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Could a common laxative soothe gut inflammation in cystic fibrosis?

NCT ID NCT04458129

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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.

Show the full entry requirements

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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