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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-18
SponsorOslo University Hospital

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

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Oslo University Hospital

Lead sponsor

Norwegian National Adivisory Unit on Rare Disorders

Collaborator