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

RecruitingNAAges 2 Years - 18 YearsAllOslo University Hospital
NCT06284577 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Multistrain Probiotic
  • Placebo - maltodextrin
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Where

1 site
Oslo University Hospital
Oslo, Norway
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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