Quality of Life and Gut Health in Pediatric Patients With Cystic Fibrosis

Launched by OSLO UNIVERSITY HOSPITAL · Feb 21, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how taking probiotics, which are good bacteria that can help gut health, might improve the quality of life for children with cystic fibrosis (CF). The study will also explore how these probiotics affect the bacteria in the gut and any inflammation in the intestines, especially in children who are starting a new CF treatment called elexacaftor-tezacaftor-ivacaftor (ETI). The goal is to see if adding probiotics to regular CF care can help reduce gut-related problems and make kids feel better overall.

To be part of this study, children must be between 2 and 18 years old and have specific CF gene mutations that make them eligible for the ETI treatment. They should also be registered in the Norwegian CF Register and agree to participate in research. However, children who have used other CF medications recently, taken probiotics in the last two months, or are currently experiencing a lung infection will not be able to join. Participants in the trial can expect to receive either the probiotics or a placebo (a treatment that has no active ingredients) and will help researchers understand the benefits of probiotics in managing cystic fibrosis.

Gender

ALL

Eligibility criteria

• 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