Overview

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.