Investigating the impact of probiotics on gut health and quality of life in children with cystic fibrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effects of probiotic supplementation on gastrointestinal (GI) related quality of life in pediatric patients with cystic fibrosis (CF) through a randomized placebo-controlled trial. It includes two work packages: one observational and one interventional, where participants will be randomized to receive either probiotics or a placebo. The study will also explore the gut microbiota and intestinal inflammation in relation to a new CF treatment, elexacaftor-tezacaftor-ivacaftor (ETI). By assessing these factors, the study seeks to enhance the overall care and management of children with CF.

Why it matters

Who can join: the full rules

Inclusion criteria for WP1:

* CFTR mutations eligible for treatment with ETI
* Age 2-18 years. Majority of patients will be 2-6 years of age as ETI was approved from 6 years of age in 2022, and will be available for children above 2 years from 2024.
* Included in the Norwegian CF Register and consented to participation in CF general research biobank

Exclusion criteria for WP1:

* Other CFTR modulators commenced the last 6 months before inclusion
* Use of probiotics or prebiotics last 2 months
* Current pulmonary exacerbation

Inclusion criteria for WP2:

* Age 3-18 years
* CFTR modulator treatment naïve or treated with CFTR modulator for at least 6 months
* Included in the Norwegian CF Register and consented to participation in CF general research biobank

Exclusion criteria for WP2:

* CFTR modulators commenced the last 6 months before inclusion
* Use of probiotics or prebiotics last 2 months
* Current pulmonary exacerbation

Where it's running

• Oslo University Hospital
  Oslo, Norway Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.