Quality of Life and Gut Health in Pediatric Patients With Cystic Fibrosis
Probiotic Supplementation, Quality of Life and Gut Health in Pediatric Patients With Cystic Fibrosis
Oslo University Hospital
40 participants
Jan 2, 2024
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria6
- 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
- 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 Criteria6
- Other CFTR modulators commenced the last 6 months before inclusion
- Use of probiotics or prebiotics last 2 months
- Current pulmonary exacerbation
- CFTR modulators commenced the last 6 months before inclusion
- Use of probiotics or prebiotics last 2 months
- Current pulmonary exacerbation
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Interventions
Participants will recieve a multi-strain probiotic daily for 6 months
Participants will recieve placebo/ maltodextri daily for 6 months
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06284577