EFFECT OF POLYETHYLENE GLYCOL TREATMENT ON INTESTINAL INFLAMMATION ASSOCIATED WITH CYSTIC FIBROSIS IN CHILDREN - MUCOLAX

CHU de Bordeaux0 个研究点目标入组 23 人开始时间: 2020年6月4日最近更新: 2020年6月8日

适应症

试验速览

暂无简介。

•- Age = 4 years old and <18 years old ;
•- Patient with cystic fibrosis (sweat test > 60 mmol/l and/or molecular biology identifying mutations in the CFTR gene) with associated pancreatic insufficiency (fecal elastase <100 µg/g);
•- With a rapid calprotectin assay result via the IBDoc test (Bühlmann®) superior or equal to 250 µg/g;
•- Person affiliated or benefiting from a social security scheme;
•- Free, informed and written consent signed by the holders of parental authority and the investigator before any examination required by the research and oral and/or written consent by the participant (depending on his/her age).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 23
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Ongoing processing that can modulate the functionality of the CFTR (such as lumacaftor-ivacaftor protein therapy);
•- Patient already on polyethylene glycol or other laxative within 3 months before the inclusion visit;
•- Patient with diarrhea at inclusion (diarrhea will be defined as the presence of 3 or more stools / day in the 7 days prior to the inclusion visit);
•- Acute viral or bacterial diarrhea in the month prior to the inclusion visit (associated with fever);
•- Cure of oral or intravenous antibiotics or antifungals in the month preceding the collection of samples;
•- Change in background treatment in the month prior to the inclusion visit (oral or inhaled corticosteroid therapy, azithromycin, inhaled antibiotic therapy, inhaled antifungal agent, proton pump inhibitors);
•- Taking probiotics in the month before the inclusion visit;
•- Transplanted patient (on immunosuppressants);
•- Patient with IBD or celiac disease;
•- Patient with digestive perforation or risk of digestive perforation;
•- Patient with ileus or suspicion of intestinal obstruction, symptomatic stenosis;
•- History of hypersensitivity to macrogol or any of the excipients
•- Holders of parental authority enjoying judicial protection.

发起方

CHU de Bordeaux