogeneous clinical manifestation. It includes neuromuscular hyperactivity, decreased attention, fatigue, constant anxiety. Attacks of tetany range from mild symptoms, which includes circumoral and distal paresthesias, hyperventilation, accompanied by shortness of breath, palpitation, dizziness, nausea and carpopedal spasm, through more severe symptoms like generalized seizures, loss of consciousness, muscle crumps to life-threatening emergencies like laryngospasm or arrhythmias. Tetany can be a result of many electrolyte disturbances, like hypocalcaemia, hypomagnesemia, hypokalaemia, alkalosis and electrolyte disturbances following hyperventilation. These disorders may occur in many clinical situations including diet deficiencies, alcoholism, endocrine diseases, genetic disorders, iatrogenic causes like proton pump inhibitors therapy and many, many others. It happens that tetany is diagnosed too late and therefore insufficiently cured. For these reason it deserves closer attention.

Hepcidin and its role in inflammatory bowel disease.

Anemia is one of the most common extraintestinal symptoms of inflammatory bowel disease (IBD). The pathophysiology of anemia in IBD is complex. It may be developed in the course of inflammation, intestinal bleeding or disorders of iron absorption. Hepcidin, discovered in the year 2000, is an endogenous peptide responsible for iron homeostasis. Recent data suggests that hepcidin is a major mediator of anemia and plays a central role in iron homeostasis and metabolism. This paper presents information about hepcidin structure and function, mechanisms of the regulation of the synthesis and current data about the role of this hormone in IBD-related anemia. Assessment of hepcidin levels in patients with IBD may become a key element in the treatment of anemia in the near future.