Polyethylene glycol and intestinal inflammation in cystic fibrosis

Phase 1

• Conditions: Cystic fibrosis; MedDRA version: 20.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-004958-29-FR
• Lead Sponsor: CHU de Bordeaux

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-04
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 23

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).

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Study the impact of a 3-month polyethylene glycol treatment on intestinal inflammation associated with cystic fibrosis in children aged 4 to 18 years, as measured by the fecal calprotectin assay.;Secondary Objective: Study the impact of a 3-month treatment with polyethylene glycol:<br>- On digestive symptoms and quality of life, <br>- On the intestinal microbiota (bacterial and fungal) <br>Study the co-evolution of inflammation between the gut and lungs (the gut-lung axis) during the 3 months of polyethylene glycol treatment.<br>;Primary end point(s): proportion of patients with faecal calprotectin <250 µg / g measured by an ELISA test 3 months after initiation of treatment with polyethylene glycol, testifying to the absence of intestinal inflammation or slight inflammation.;Timepoint(s) of evaluation of this end point: 3 months after initiation of treatment with polyethylene glycol