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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIETARY_SUPPLEMENT

Multistrain Probiotic

Participants will recieve a multi-strain probiotic daily for 6 months

DIETARY_SUPPLEMENT

Placebo - maltodextrin

Participants will recieve placebo/ maltodextri daily for 6 months

Locations (1)

Oslo University Hospital
Oslo, Norway