About this trial
The aim of the present study is to investigate the effect of probiotic supplementation on GI related quality of life, through a randomised placebo-controlled clinical trial. Moreover, the invetigators wish to study CF microbiota and intestinal inflammation in the setting of probiotic supplementation and newly started treatment with a highly effective CF-specific treatment, elexacaftor-tezacaftor-ivacaftor (ETI). The proposed project has the potential to increase QoL and decrease GI morbidity in children with CF. If successful, the results of this study can contribute to alter the care of CF patients by including supplementation of probiotics in routine CF care. Morever, the study can provide much needed insights to GI microbiota and inflammation in pediatric CF patients.
Eligibility criteria
Qualifiers
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
Disqualifiers
Other CFTR modulators commenced the last 6 months before inclusion
Use of probiotics or prebiotics last 2 months
Current pulmonary exacerbation
Age 3-18 years
Trial design
Treatments tested in this trial
- Multistrain Probiotic
- Placebo - maltodextrin
Treatment groups
Sponsors and collaborators
Oslo University Hospital
Lead sponsor
Norwegian National Adivisory Unit on Rare Disorders
Collaborator