Status:
UNKNOWN
Polyethylene Glycol and Intestinal Inflammation in Cystic Fibrosis
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
4-17 years
Phase:
PHASE2
Brief 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 F...
Detailed Description
Cystic fibrosis is one of the most frequent serious genetic diseases in France (7000 patients). It is the consequence of mutations in the CFTR gene, encoding a protein involved in the hydro-electrolyt...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 8 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04458129
Start Date
July 8 2020
End Date
July 8 2022
Last Update
July 7 2020
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