Polyethylene Glycol and Intestinal Inflammation in Cystic Fibrosis

• Status: Not yet recruiting
• Trial end date: 2022-07-08
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of the study is to evaluate the effectiveness of polyethylene glycol treatment on intestinal inflammation in children with cystic fibrosis. In this test, a method adapted from the Fleming one-step scheme will be used. The success rate is measured by the proportion of patients with fecal calprotectin levels < 250 µg/g at 3 months after treatment initiation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.