Could a common laxative soothe gut inflammation in cystic fibrosis?
NCT ID NCT04458129
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial investigates whether polyethylene glycol (a laxative) can reduce intestinal inflammation in children with cystic fibrosis. The study includes children aged 4 to 17 with cystic fibrosis and pancreatic insufficiency who have elevated fecal calprotectin (a marker of gut inflammation). Participants take polyethylene glycol daily for 3 months, and the main goal is to see if their calprotectin levels drop below a certain threshold, indicating reduced inflammation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- polyethylene glycol (Macrogol 4000)
- What this could lead to
- If it works, this could offer a simple, non-drug way to manage gut inflammation in children with cystic fibrosis, improving digestive health.
- What could go wrong
- This is a small, early-phase trial with only 23 participants. The treatment may not reduce inflammation enough, and results may not apply to all patients.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
23 people
The number who actually took part.
- Started
-
Sep 2020
- Finished
-
Jul 2022
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
4 to 17 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
CHU de Bordeaux
Bordeaux, 33000, France
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