An interventional study of Multistrain Probiotic and Placebo - maltodextrin in Cystic Fibrosis in Children, sponsored by Oslo University Hospital. Recruiting at 1 site in Norway. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-06-13.
Sponsored by Oslo University Hospital · Not applicable, Interventional, and Treatment
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.
The project targets pediatric patients with cystic fibrosis (CF), and has to work packages (WP). WP1 is an observational study, and WP2 is a randomised placebo-controlled clinical trial. The goal of the study is to investigate the effect of probiotics on pediatric CF patients' quality of life (QoL). Moreover the investigators wish to explore effects of both a highly effective CFTR modulator and probiotics on gut microbiota and intestinal inflammation.
The primary question it aims to answer are:
Secondary aims are to:
In WP1 participants will during routine examination before starting treatment with ETI be asked to deliver stool samples, and fill in QoL questionnaires. In WP2 participants will be randomized to intervention with probiotics or placebo, and the same parameters as in WP1 will also be collected.
1,606 studies on the registry are indexed under Cystic Fibrosis; 196 are open to participants now.
This study's planned enrollment of 40 is above the median of 36 across 1,051 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Oslo University Hospital is the lead sponsor of 830 studies on the registry; 146 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria for WP1:
Exclusion criteria for WP1:
Inclusion criteria for WP2:
Exclusion criteria for WP2:
Participants will recieve a multi-strain probiotic daily for 6 months
Dietary Supplement: Multistrain Probiotic
Participants will recieve maltodextrin daily for 6 months
Dietary Supplement: Placebo - maltodextrin
Participants will recieve a multi-strain probiotic daily for 6 months
Participants will recieve placebo/ maltodextri daily for 6 months
Changes in GI related QoL using the questionnaire PedsQL GI
PEDsQL GI has been validated for use in the CF population. Participants will be scored before and 6 months after treatment start with ETI (WP2), and before and after 6 months treatment with probiotics vs placebo (WP2).
Time frame: 0-6 months
Changes in microbiota
Stool samples for microbiota will be collected using a collection kit provided to the participants at recruitment, and then after 6 month of ETI treamtment (WP1), or probiotic/placebo (WP2). Microbiota analysis will be done using 16s rRNA amplicon sequencing and reduced metagenome sequencing.
Time frame: 0-6 months
Changes in intestinal inflammation
Stool samples for gut inflammation markers will be collected using a collection kit provided to the participants at recruitment and after 6 months of ETI treamtment (WP1), or probiotic/placebo (WP2. Levels of calprotectin, neopterin and myeloperoxidase will be measured.
Time frame: 0-6 months
Plan to share: No
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